Bijlagen - HvA Kennisbank

Transcription

Bijlage 1: Overzicht interventies
Fysische therapie
Auteur
Doelgroep
Interventie +
vergelijking
Standaard behandeling?
Uitkomstmaten
Resultaat
De Bie
1998
Tussen 18 – 65 jaar. Trauma
niet ouder dan 24 uur. Pt.
met fracturen, open
wonden, onderliggende
abnormaliteiten voet en
been en slecht begrip
Nederlandse taal werden
uitgesloten van de studie.
2 soorten lasertherapie als
aanvulling. Hoge dosis
(5j/cm2) en lage dosis
(0,5J/cm2) vergeleken met
placebo.
4 weken brace + huiswerkoefeningen
en advies.
Pijn (0-10), Functie (0-100),
afwezig
werk/school/huishouden
(dg), tijd tot oppakken sport,
ADL beperking (0-10),
zwelling enkel (volume),
pressure treshold test,
subjectief herstel (0-10) en
tevredenheid herstel (0-10).
Placebo groep scoorde over het
algemeen beter. Klein verschil in
pijn. Significant verschil bij
functie, afwezigheid
werk/school/huishouden,
subjectief herstel en ADL
beperkingen. Het aantal
inversietrauma’s na 1 jaar was
significant hoger in de lage dosis
groep vergeleken met de andere
2 groepen. Hoge dosis en lage
dosis lasertherapie zoals
gebruikt in deze studie is niet
effectief in de behandeling!
Sandoval
2010
met ernstig enkelletsel,
aandoeningen die zwelling
en pijn kunnen
beïnvloeden, regelmatig
gebruik
ontstekingsremmers en
andere behandelingen
werden uitgesloten.
niet ouder dan 5 dagen. Pt.
met diabetes, vasculaire
aandoeningen, metalen
platen in onderbeen,
contralaterale blessure,
open wonden, pacemakers
en gebruik van diuretica
werden uitgesloten.
2 soorten HVPC als
aanvulling. Negatieve
polariteit en positieve
polariteit vergeleken met
standaard behandeling
alleen.
Eerste fase: ijzen, been omhoog,
isometrisch en actief oefenen zonder
weerstand tot pijngrens zonder dragen
gewicht. Tussenfase: ijzen, oefeningen
met steeds meer dragen van gewicht
tijdens lopen, oefeningen propriocepsis
op vaste ondergrond. Eindfase:
propriocepsis op wankele ondergrond,
PNF, ren activiteiten in S- en Z- vormen
en sprongen in alle richtingen.
Pijn in rust, palpatie en 4
bewegingen (0-10), zwelling
enkel (omtrek & volume),
ROM (goniometer), lopen
(staplengte, grote v/d passen
en loopsnelheid)
Aan het einde geen significant
verschil tussen de groepen. De
HVPC negatief scoorde echter
iets beter in alle uitkomstmaten
en bereikte het einde van de
behandeling sneller. Resultaten
laten vermoeden dat HVPC
negatief het herstel versnelt in
de eerste fase van herstel!
Zwelling enkel (omtrek &
volume), Subjectief functie
(adapted Hughston Clinic
Subjective Rating Scale for
Ankle Disorders).
Geen significant verschil tussen
de groepen. NMES zoals gebruikt
in deze studie is niet effectief in
het verminderen van zwelling of
verbeteren van de subjectieve
functie!
Man 2007
2 soorten NMES. Op de
spieren v/h onderbeen,
submotor elektrische
stimulatie vergeleken met
placebo.
met zelfde trauma in
afgelopen jaar, meerdere
blessures, diabetes,
ernstige spataderen en
blessures aan het bot
werden uitgesloten.
Voetballers tussen 18 – 26
jaar. Trauma niet ouder dan
8 uur.
Ultrasound therapie
vergeleken met placebo.
Advies enkel omhoog tijdens rust,
gewicht dragen op geblesseerde voet.
Tubigrip voor na de behandeling.
Pijn (0-10), enkel zwelling
(omtrek), ROM (goniometer),
dragen van gewicht (2
weegschalen).
Geen significant verschil tussen
de groepen. Ultrasound therapie
zoals gebruikt in deze studie niet
beter dan placebo!
Laser vergeleken met RICE
+ placebo en RICE alleen.
RICE: Rust, IJzen (3 x 20 min.)
Compressie (elastic wrap) en Elevatie.
Enkel zwelling (volume)
Laser + RICE had een significant
verschil in de vermindering van
zwelling na 24 en 72 uur. Laser +
RICE kan zwelling verminderen!
Auteur
Doelgroep
Interventie +
vergelijking
Uitkomstmaten
Resultaat
Bleakley
2006
Sporters en algemene
patiënten van 16 jaar en
ouder. Trauma niet ouder
dan 48 uur. Pt. met
blessures aan het bot,
positieve anterior drawer
test of talar tilt test,
meerdere blessures en
aandoeningen die met kou
te maken hebben werden
uitgesloten.
2 ijsprotocollen.
Intermitterend (10 min.
ijzen, 10 min. rust en weer
10 min. ijzen elke 2 uur)
vergeleken met standaard.
20 minuten constant ijzen elke 2 uur.
Subjectief functie (Binkley’s
lower extrimity functional
scale), Pijn (0-10) en enkel
zwelling (omtrek)
Significant verschil
intermitterend protocol
vergeleken met standaard.
Intermitterend had in de eerste
week minder pijn tijdens
activiteiten. Intermitterend
ijsprotocol kan de pijn in de
eerste week na het trauma
verminderen!
Nyanzi
1999
Stergioulas
2004
IJzen
Externe steunmiddelen
Auteur
Doelgroep
Interventie +
vergelijking
Uitkomstmaten
Resultaat
Lamb 2009
Ouder dan 16 jaar. Trauma
met fracturen groter dan
3mm en contra-indicaties
voor immobilisatie werden
uitgesloten.
3 groepen mechanisch
support. Aircast brace,
bledsoe boot of 10 dagen
below-knee cast vergeleken
met dubbele laag tubular
compression bandage.
Advies verminderen pijn en
zwelling. Behandeling volgens
gebruiksaanwijzing product.
Functie (Foot and Ankle
score), Kwaliteit van leven
(SF-12 short), subjectief
voordeel van support (0-10).
D. Beynnon
2006
Tussen 16 en 65 jaar.
Trauma niet ouder dan 72
uur. Pt. met geschiedenis
van inversietrauma,
abnormaal looppatroon
voor trauma, fractuur in de
enkels afgelopen 12
maanden, aanwijzingen
fractuur, syndesmosis
blessures, brandwonden,
scheur in de huid,
prikwonden, zwanger of
planning van
zwangerschap, chronische
ziekte, neurologische
aandoening en onwillig tot
therapietrouw werden
uitgesloten.
Graad 1: Elastic wrap, airstirrup ankle brace, airstirrup ankle brace
gecombineerd met elastic
wrap.
Graad 2: Elastic wrap, airstirrup ankle brace, airstirrup ankle brace
gecombineerd met elastic
wrap of fiberglass walking
cast (10 dg) gevolgd door
elastic wrap.
Graad 3: Air stirrup ankle
brace of fiberglass walking
(10 dg) gevolgd door elastic
wrap.
Fase 1: Krukken (wanneer nodig),
ijzen (20 min.) en omhoog houden
(15 min.). ROM oefeningen (ook
passief), Achillespees rekken en
rondjes van de enkel.
Inversie/eversie/teen buigen met
weerstand (handdoek) en wanneer
het goed voelt lopen, zwemmen en
fietsen.
Fase 2: Warm/koud behandeling,
krachttraining
(eversie/inversie/dorsaal- en
plantairflexie), op tenen en hielen
staan,.
Fase 3: Behendigheid training,
sport-specifieke training, balanceboard training, weerstand met een
Thera band en balans.
1 uitkomstmaten: Tijd tot
het weer kunnen lopen,
traplopen, volledig dragen
van gewicht.
Below-knee cast had een sneller
herstel en een belangrijk verschil na 3
maanden op de enkel functie, pijn,
symptomen en activiteiten
vergeleken met de tubular
compression. Aircast had een verschil
in enkelfunctie vergeleken met
tubular compression maar niet op de
andere uitkomstmaten. Bledsoe boot
had geen voordeel vergeleken met
tubular compression. Na 9 maanden
geen significanten verschillen.
Below-knee cast wordt aangeraden
door de wijde spreiding van
voordeel. Aircast is een goede
vervanging voor de below-knee cast
(indien nodig)!
Graad 1: Air-stirrup gecombineerd
met elastic wrap zorgde voor een
gehalveerde tijd tot het traplopen en
normaal lopen vergeleken met airstirrup of elastic wrap alleen.
Graad 2: Air-stirrup gecombineerd
met elastic wrap zorgde voor de
kortste terugkeer naar het normaal
lopen en traplopen.
Graad 3: Geen verschil in tijd.
Na 6 maanden was er geen verschil
tussen de behandelingen wat betreft
het aantal nieuwe inversietrauma’s.
Behandeling van graad 1 en 2 kan
het beste gebeuren met een Airstirrup gecombineerd met elastic
wrap. Dit zorgt voor een eerdere
terugkeer naar het functioneren
voor het trauma.
ste
de
2 uitkomstmaten: Tijd tot
het volledig functioneren in
het dagelijks leven, rennen.
de
3 uitkomstmaten:
Enkelfunctie en ROM
(Karlsson’s functional scale en
goniometer)
Trainingsprincipes
Auteur
Doelgroep
Interventie +
vergelijking
Uitkomstmaten
Resultaat
Bassett
2007
Gediagnosticeerd
inversietrauma (geen
fracturen etc.). Pt. die
slecht Engels verstaan
werden uitgesloten.
Standaard behandeling. 2
groepen. Groep die het
programma thuis uitvoert
(alleen kliniek bij overgang
fase) vergeleken met het
programma op de kliniek
(afspraken zoveel nodig,
oefeningen/activiteiten
onder toezicht).
Functie (Lower limb task
questionnaire en Motor
activity scale), therapietrouw
(aanwezigheid afspraken,
aantal pt. bij laatste afspraak,
Sports Injury Rehabilitation
Adherence Scale), subjectief
therapietrouw (0-5).
Manal
2010
Sporters tussen 20-35 jaar.
3 weken na trauma. Pt. die
niet voldeden aan
plyometrische training
inclusiecriteria voldoen
werden uitgesloten. Pt. met
graad 3 inversietrauma,
fracturen, subluxaties,
abnormaliteiten van de
voet, inversietrauma
geschiedenis, chronische
aandoeningen en
aandoeningen aan de
onderste extremiteit
werden uitgesloten.
met graad 3
inversietrauma, fractuur,
meerdere blessures,
contra-indicatie voor ijzen,
slecht verstaan Engelse taal
of gebruik van drugs en
alcohol werden uitgesloten.
Eerst 3 weken standaard.
Daarna plyometrische
training (2x per week,
weken volgens Miller et al.)
vergeleken met
weerstandstraining (2x per
week).
36 – 48 uur: RICE. Rust, ijzen,
compressie (bandage of tubigrip),
elevatie. ROM oefeningen binnen
de pijngrens.
10 – 14 dagen: ROM (plantairflexie,
dorsaalflexie, inversie en eversie),
Krachttraining (lichte weerstand),
kuit en hiel strekken, tapen van
enkel. Gewichtdragen en balans.
Uitwerken, zwaarder maken tot
volledig herstel.
RICE. Rust, ijzen, compressie en
elevatie. Na verdwijning zwelling
(meestal 3-5 dg.) ROM en
oefeningen voor het dragen van
gewicht.
De groepen hadden dezelfde scores
op enkelfunctie, therapietrouw en
motivatie. De thuisgroep had een
significant hoger percentage van
aanwezigheid bij afspraken en een
betere score in het afmaken van het
programma.
Thuistherapie met therapietrouw
strategieën is een veilige en goede
optie voor patiënten met een
inversietrauma!
Er was een significant hogere score
van de plyometrische groep wat
betreft de functiescore.
Week 1: IJzen (intermitterend, 3 x
per dag) en compressie.
Subjectief enkelfunctie
(Lower extremity functional
scale), pijn tijdens rust en
activiteiten (0-10), zwelling
(omtrek) en activiteiten
(physical activity logger),
Sports ankle rating score
(lopen, ROM, kracht,
stabiliteit) en subjectief
functiescore.
Bleakley
2010
Versnelde interventie (in
eerste week al oefeningen
naast standaard)
vergeleken met standaard
interventie.
Week 2 – 4: Krachttraining,
neuromusculair trainen, sport
specifieke oefeningen (30 minuten
elke week).
Enkelfunctie (2 voor
spierkracht en
uithoudingsvermogen
(traplopen en op hiel staan),
1 stabiliteit (op tenen staan)
en 1 voor balans (op 1 been
staan) Kaikkonen et al.)
Dynamische spierkracht
(biodex system 3
dynamometer and biodex
advantage software package).
Beide groepen zijn goed voor het
verbeteren van spierkracht.
Plyometrische training is echter
effectiever in het verbeteren van de
enkelfunctie!
Er was een significant betere score
op enkelfunctie voor de oefengroep.
Activiteitniveau was significant hoger
in de oefengroep. Er was geen
verschil wat betreft pijn of zwelling
en in beide groepen waren er 2 die
opnieuw een inversietrauma kregen.
De versnelde interventie scoort op
de korte termijn beter op
enkelfunctie en activiteitenniveau!
Hupperets
2009
Sporters tussen 12 – 70 jaar
(uiteindelijk gem. 28 jaar
met 11 jaar spreiding).
Trauma niet ouder dan 2
maanden. Pt. die niet de
vragenlijst ingevuld
teruggaven werden
uitgesloten.
Propriocepsis training
zonder toezicht.
Standaard behandeling eerst
afgerond (volgens KNGF richtlijn).
Zelfrapportage van inversies
van de enkel (zwikken),
Opnieuw inversietrauma’s die
leiden tot het niet kunnen
sporten en dat leidt tot
kosten in de
gezondheidszorg.
Van Rijn
2007
die in de afgelopen 2 jaar al
een inversietrauma hebben
gehad werden uitgesloten.
Standaard behandeling
gecombineerd met
oefeningen (extra
training/oefeningen)
vergeleken met alleen de
standaard.
Vroegtijdig ROM oefeningen,
advies huiswerkoefeningen,
vroegtijdig dragen van gewicht, zo
vroeg mogelijk activiteiten gaan
doen. De enkel werd getapet indien
nodig.
Subjectief herstel (0-10),
opnieuw krijgen van
inversietrauma, tevredenheid
herstel (1-3), instabiliteit (op
1 been staan), ROM
(electronic digital
inclinometer).
22% in de propriocepsis groep en
33% in de controle groep
rapporteerde een opnieuw
inversietrauma. De propriocepsis
training is geassocieerd met een 35%
vermindering in risico op het
opnieuw krijgen van een
inversietrauma.
Het gebruik van een propriocepsis
programma na de standaard
behandeling is effectief voor de
preventie van inversietrauma’s!
Er was een significant hogere
tevredenheid over de therapie bij de
groep met extra oefeningen. Op alle
andere uitkomstmaten was geen
verschil.
Er is een kleine aanwijzing dat
vanwege het risico op het opnieuw
krijgen van een inversietrauma, de
standaardbehandeling met
oefeningen de beste optie is. De
tevredenheid over de behandeling is
groter bij deze groep dan bij de
groep standaard behandeling!
Bijlage 2: CAT-analyses
CAT-analyse 1
Cryotherapy for acute ankle sprains: a randomised controlled study of two different icing
protocols (Bleakley CM, McDonough SM, MacAuley DC)
Punt 1: In/exclusiecriteria
Score: 1 punt
Toelichting:
“To be eligible for inclusion in the study, subjects had to have sustained a mild/moderate ankle sprain
within the preceding 48 hours. A three point grading scale was used to determine the severity of the sprain.
Subjects testing positive on the anterior drawer test or talar tilt test were automatically excluded from the trial.
Delayed physical examination for the presence or absence of a ligament lesion gives diagnostic quality equal to
that of arthroscopy. Other exclusion criteria were subjects <16 years old, a bony injury, multiple injuries, or the
presence of any cold related conditions. The exclusion of a bony injury was made using radiography and/or the
Ottawa ankle rules classification.”
Punt 2: Interventie
Score: 1 punt
Toelichting:
“The mode of cryotherapy was standardised across groups and consisted of melting iced water (0°C) in a
standard sized pack. Plastic ice bags (20 cm620 cm) were completely filled with water, placed in a freezer, and
removed when frozen. Before application, the packs were held under hot water for 30 seconds and wrapped in
a single layer of standardised towelling (moistened until just dripping wet). Standard ice application consisted
of 20 minutes of continuous ice treatment performed every two hours. This duration of treatment has been
recommended in the literature and is also commonly used in the clinical setting. The intermittent ice group
applied ice for 10 minutes. The pack was then removed, and the ankle was rested at room temperature for10
minutes. The ice was then reapplied for a further 10 minutes. Again intermittent treatments were repeated
every two hours, and both groups continued their respective treatments over the first 72 hours of injury.
Previous studies have shown that the mode and duration of cryotherapy applied in the intermittent protocol
reduces skin temperature to 5°C immediately after treatment. Subjects were responsible for ice pack
preparation, and all treatments were self administered. At the time of the trial, subjects were given a verbal
explanation of the correct procedure for ice pack preparation and application, which was supplemented with
step by step written instructions. Patient compliance was monitored using a treatment diary, which was
returned to the secondary researcher one week after the injury. Ankle mobility (ankle circles, 30 repetitions
63), calf stretching (non-weight bearing, 30 second holds x 5), and basic proprioceptive exercises were
standardized between groups by means of an advice sheet. Subjects were encouraged to perform these
exercises once a day for the first week.”
Punt 3: Randomisatie
Score: 1 punt
Toelichting:
“Before the start of the trial, an independent researcher, who had no contact with the study participants or
input into the day to day proceedings of the trial, generated the randomisation
sequence using computer software. Stratified randomisation was used with two strata: sports and general
population. Separate block randomisation sequences were produced for each subset of participants. An
allocation ratio of 1:1 was used with a block size of 4.”
Punt 4: Blindering
Score: 1 punten
Opmerking: Patiënt niet geblindeerd. Onderzoekers wel?
Toelichting:
“The primary investigator, who remained blinded to group assignment until completion of data collection and
analyses, carried out subject recruitment, gained informed consent, and assessed all baseline and follow up
measurements. Three secondary researchers assigned subjects to either the standard (n = 46) or intermittent
(n = 43) group and provided advice on the appropriate cryotherapy treatment and standardised treatment.
Group assignment was concealed from the secondary researchers, using opaque sealed envelopes, until
subject recruitment and informed consent was completed.”
Punt 5: Confounding
Score: 1 punt
Toelichting:
“Table 1 shows the basic and clinical characteristics of patients in each group. Table 2 highlights that
at baseline there were no significant differences between groups in terms of ankle function, pain at rest or on
activity, or swelling. The degree of compliance in both groups was good: mean (SEM) number of ice treatments
over the first 72 hours was 5.7 (0.41) in the standard group and 5.5 (0.42) in the intermittent group (t = 0.21, p
= 0.84).”
Punt 6: Therapietrouw en contaminatie
Score: 1 punt
Opmerking: De therapietrouw is bijgehouden door het invullen van een dagboek. Er is mogelijk
sprake van contaminatie doordat ze in het onderzoek niet het aantal patiënten hebben bereikt die ze
wilde bereiken. Onder toelichting staat het stukje tekst waar uitgelegd staat waarom ze dit aantal
wilde bereiken.
Toelichting:
“The degree of compliance in both groups was good: mean (SEM) number of ice treatments over the first 72
hours was 5.7 (0.41) in the standard group and 5.5 (0.42) in the intermittent group (t = 0.21, p = 0.84).”
“A randomised controlled pilot study (n = 15) was used to determine sample size and recruitment targets. The
power analysis calculations based on the results showed that assuming 80% power and a 0.05 a value, and
based on a between-within repeated measures analysis of variance design, a minimum number of 40 subjects
would be required for each intervention group, to detect a mean difference of 9 (in either direction) on the
questionnaire for the primary outcome. Using information from a previous study in the same hospital
department, a 10% attrition rate was estimated at each phase of the trial, therefore this study aimed to recruit
a total of 128 subjects. Recruitment was planned for a 52 week period, and an average of 2.5 new subjects
would be recruited a week.”
Punt 7: Co-interventie
Score: 1 punt
Toelichting: Er wordt beschreven dat de patiënten naast het ijzen ook oefeningen krijgen. Dit is
echter een onderdeel van de onderzochte interventie waardoor het niet opgevat wordt als cointerventie.
Punt 8: Uitkomstmeting
Score: 1 punt
Toelichting:
“The primary outcome measure was subjective ankle function, assessed using Binkley’s lower extremity
functional scale. This scale has excellent test retest reliability and good construct validity.
Pain was assessed using a 10 cm visual analogue scale, marked ‘‘no pain’’ at one end and ‘‘worst pain ever’’ at
the other. This form of assessment was considered most appropriate because of its high level of repeatability
when used serially on the same patient.
Swelling was measured using a figure of eight method. All measurements were performed using one quarter
inch wide plastic tape following a standard written protocol. A mean of two measures, from both the injured
and uninjured ankle, was recorded. To establish the degree of swelling on the injured side, a difference value
was calculated by subtracting the mean value for swelling for the uninjured ankle from the injured ankle. The
figure of eight method has been shown to be a highly reliable and valid tool for measuring the girth of both
healthy and oedematous ankles.”
Punt 9: Loss-to-follow up
Score: 0 punten
Opmerking: Er zijn best veel patiënten uit het onderzoek gehaald i.v.m. het niet komen naar de
follow up’s.
Toelichting:
Punt 10: Data-analyse
Score: 1 punt
Toelichting:
“Intention to treat analysis Nineteen subjects were lost to follow up, and therefore full datasets from 70
subjects were available for the intention to treat analysis. All 70 of these patients received the relevant
intervention as allocated and all of them complied adequately with treatment. Subjects were deemed to be
compliant if they applied ice at least once each day over the first 72 hours, as rated by their patient diaries.
None of them were considered protocol violators, and it was not deemed necessary to undertake an additional
per protocol analysis.”
Score: 9 punten
CAT-analyse 2
Low-level laser therapy in ankle sprains: A randomized clinical trial. (de Bie RA, de Vet
HCW, Lenssen TF, van den Wildenberg FAJM, Kootstra G, Knipschild PG).
Score: 1 punt
Toelichting:
“Patients who reported between September l, 1993, and December 31, 1995, to the accident and emergency
department of a university hospital with acute lateral ankle sprain, who were between 18 and 65 years old, and
whose injury was not older than 24 hours were selected by the physician on call. In addition, patients with
fractures (confirmed by obligatory radiography), direct open trauma, and underlying abnormalities of the foot
and/or legs were excluded. Finally, those with systemic diseases (eg, rheumatoid arthritis or diabetes) and
mental handicap were excluded, as well as people with difficulties with the Dutch language. Patients could also
be excluded for practical reasons, for instance, if they lived too far away or if they could be expected not to
attend all therapy sessions (eg, going on holiday, working abroad).”
Punt 2: Interventie
Score: 1 punt
Toelichting:
“All patients received a standardized treatment regimen that consisted of 4 days' elastic wrapping followed by
3.5 weeks of bracing with a Push ankle brace. We also provided standardized patient information and
standardized home exercises. The home exercises consisted of simple mobility exercises for the ankle, learning
to bear weight on the injured foot, and later learning to regain balance and ensure a proper gait pattern. The
additional 904nm LT was similar in all three groups, except for the dose. Laser specifications are given in table
1. Laser dose at skin level was 0.5J/cm 2 in the low-dose group, 5J/cm 2 in the high-dose group, and 0J/cm 2 in
the placebo group. The target tissue was considered to lie a maximum of lcm under the surface of the skin.
Energy density at tissue level was calculated to be 0.07J/cm 2, 0.7J/cm 2, and 0J/cm 2 for each dose,
respectively. Laser output was validated before the start and at the end of the trial and was checked at regular
intervals during the trial by an independent party.”
“The most painful area on the lateral side of the ankle was chosen as the target location. The patient indicated
the painful area. This was consequently checked by an algometer. The target area was circumscribed with a
waterproof marker during the first visit. Before LT was applied, the area was cleaned with alcohol (96%) to
minimize backscatter and reflection from fatty skin. Then the probe was placed perpendicularly in the center of
the circumscribed area, directly on the skin, thereby preventing energy loss due to divergence. All three groups
followed the same treatment schedule: 5 treatment sessions in the first week, 3 treatment sessions in the
second week, and 2 treatment sessions per week in the third and fourth weeks, adding up to 12 treatment
sessions during a 4-week intervention period. At each treatment session, every patient received 200 seconds
of laser therapy.”
Score: 1 punt
Toelichting:
“Patients were stratified by severity of injury (mild or severe) and sports participation (participation or
nonparticipation in sports activities) to prevent unequal distributions by chance for these prognostic factors
between treatment groups. After informed consent, 217 consecutive patients were randomly allocated to one
of three groups by means of a computergenerated table, with a random permuted block size of 3. The first
group (n = 74) received low-dose LT, the second Group (n = 72) received high-dose LT, and the third group (n =
71) received placebo LT.”
Punt 4: Blindering
Score: 1 punt
Opmerking: Patiënten, therapeuten, assessors en analisten waren geblindeerd.
Toelichting:
“Patients, therapists, outcome assessors, and analysts were blinded to the treatments given.”
“Blinding of the treatment setting was ensured by randomizing the three settings (high, low, or placebo) over
21 treatment codes (7 for each group) so that in the event of unmasking one of the codes, the trial did not have
to be halted. This, however, did not occur.”
Punt 5: Confounding
Score: 1 punt
Toelichting:
“The three treatment groups were similar with respect to demographic characteristics and baseline measures,
although age and gender differed slightly in the high-dose Group compared with the other two groups (table
2).”
Score: 0 punten
Opmerking: Best een aantal behandelingen zijn gemist door patiënten.
Toelichting:
“All patients were present for baseline measurements, yet 2.1% of all treatment sessions were missed and thus
formed gaps in the data set (43 of 2,064 treatment sessions; 0.4% from the low-dose group, 0.7% from the
high-dose group and 1% from the placebo group). Seven patients missed only one treatment session because
of illness or work. These missing data were substituted by the mean value of preceding and following
measurements in the data set in both intention-to-treat and per-protocol analyses. Eight patients missed 21
treatment sessions because they believed they were cured. For these patients, the last known entry was
substituted for the intention-to-treat analysis. Two of these patients were in the low dose group, 1 was in the
high-dose group, and 5 were in the placebo group. Three patients withdrew from the trial without being cured.
These were 2 patients from the low-dose group, 1 of whom missed two treatment sessions in a row and one of
whom stayed away 10 days after trauma; 1 patient from the high-dose Group stayed away 8 days after initial
trauma. For these patients, the last known value was substituted for the intention-to-treat analysis.”
Score: 1 punt
Opmerking: Het is duidelijk aangegeven in de tekst dat de patiënten medicatie mochten nemen. Dit
werd ook vastgelegd.
Toelichting:
“We allowed patients to take standardized pain medication(Paracetamol, b 500mg; maximum dosage 1 tablet
every 4 hours). These drugs were provided at intake, and the patients kept a record of the amount they took.”
Score: 1 punt
Toelichting:
“In this trial, we considered the most important outcome measures those that were capable of reflecting the
actual state of the complaint from the patients' point of view. Therefore, the primary measures of effect were
perceived pain measured on a scale of 0 to 10 and function. For measurement of pain, we specifically chose a
scale of 0 to 10 because this way of grading pain is familiar and easy to use for patients and other assessors.
Function was scored on a 100-point scale that combined the items pain, instability, weight bearing, swelling,
and gait pattern. The scale has been validated and is used as both a diagnostic and a prognostic instrument.
Secondary outcome measures were total days of sick leave from work, school, or housekeeping because of
trauma and moment of reuptake of sports (measured in days since onset of trauma). We also measured
limitation in activities of daily living (ADL) by use of a scale of 0 to 10, swelling of the ankle by means of the
volumetric difference between swelling at intake and at several points during the intervention, pressure
threshold test (in kg/cm 2) by means of an algometer, subjective recovery by use of a scale of 0 to 10, and
satisfaction about recovery rate and received treatment by use of a scale of 0 to 10.”
Score: 1 punt?
Toelichting:
“All patients were present for baseline measurements, yet in the follow-up 3.6% to 8.3% of the patients were
lost to follow-up as time passed. The low-dose group showed 6 losses to follow-up after 1 year; 4 patients had
moved, 1 patient did not respond to either written or telephoned requests, and 1 patient's telephone was
disconnected. In the high-dose group, 2 patients had moved and 1 patient had left an erratic telephone
number; thus 3 patients in total were missed. The placebo group showed 8 losses to follow-up after 1 year; 6
patients had moved, 1 patient's telephone was disconnected, and 1 patient had no telephone and did not
respond to written requests.”
Score: 1 punt
Toelichting:
“Subsequently, the data were analyzed with SPSSWIN/PC statistical software. Analysis was performed in a
blinded manner and according to the intention-to-treat principle: all participants, including those with poor
compliance and those who had withdrawn from therapy, remained in the group to which they were assigned
by randomization. Subsequently, a per-protocol analysis was performed to see whether protocol deviations
influenced the results.”
Score: 9 punten
CAT-analyse 3
Mechanical support for acute, severe ankle sprain: a pragmatic, muticentre, randomised
controlled trial. (Lamb SE, Marsh JL, Hutton JL, Nakash R, Cooke MW.)
Score: 1 punt
Toelichting:
“Participants with severe ankle sprain were recruited between April, 2003, and July, 2005, from eight
emergency departments across England. Patients had to be over 16 years of age (to ensure skeletal maturity,
and avoid inclusion of epiphyseal injuries that would not be managed with the treatments tested), and unable
to bear weight for at least 3 days after the injury. Weight-bearing status is used to indicate severity of sprains,
since clinical grading is not possible in the acute phase. People with flake fractures of less than 3 mm were
included, because such fractures should be treated as soft-tissue injuries;3 all other recent fractures were
excluded. All participants had a radiograph, since the Ottawa criteria specify inability to bear weight as an
indication for radiography.3 Patients were excluded from the trial if they had contraindications to
immobilisation (eg, high risk of deep-vein thrombosis, as assessed by the recruiting clinician), or if the injury
had occurred more than 7 days previously.”
Punt 2: Interventie
Score: 1 punt
Opmerking: Niet duidelijk wat hun protocol precies inhoud.
Toelichting:
“Plaster technicians, physiotherapists, and nurses were responsible for applying the supports, and all were
provided with training. The treatment packages have been described in detail elsewhere. In summary, each
participant had their device fitted individually to ensure correct fit and comfort. Sizing was in accordance with
the manufacturers’ instructions. Tubular compression bandage was applied as a double layer, from the tibial
tuberosity to the base of the toes. The below-knee cast
was a synthetic non-flexible cast, applied from the tibial tuberosity to the base of the toes, and was lined and
padded. Protocols for progression of weight-bearing and activity were determined by the manufacturers’
recommendations, recent research protocols, and results of a national survey of practice completed in the
planning phase of the trial. Participants were provided with written and verbal instructions on when to remove
the support (customised to each device), washing of the
support, regular elevation of the leg while it was swollen, gentle mobilising exercises, pain control and
application of ice packs, and what to do in the event of difficulties with the support. All participants were
provided with elbow crutches. Additional physical therapy techniques were not included in the trial treatment
protocol. If additional treatment was deemed necessary at any point
after randomisation, this use of treatment was quantifi ed by self-report questionnaire and considered as
descriptive data alongside the outcomes of the trial.”
Score: 1 punt
Toelichting:
“Randomisation was stratified by centre, and administered independently by a central telephone
randomisation centre (Birmingham Cancer Trials Service), ensuring allocation concealment.”
Punt 4: Blindering
Score: 1 punt
Opmerking: Behandelaar en patiënt kunnen niet geblindeerd zijn in dit onderzoek.
Toelichting:
“Researchers masked to the treatment allocation completed data entry.”
Punt 5: Confounding
Score: 1 punten
Opmerking: Volgens de tekst zijn ze gelijk. Ik denk dat de groep ‘aircast’ aan het begin over het
algemeen overal iets lager scoort.
Toelichting:
“Table 1 shows the baseline characteristics of participants. Ankle function was substantially impaired in all
participants. The median interval between time of injury and application of treatment was 3 days (IQR 2 days),
with no differences between the groups.”
Score: 0 punten
Opmerking: Therapietrouw is moeilijk te meten en er zijn andere behandelingen toegestaan die ook
nog eens verschillen van elkaar.
Toelichting:
- “A limitation of our study was that we were unable to measure compliance with the supports accurately.”
Punt 7: Co-interventies
Score: 0 punten
Opmerking: In tabel 3 staat wat voor hulp ze hebben gezocht. Dit is echter heel algemeen.
Toelichting: zie tabel hierboven.
Score: 1 punt
Toelichting:
“The primary outcome was quality of ankle function, measured with the Foot and Ankle Score (FAOS11). The
FAOS also includes assessments of pain, symptoms, activities of daily living, and ability to do sports. All
outcomes on the FAOS are given a score from 0 to 100, where 0 indicates extreme symptoms and 100 indicates
no symptoms. Generic health-related quality of life was measured with the short-form 12 (SF-12 version 1),12
in which physical and mental quality of life were each given
a score from 0 to 100, the population norm being 50. We used a visual analogue to capture self-perceived
benefit of the ankle supports (score 0–10, where 0 indicates no benefit and 10 indicates maximum benefit).
Scores on the Functional Limitations Profi le (the UK version of the Sickness Impact profile13) were obtained,
but not reported; they proved difficult to complete, since patients found the response categories difficult to
understand and complete. We obtained scores on two additional visual analogue scales of pain, and reported
our findings elsewhere. Participants were asked to report additional treatments, including reattendance at the
emergency department,
imaging, and treatment in primary care, secondary care, or the private sector.”
Score: 0 punten (veel loss-to-follow up)
Toelichting:
“There were no differences in loss to follow-up between the trial groups, and no suggestion of
differences between those lost to follow-up and those remaining in the trial at 9 months.”
Score: 1 punt
Toelichting:
“Analyses were by intention to treat. Data were summarised as mean (SD) unless otherwise stated.”
Score: 7 punten
Algemene opmerkingen:
In dit artikel wordt niet vergeleken met het niet hebben van zo’n support.
CAT-analyse 4
Effect of high-voltage pulsed current plus conventional treatment on acute ankle sprain
(Sandoval MC, Ramirez C, Camargo DM, Salvini TF).
Score: 1 punt
Toelichting:
“Inclusion criteria were: post-traumatic edema caused by ankle sprains classified as mild (minimal pain and
functional limitations, without hematoma, normal gait) or moderate (limping gait, localized edema, moderate
functional loss) within the first 96 hours after injury and with positive anterior drawer signs or lateral tilt in the
ankle joint. Participants were excluded if they had severe sprains (severe edema and hematoma, inability to
support weight and total function loss) or diseases that could interfere with the edema and pain (skin lesions,
systemic diseases or prior trauma), and if they were making regular use of anti-inflammatory drugs or had
been subjected to treatment, such as traction, massage, immobilization or manual therapy.”
Punt 2: Interventie
Score: 1 punt
Toelichting:
“Conventional treatment
The three groups underwent a physical therapy treatment often recommended for ankle sprain:
- Initial phase:
cryotherapy (bag of crushed ice for 20 minutes), around the entire ankle joint, combined with elevation of the
affected limb, isometric and unresisted active exercises in all degrees of freedom of the ankle joint, until the
limits of pain without weight bearing;
- Intermediate phase:
introduced when the unresisted active movements were performed without pain. Cryotherapy maintained
during this period. Introduction of exercises with progressive loading, progressive weight bearing during gait
and proprioceptive exercises on stable surfaces;
- Advanced phase:
introduced when the participants performed resistance exercises without pain. Proprioceptive training on
unstable surfaces. Strengthening with proprioceptive neuromuscular facilitation and elastic bands. Introduction
of running activities in S- and Z-shaped paths, and jumps in all directions.
HVPC parameters
A high-voltage stimulator (Intelect 500, Chattanooga Corp, Chattanooga, TN, USA) was used, with a direct
monophasic pulsed current and twin spikes of 5 and 8μs separated by an interpulse interval of 75μs. Monopolar
stimulation was used with a dispersive electrode placed on the lumbar region and two active
electrodes applied to the internal and external malleolus of the ankle. The current intensity was at submotor
level, i.e., too weak to elicit a visible motor response. The intensities were chosen based upon animal studies
that reported positive results. Because the participants were in the acute phase of injury, this intensity would
avoid the risks of generating muscle contractions and increase the trauma. The choice of polarity depended
on the group allocation, and the frequency used was 120 pps. HVPC was applied once a day for 30 minutes. The
equipment was calibrated prior to the intervention, using an oscilloscope (Tektronix TDS 1002) to verify the
selected parameters.”
Score: 1 punt
Toelichting:
“Block allocation was used to avoid possible selection bias in the allocation of treatments and to ensure that the
three groups were balanced in their baseline characteristics. The block allocation sequence was generated by
means of a random number table and, after that, the allocation of treatments to patients was performed.”
Punt 4: Blindering
Score: 1 punt
Opmerking: Patiënten en therapeuten geblindeerd.
Toelichting:
“Assessments and interventions were made, respectively, by two trained physical therapists with no access
to the identification of the treatment groups or the type of polarity used in the HVPC.”
Punt 5: Confounding
Score: 1 punt
Opmerking: Er is volgens de tekst een verschil aan het begin van het onderzoek in de mate van
plantairflexie. Dit is ook een uitkomstmaat. Ze kunnen echter wel het verschil in verbeteringen
vergelijken met elkaar.
Toelichting:
“The baseline characteristics, such as gender, age, dominant limb and clinical history, were homogeneous. In 27
participants (96.4%), the right limb was the dominant limb, although only 10 of them had suffered the injury to
that limb. The mean postsprain period for the three groups was 31.4±17.6 hours and no difference was
observed between them. Overall, trauma caused by forced inversion was the most common cause of sprains
(n=22). This was the first episode of sprain for the majority of the assessed participants (n=17; Table 1).
The analysis of the initial assessments found no statistical differences between groups, except for plantar flexion
ROM (p=0.03; Table 2).”
Score: 0 punten
Opmerking: Er wordt niks beschreven over de therapietrouw. Daarnaast wordt er in de tekst
gesproken over een ‘beperkende factor’ voor duidelijke verschillen in het onderzoek.
Toelichting:
“The number of participants (n=28) may have been a limiting factor for the identification of statistical
differences.”
Score: 0 punten
Toelichting:
“Hier wordt niets over gezegd.”
Score: 1 punt
Toelichting:
“The following dependent variables were considered: pain, ROM, edema and some gait parameters.
Pain was assessed at rest, on palpation and in all four movements of the ankle (dorsal flexion, plantar flexion,
eversion and inversion), using a horizontal visual analog scale (VAS) ranging from 0 to 10 cm, where 0
represented no pain and 10 represented the worst pain experienced by the participant. The participants were
also asked to indicate the degree of pain on the VAS, and the distance to the location marked was then
measured and recorded in cm.
The edema was measured by means of girth measurement and water displacement volumetry. The first was
measured with a tape measure in two places: around the ankle on the distal end of the lateral malleolus and
around the foot, on the highest part of the longitudinal internal arch. The mean was taken between the two
measurements for each limb, and the differences between right and left limbs were recorded. Water
displacement volumetry was chosen because some authors consider it as the gold standard for measuring
edema20. A volumetric tank with an output for excess water into a graduated cylinder of 500 ml was used. The
participant was instructed to sit on a chair and slowly introduced the affected limb into water with the knee at
90° of flexion and the ankle in neutral position, until it was fully supported by the surface of the foot at the
bottom of the tank. The volume of the displaced water was then measured in the graded cylinder. Finally, the
same procedures were performed with the contralateral limb.
The ROMs of dorsal and plantar flexion, inversion and eversion of both ankles were measured with a standard
goniometer, following the protocol of Norkin and White. All movements started with the ankle at an angle of
90° between the leg and foot. For data analysis, the differences between the ankles were used.
Finally, the following descriptive gait variables were evaluated: step length, stride length and gait velocity. For
these measurements, the participant was instructed to walk on a black carpet where the footprints were
recorded and the step and stride length were measured. Gait velocity was evaluated by recording the number of
steps per minute.”
Score: 1 punt
Toelichting:
“Er wordt niet gesproken over de loss-to-follow up. Wel is in de tabellen te zien dat het aantal personen niet is
veranderd van het begin tot eind. Het kan echter ook zo zijn dat ze met meer dan 28 personen begonnen en
dat zij deze personen er uit hebben gehaald toen zij niet meer kwamen naar de follow up’s (er wordt echter
wel vermeld bij in/exclusiecriteria dat er 28 personen werden betrokken bij het onderzoek).”
Score: 0 punten
Toelichting:
“Er wordt niet gesproken over een ‘intention to treat’ analyse. In de tekst wordt wel beschreven wat ze
gebruikten voor het analyseren van de uitkomsten: For this analysis, oneway ANOVA was used.
Meer informatie is te vinden onder het kopje ‘statistical analysis’”.
Score: 7 punten
CAT-analyse 5
Home-based physical therapy intervention with adherence-enchancing strategies versus
clinic-based management for patients with ankle sprains. (Bassett SF, Prapavessis H)
Score: 1 punt
Toelichting:
“Fifty-two people diagnosed with an acute ankle sprain (first-time or recurrent) were selected from 4 physical
therapy clinics in middle to low socioeconomic suburbs. Forty-seven of these people met the inclusion
criteria and were willing to take part in the study. The sole exclusion criterion was a poor command of the
English language that could impede understanding of the intervention information and the questionnaires.”
Punt 2: Interventie
Score: 1 punt
Toelichting:
“All subjects were prescribed the same progressive 3-phase physical therapy intervention protocol outlined in
Table 1, which was progressed on the basis of the severity of the sprain and their recovery from symptoms.”
“Clinic-based intervention. Subjects in this intervention group were scheduled appointments according to the
severity of their sprain, their rate of recovery, and their ultimate need for treatment. During these
appointments, the subjects undertook the physical therapy intervention program, with the physical therapist
spending time treating their symptoms and supervising the activities and exercises. Subjects also were
prescribed a small home program of no more than 4 simple activities, which was designed to supplement
the clinic treatment, not replace it. No standard written or verbal information was used to educate subjects
about their injury and physical therapy intervention. Instead, the physical therapists decided which educational
and cognitive behavioral techniques to use, and these techniques mostly depended on the severity of each
subject’s sprain, his or her rate of recovery, and his or her ability to understand and adhere to the treatment
program.”
“Home-based intervention. Subjects were scheduled clinic appointments that coincided with the transition from
one phase to another. During these appointments, minimal, if any, treatment of symptoms was given. Instead,
the physical therapists spent the time teaching the subjects about the application of the prescribed treatment
modalities to be undertaken at home during the next treatment phase and the indicators for progressing or
modifying them. To guard against the possibility of poor adherence that has been associated with home-based
physical therapy intervention programs, the subjects were given educational and cognitive-behavioral adjuncts
to help them implement the physical therapy intervention. These included a treatment booklet and equipment
such as strapping tape, Tubigrip* for compression, Thera-Band resistance bands,† and wobble boards. The
booklet contained information about the structure of the ankle; ankle sprains; the modalities for the 3
treatment phases and their method of progression; diary grids; progress sheets; and adherence-enhancing
strategies, such as cues, reminders, relapse prevention methods, and treatment goals. The information was
written in simple, everyday language, illustrated with pictures and diagrams, and it could be tailored to
suit the subjects’ rate of recovery. Subjects also were given pocket-size laminated cue cards as treatment
reminders and instructed to put the cue cards in noticeable places such as their pocket or bedside table.”
Score: 1 punt
Toelichting:
“Those who volunteered signed a consent form and were randomly assigned to either the clinic intervention
group or the home intervention group by way of a computer generated list.”
Punt 4: Blindering
Score: 1 punt
Opmerking: Blindering is voor deze uitkomstmaten niet belangrijk.
Toelichting:
Punt 5: Confounding
Score: 1 punt
Opmerking: Gegevens voor de interventie komen goed overeen.
Toelichting:
Score: 1 punt
Opmerking: Als uitkomst wordt gemeten hoe vaak de patiënten naar hun afspraken kwamen, hieruit
kan je opmaken dat de patiënten best trouw waren aan hun therapie. Er valt echter wel op dat de
thuisgroep zich thuis minder goed aan de leefregels/oefeningen houd dan de andere groep.
Als contaminatie kan je aanmerken dat alle patiënten op verschillende manieren gemotiveerd
worden en dat het aantal afspraken verschilt per persoon. Dit is echter wat zij al van plan waren te
onderzoeken.
Toelichting:
Score: 1 punten
Opmerking: Er wordt niks gezegd over andere interventies. Je kan echter wel uit de tekst opmaken
dat andere interventies niet toegestaan zijn.
Toelichting:
Score: 1punt
Toelichting:
“Demographic characteristics. The subjects’ age, sex, level of involvement in sports and physical activity,
and previous history of injury and physical therapy treatment were recorded. Distance from the clinic to home
(in kilometers) and reasons for choosing the clinic also were recorded. The ankle sprain characteristics assessed
were: (1) whether the injury was first-time or recurrent, (2) the date the injury was sustained, (3) the cause of
injury, and (4) the injury’s severity graded according to the O’Donoghue system. The level of pain at the time of
the injury was assessed using a box plot. An 11-point box plot was used in preference to a visual analog scale,
because we considered it to be more reliable for transposition of scores in the data entry phase of the study.”
“Ankle function. The Lower Limb Task Questionnaire (LLTQ)22 and the Motor Activity Scale measured ankle
function.”
“Adherence. Adherence was defined as the extent to which the subjects followed the clinic- and homebased
components of their physical therapy intervention. First, attendance at clinic appointments was measured by
the percentage of attendance (calculated by dividing the number of appointments attended by the number
scheduled and multiplying by 100). In addition, the number of subjects who completed their physical therapy
intervention program by attending their final scheduled clinic appointment was recorded.”
“Second, adherence to the physical therapy modalities given during the clinic appointment was assessed by
the physical therapists at the end of the treatment using the Sport Injury Rehabilitation Adherence Scale
(SIRAS).”
Score: 1 punt
Opmerking: Goed weergeven. 3 niet gekomen naar de afspraken na het beëindigen van het
programma.
Toelichting:
Voor volledig figuur zie artikel.
Score: 1 punt
Opmerking: Intention to treat analyse is gedaan.
Toelichting:
Zie figuur 1.
Score: 10 punten
CAT-analyse 6
A prospective, randomized clinical investigation of the treatment of First-time ankle
sprains. (Beynnon BD, Renström PA, Haugh L, Uh BS, Barker H).
Score: 1 punt
Toelichting:
“This was a community-based study of first-time ankle sprains in skeletally mature subjects who did not have
congenital deformity or degenerative conditions. Between April 1993 and June 1998, all subjects who had
sustained an ankle injury and visited the emergency departments of our 2 university affiliated hospitals, had
visited the university’s student health center, or were university athletes who had consulted trainers at the
university were invited to participate in this study. Subjects were included only if they presented to our clinic
within 72 hours after the initial ankle trauma. They were excluded if they had experienced or exhibited any of
the following conditions: had a previous sprain of either ankle; had abnormal gait before injury; had a previous
fracture in either ankle within the past 12 months; showed radiographic evidence of a fracture at the time of
presentation; showed radiographic evidence of a syndesmosis injury, burns, lacerations, or puncture wounds;
had open tibial epiphyses; were younger than 16 years or older than 65 years; were pregnant or planning on
becoming pregnant; had chronic illnesses, metabolic disease, or neurologic disease; or were unwilling to
adhere to the prescribed treatment program.”
Punt 2: Interventie
Score: 1 punt
Toelichting:
“Patients with a grade I ankle sprain were treated with an elastic wrap (Ace), Air-Stirrup ankle brace (Aircast,
Inc, Summit, NJ), or an Air-Stirrup ankle brace combined with an elastic wrap (Figure 1). Those with a grade II
sprain were treated with an elastic wrap, Air-Stirrup ankle brace, Air-Stirrup ankle brace combined with an
elastic wrap, or a fiberglass walking cast worn for 10 days followed by the use of an elastic wrap. Subjects with
a grade III ankle sprain were randomized to treatment with either the Air-Stirrup ankle brace or a fiberglass
walking cast worn for 10 days followed by the use of an elastic wrap.”
“Other than the before-mentioned treatment options, all subjects underwent the same care administered by the
same clinicians at the same clinic. All subjects followed the same standardized home rehabilitation program
that was provided through written instructions and oral directions. Rehabilitation involved 3 phases. Phase 1
occurred during the first week after the baseline visit. During this time, subjects were instructed to use crutches
as needed, perform swelling control with ice (eg, administer ice for 15-20 minutes, every 3-4 hours, for 72 hours
after injury), and elevate the injured ankle above heart level for 15 minutes every 3 to 4 hours during the first 72
hours after injury. Range of motion exercises were performed, including passive range of motion, Achilles
tendon stretching, and ankle circles. Subjects were allowed to begin with toe curl, ankle inversion, and ankle
eversion exercises with a towel and progress to swimming, walking, and riding a stationary bike when they
felt comfortable doing so. During phase 2, subjects initiated contrast treatments (eg, alternate use of heat,
followed by cold), and strength training progressed to isometric eversion, inversion, and dorsiflexion and
plantarflexion exercises. This was followed by dynamic exercises (heel and toe raises) and then single- and
double-leg balance training. Once the subject had completed phases 1 and 2, was pain free, and obtained full
range of motion, the subject progressed to phase 3. This involved agility drills (eg, directional walking,
jumping-hopping, and running activities), sport-specific drills, balance-board training, and elastic resistance
training with a Thera-Band. After the subjects’ strength had returned to normal, they continued with balance
exercises and gradual return to sports.”
Score: 1 punt
Toelichting:
“Subjects were then randomized to a treatment group according to the grade of the ankle sprain, sex, and age.”
“Treating clinicians and subjects were blinded to the randomization process, and the assigned treatment was
concealed within an envelope before allocation. A Block randomization procedure was used so that the
treatment schedule was arranged in blocks, with each block containing each treatment once. For example,
there were 4 treatment methods for grade II ankle sprains. Because we had 4 treatment methods and planned
to test a total of 80 subjects with this injury, there were 20 blocks. The first Block contained a random ordering
of the 4 treatment methods, the second block contained an independent random ordering of the 4 conditions,
and so on. Each random sequence of the 4 treatments obtained from a table of random numbers composed a
separate block.”
Punt 4: Blindering
Score: 0 punten
Opmerking: Patiënten, therapeuten en effectbeoordelaars waren niet geblindeerd.
Toelichting:
“Treating clinicians and subjects were blinded to the randomization process”
“One weakness of the study was that the treatment providers and study participants were not blinded to
assignment status after allocation because we were unable to conceal the specific external support the subject
was wearing. However, the primary and secondary outcomes were recorded by the patient via the daily logs
outside of the clinical setting, and therefore blinding of the physician to the treatments may have had little
influence on the measurement of these outcomes. It was not possible to blind subjects to the treatments they
received, and the effect this had on outcome remains unclear.”
Punt 5: Confounding
Score: 1 punt
Toelichting:
“The randomization procedure created a homogeneous sample of subjects. Subjects were of similar age, body
mass index, sex, and activity levels between treatments for each ankle sprain severity group (Tables 1 and 2).”
Score: 1 punt
Opmerking: Geen contaminatie voor zover bekend.
Score: 1 punt
Opmerking: Voor zover niet bekend dat er andere interventies toegestaan waren.
Score: 1 punt
Toelichting:
“Primary and Secondary Outcome Measures Baseline Through Day 21 or Until the Patient Healed:
At the baseline visit, subjects were given a daily log and instructed how to use it at home. The log contained
questions that the subjects answered by indicating their responses on a visual analog scale. Each day, the
subjects indicated their status with regard to return to walking a minimum of 1 block and climbing a minimum
of 1 flight of stairs in the same way they did before ankle injury, placingfull weight on the ankle without a limp
(primary outcome). They also documented their status with regard to tolerating full weightbearing,
experiencing no pain during weightbearing, achieving full capability in function of normal activities of daily
living, returning to full capability in work or school activity, and returning to full capability at usual athletic and
recreational physical activity (secondary outcomes). Thus, for each ankle sprain group (grades I, II, and III),
the log allowed us to measure the primary outcome (ie, the time required to return to walking a minimum of 1
block and climbing a minimum of 1 flight of stairs as was done before ankle injury, placing full weight on the
ankle without a limp) and secondary outcomes (ie, the time required for subjects to return to full weightbearing,
experience no pain during full weightbearing, obtain full capability in function at normal activities of daily living,
return to full capability in work or school activity, and return to full capability at usual athletic or recreational
physical activity). These primary and secondary outcomes were evaluated with the daily log for 21 consecutive
days after the baseline visit, and if necessary, this continued until the subjects could walk and climb stairs as
they did before the initial injury.”
“Patient Function and Ankle Motion: Tertiary Outcomes Obtained at 6-Month Follow-Ups
Patient function and ankle motion were evaluated at the baseline and 6-month follow-up visits. Measures
included demographic data, history of present ankle sprain (or reinjury at the 6-month follow-up), and
Karlsson’s functional scoring scale (an evaluation of pain, disability, and activity limitation).26 Plantarflexion
and dorsiflexion motion of the normal and injured ankles was evaluated with a handheld goniometer at the
baseline and 6-month follow-up visits. Dorsiflexion motion was evaluated relative to the neutral position with
the subject actively dorsiflexing the ankle and establishing the limit of motion, whereas plantarflexion
motion was measured relative to the same neutral position with subject actively plantar flexing the ankle to
establish the limit of motion. At the 6-month follow-up, the single-legged hop and toe raise tests were
performed. For the single-legged hop, subjects were instructed to jump and land as far as they felt comfortable
on their noninjured legs. Two jumps were attempted and the mean recorded. This was repeated on the
injured leg. Next, subjects stood on an inclined board and were instructed to perform toe raises by bearing
weight on their toes and elevating their heels to a maximum height. This was done individually on the injured
and uninjured ankles during 15-second intervals. The number of toe raises was recorded for injured and
uninjured limbs.”
Score: 0 punten
Opmerking: Aan het begin wel adequate follow up maar na 6 maanden niet meer.
Toelichting:
“For each ankle sprain severity grade, the primary and secondary outcome measures were obtained
from an adequate proportion of those enrolled (at least 80% were followed); however, a smaller proportion of
subjects participated in the 6-month follow-up. Capturing a larger proportion of those enrolled at the 6-month
follow-up may have produced statistically significant findings for some of the tertiary comparisons.”
Score: 1 punt
Opmerking: Er is sprake van een intention to treat
Toelichting:
“An intent-to-treat analysis was used. For the primary outcome of time required to return to normal (preinjury)
activity (ie, walking and stair climbing), we viewed the statistical tests of our hypotheses in a “survival analysis”
mode. Because it was possible that normal function was never achieved by a select subset of the treated
subjects, analysis of the data at the 6-month follow-up took into account the percentage of subjects not
completely cured. In addition, there were censored data because of subjects’ noncompliance with the study
protocol or the fact that some subjects moved away from the geographic area in which our study was
conducted. These data were handled by log-rank and other parametric likelihood methods. Event-time
distributions were estimated and displayed nonparametrically by the Kaplan-Meier method. Differences
between treatment groups were tested nonparametrically by log-rank tests. Alternative nonparametric tests
were done to confirm that the conclusions were robust to the methods used. Secondary outcomes were
analyzed in a similar manner. Karlsson’s functional scoring scale, ankle motion, and single-legged hop and toe
raise tests were treated as continuous data. Treatment group comparisons were performed with analysis of
variance and post hoc testing, although nonparametric rank tests were also performed to check that the
conclusions were robust to the data distribution assumptions.”
Score: 8 punten
CAT-analyse 7
Effect of neuromuscular electrical stimulation on ankle swelling in the early period after
ankle sprain. (Man IOW, Morrissey MC, Cywinski JK)
Score: 1 punt
Toelichting:
“Thirty-four subjects within the age range of 18 to 60 years with acute ankle sprain injury (occurring within 5
days of the first scheduled test) were recruited within 12 months from the Minor Injuries Unit, Guy’s Hospital,
London. Subjects who had a clinical diagnosis of a sprained ankle recorded in their medical notes were invited to
participate in the study. The severity of the ankle injury was not documented in the medical notes in the form of
any grading or classification system. Subjects with diabetes, peripheral vascular disease or any neurovascular
deficits or metal implants in the lower leg, injury to the contralateral ankle that required surgical attention in
the previous year, or open wounds and subjects who were taking diuretics or wore pacemakers were excluded
from the study.”
Punt 2: Interventie
Score: 1 punt
Toelichting:
“Four 10-cm-diameter Carbonflex disk electrodes* were applied to the lower leg muscles of the injured leg
of all subjects. They were made of conductive carbonized rubber and secured with a standard crepe bandage
to the subject’s lower leg with a water-soaked sponge separating the skin and the electrodes. Two electrodes
were placed over the muscle belly of the gastrocnemius muscle, and 2 electrodes were placed over the tibialis
anterior muscle of the injured limb. The sensations that would likely be felt were explained to the subjects
who were allocated to receive either NMES or submotor ES. For ES, the HEALTHFIT dual-channel P4-Microstim
stimulator† was used. The 2 electrodes on each muscle were connected to a separate channel of the stimulator.
The ES was characterized by a low-voltage, rectangular waveform having modulated patterns of frequency and
pulse duration (Fig. 2). The 30-minute ES pattern used for the subjects in the NMES and submotor ES groups had
a total of 360 cycles, with each cycle lasting 5 seconds. Each cycle consisted of 400 pulses having different
combinations of pulse-to-pulse intervals and duration values. The calculated average frequency of ES was
80 Hz, but the actual ES was delivered in packets (bursts) causing short-lasting muscle contractions every 1.25
seconds (0.8 Hz) for the subjects in the NMES group. During each burst, the pulse duration varied from 60 to 240
microseconds, and the pulse-to-pulse interval was 8 milliseconds (125 Hz).”
Score: 1 punt
Toelichting:
“Before arriving at the testing laboratory, subjects were randomly assigned, in groups of 3, to 1 of the 3 groups,
using a die protocol.”
Punt 4: Blindering
Score: 1 punt
Opmerking: Therapeuten en patiënten niet geblindeerd.
Toelichting:
“The 2 volume assessors were blinded to the group allocation of the subjects.”
“Disorders were measured by the volume assessors who were blinded to the treatment groups of the patients.”
Punt 5: Confounding
Score: 1 punt
Toelichting:
“The subject characteristics of the 3 groups at baseline are shown in Table 2. Height and injured and uninjured
ankle girth measurements were statistically different at baseline. The Tukey Honestly Significant Difference post
hoc analysis showed the difference to be between the sham ES and submotor ES groups. The characteristics of
each group for the other possible confounding variables are displayed in Table 1.”
Score: 0 punten
Opmerking: Er wordt niks gezegd over de therapietrouw. Echter is het wel zo dat de patiënten
andere behandelingen mogen (dit wordt namelijk bijgehouden), dit kan effect hebben op de
zwelling. De patiënten mogen namelijk gewoon ijzen.
Toelichting:
Zie punt 7.
Score: 1 punt
Opmerking: Er wordt bijgehouden wat voor andere behandelingen de patiënten nemen.
Toelichting:
“When subjects attended for their subsequent tests, they were asked several questions regarding
whether they had taken any more analgesics or anti-inflammatories and whether any other treatments (eg,
physical therapy, ice) had been applied to the ankle since the previous session.”
Score: 1 punt
Toelichting:
“The outcome measures used in this study were the pretreatment and posttreatment changes for: (1) mean
injured ankle volume, (2) mean swelling volume, (3) mean injured ankle girth, and (4) mean ankle girth
difference measured at each test session and adapted Hughston Clinic Subjective Rating Scale for Ankle
Disorders scores obtained during the first and third test sessions.”
Score: 1
Opmerking: Bij de resultaten vindt er geen verandering plaats in het aantal patiënten. Het kan echter
ook zo zijn dat dit is vanwege een intention to treat analyse. Ik denk eerder dat ze allemaal naar de
follow ups zijn geweest.
Toelichting:
Score: 0
Opmerking: Ik denk dat er een intention to treat analyse is.
Toelichting:
Score: 8 punten
CAT-analyse 8
Plyometric training versus resistive exercises after acute lateral ankle sprain. (Manal IM,
Mohamed IM)
Score: 1 punt
Toelichting:
“From June 2007 to January 2009, the primary researcher (M.M.) evaluated 42 consecutive athletes whom one
of four orthopedic surgeons diagnosed with lateral ankle sprain and referred to the outpatient physical therapy
clinic. Subjects who met the following inclusion criteria participated in the study: (1) grade I or II unilateral
inversion ankle sprain at least 3 weeks after the acute injury (based on the healing process of the ligament
since, the repair phase or the fibroblastic stage requires up to 3 weeks to maximize collagen content and hence
stress imposed on the ligament can result in a structurally stronger ligament through being subjected to
controlled strain in a functional pattern like that of plyometric training), (2) age between 20 to 35 years
(an epidemiological study6 revealed that most ankle sprains occurred in the 15- to 35-year-olds), (3) met the
prerequisites for plyometric training recommended by Tippett and Voight include:
 Positive power squat testing with a weight equal to 60 percent of the individual’s body weight
performed five times in 5 seconds.
 Ability to perform one-leg standing for 30 seconds with eyes open and closed before the initiation of
plyometric training.
 Ability to maintain static and dynamic control of body weight with single-leg squat.
Subjects were excluded from the study if they had acute inflammatory conditions, gross joint instability (grade 3
ankle sprain), concurrent ankle fractures with or without subluxation, dislocation or complete rupture, surgery
for ankle injury, recurrent ankle sprain, any anomaly of the foot, and history of chronic diseases or other injuries
of the lower limb.”
Punt 2: Interventie
Score: 1 punt
Toelichting:
“All participants received the same initial treatment for at least the first 3 weeks after injury. Initial treatment
incorporated local application of ice, elevation of the injured ankle, and rest. When the swelling and pain
disappeared, (usually after 3 to 5 days) early ankle mobilization, and early weightbearing were introduced.”
“A 6-week plyometric training program developed by Miller et al.23 according to the recommendations of Piper
and Erdmann29 for intensity and volume was used in this study. Instructions for each plyometric exercise were
given before the first treatment session. Training volume ranged from 90 to 140 foot contacts per session while
the intensity of the exercises was increased for 5 weeks before tapering off during week 6 as recommended by
Piper and Erdmann and others. The plyometric training group trained 2 days a week, throughout the study.
During training, all subjects were under direct supervision. The plyometric drill consisted of jumping and
hopping in different directions, with or without a barrier and with single or double leg stance (Table 1).”
“The resistive group was instructed not to start any type of plyometric training during the 6-week period of the
study. Resistive training was started in the form of manual resistive exercise for dorsiflexion, plantarflexion,
eversion and inversion (manual resistance was applied for 3 to 5 seconds for ten repetitions in each cardinal
plane). While controlling the time that a maximal contraction was maintained, the therapist was assured that
the targeted musculature was being maximally loaded. Resistance was applied to the dorsum of the foot
just above the toes to resist dorsiflexion and to the plantar surface of the foot at the metatarsals to resist
plantarflexion. For inversion, resistance was applied to the medial aspect of the first metatarsal and to the
lateral aspect of the fifth metatarsal to resist eversion. Active weightbearing exercises in the form of heel rise
and toe rise were performed for ten repetitions each. Towel curl and marble pick up was performed at the end
of the session for ten repetitions each. The subject placed the foot on a towel; then curled his/her toes, moving
the towel toward the body. For marble pick up, the subject was sitting and marbles placed to one side of the
patient’s foot. He picked up one marble at a time by curling his toes around it, then placed it in a container on
the other side of his foot. This emphasized the plantar muscles as well as inversion and eversion. The resistive
group was trained 2 days a week throughout the study.”
Score: 1 punt
Toelichting:
“The subjects were randomly assigned into two groups by a blinded and independent research assistant who
opened sealed envelopes that contained a computer generated randomization card.”
Punt 4: Blindering
Score: 1 punt
Opmerking: Therapeuten en patiënten kunnen niet geblindeerd zijn. De assessor is wel geblindeerd.
Toelichting:
“All measures were performed by the same assessor who was blinded to the training program.”
Punt 5: Confounding
Score: 1 punt
Toelichting:
“There was no significant difference between subjects in both groups concerning age, weight, height, gender,
and sport activities (p > 0.05).”
“There were no significant differences in all measures at baseline in both groups.”
Score: 0 punten
Opmerking: Best veel patiënten zijn gestopt tijdens de studie (therapietrouw). Daarnaast is het niet
bekend of de patiënten zich aan hun leefregels houden (m.n. in de eerste 3 weken) (contaminatie).
Toelichting:
“From the 19 allocated to the plyometric group, nine subjects left the study for personal reasons and ten
subjects continued the rehabilitation program.”
“A potential limitation of the current study may be that the number of subjects was relatively low. A larger
sample size would provide further insight into the efficacy of this training modality. With this sample size the
power of 80% was obtained concerning functional tests but a 20% increase in isokinetic measure could not be
reached.”
Score: 1 punten
Opmerking: Hier wordt niks over gezegd maar wij gaan ervan uit date r niks anders toegestaan was.
Dit is namelijk na 3 weken standaard behandeling. Normaal zouden zij al uitbehandeld zijn maar nu
gaan zij door.
Toelichting:
Score: 1 punt
Toelichting:
“Before and after the 6 weeks of the study period, each subject performed the four functional ankle tests (two
for muscle strength and endurance, one for balance, and one for functional stability) taken from the
performance test protocol and scoring scale for evaluation of ankle injuries of Kaikkonen et al. This scale was
recommended for studies evaluating functional recovery after ankle injury. These tests were selected because
(a) they reflected the functional stability, strength, endurance, and balance of the ankle joint needed to prevent
chronic ankle instability (b) focused on objective evaluation rather than subjective and (c) were simple to
perform. The first test was walking down a staircase to determine functional instability (evaluated using two
levels of a staircase with 42 steps; height, 17 cm; depth, 22 cm). The subject walked down once, 1 step at a time
with full contact of the sole to the stair. The walking time was recorded manually with a stopwatch. The second
test was rising onheel (subject was asked to rise on the heel with 1 leg as many times as possible at the pace of
60 times per minute to measure the fatigue of the ankle). The knee of the opposite side was flexed 90 degrees
and the arms were kept behind the back. In case of lost balance, the subject was allowed to touch the wall to
regain balance and then continue the performance. The third test was rising on the toes to measure the fatigue
of the plantarflexors. The fourth test was balance in a one-legged stance. The subject was asked to stand on
the forefoot on a square beam (height, 10 cm; width, 10 cm; length, 30 cm) with the knee of the opposite side
flexed 90 degrees and the arms kept behind the back. The time (seconds) standing was measured manually with
a stopwatch.”
Score: 0 punten
Opmerking: Veel patiënten zijn niet gekomen naar de follow-up afspraken.
Toelichting:
“From the 17 athletes assigned to the resistive group, five were lost at followup, two subjects changed their
address without notification, and three were involved in intensive resistive training in preparation for
competition.”
Score: 0 punten
Opmerking: Geen intention to treat.
Toelichting:
“To determine similarity between the groups at baseline, subject age, height, and body weight were compared
using independent t tests. Descriptive statistics on gender, and sport activities were compared using chi square
tests for homogeneity. Ankle isokinetic peak torque/body weight, the time needed to climb down stairs, the
repetitions of rising on heel, rising on toes and the duration of standing on one leg was analyzed using an
independent t test. Statistical significance was defined as p < 0.05. For statistical analyses, SPSS 13.0 software
was used.”
Score: 7 punten
CAT-analyse 9
Low-level laser treatment can reduce edema in second degree ankle sprains (Stergioulas
A.)
Score: 1 punt
Toelichting:
“Soccer players that were presented with lateral ankle sprainsbetween July 10, 1992 and May 20, 1998 to the
Sports Medicine Lab, University of Athens, who were between 18–26 years old and whose injury had occurred
earlier than 8 h, were selected.”
Punt 2: Interventie
Score: 1 punt
Toelichting:
“The first group (n = 16), the therapeutic protocol of which provided only for the conventional initial treatment
(RICE), the second group (n = 16) whose therapeutic protocol provided for the RICE method plus placebo
laser, and the third group (n = 15) whose therapeutic protocol provided for the RICE method plus an 820-nm
GaA1As diode laser, with a radiant power output of 40 mW at 16 Hz.”
“The treatment of all subjects began 2 h after the initial diagnosis of injury. The low-power galium-aluminiumarsenide laser (Biotherapy 2000, manufactured by Omega Universal Technologies) was used. This laser
operating with a single laser diode, was used for 5 min. Table 1 details the treatment parameters. Before laser
treatment was applied, the area was cleaned with alcohol. Ten points around the lateral side of the ankle
were irradiated.18 The first treatment took place in the morning (10:00 a.m.), and the second treatment in the
afternoon of the same day (6:00 p.m.). All three groups followed the same treatment schedule: two treatments
per day for three days. The laser set produced a sound and a red display to all patients. For protection from the
laser beam, all subjects wore glasses. Cold pressure pads (TRU 1042, PI Medical Comp., USA) were applied
on all subjects, three times a day for 20 min per application. During the application of the cold pressure pad, the
injured extremity was elevated, while throughout the rest of the day it was in an elastic wrap (PHN 7250,
Mueller Sports Med., Inc., USA), in accordance with Knight. The athletes were also advised not to put weight on
the lower extremity during the treatment period and to use crutches for their daily activities.”
Score: 1 punt
Toelichting:
“After the consent, 47 soccer players were randomly allocated to one of three groups.”
Punt 4: Blindering
Score: 1 punt
Toelichting:
“Soccer players, physiotherapists, outcome assessors and statistician, were blinded to the treatment given.”
Punt 5: Confounding
Score: 1 punt
Opmerking: Er wordt niks gezegd over baseline. Het is echter niet heel erg belangrijk aangezien er
wordt gekeken naar het verschil in zwelling.
Toelichting:
Score: 0 punten
Opmerking: Er wordt niks gezegd over therapietrouw. Het is zo dat veel gebeurd waar de
fysiotherapeuten bij zijn. Het is echter niet zeker of de patiënten thuis lopen met hun krukken en of
ze hun ‘elastic wrap’ omhouden.
Toelichting:
Score: 1 punt
Opmerking: Dit is niet aanwezig. Er wordt duidelijk uitgelegd wat er wordt gedaan per dag.
Toelichting:
Score: 1 punt
Toelichting:
“The edema was measured using the volume-measuring method that measures water displaced when the limb
was placed in a volumeter, which is made of Plexiglas and has an opening on top for the displaced water to
overflow. Many researchers have used this method to measure the edema of the upper extremities, as well as
the lower extremities. The reliability of this method has been pointed out by several researchers. The procedure
was as follows: The receptacle was filled with water until it stopped overflowing from the rim of the opening.
The athlete would sit on a chair at a distance of 25 cm from the volumeter, and place the injured lower
extremity in the volumeter very slowly—so as not to spill additional water during the submersion of the limb—
until the heel touched the bottom and the sole was in a neutral position. The displaced water was collected and
measured. Calculations were in milliliters. Water volumes recorded in the measurements following treatment,
were subtracted from the first measurement. The difference represented the change in volume of the foot
edema and the possible diminution of it.”
Score: 1 punt
Opmerking: Ze hebben het over 72 uur. Deze meting zullen ze niet veel later dan de laatste
behandeling hebben gedaan. In de tabel is er geen verandering in het aantal patiënten.
Toelichting:
Score: 1 punt
Opmerking: Ik denk dat er een intention to treat is, dit omdat alle patiënten zijn behandeld en er
geen één is gestopt.
Toelichting:
Score: 9 punten
CAT-Analyse 10
Effect of accelerated rehabilitation on function after ankle sprain:
randomised controlled trial (Bleakley CM, O’Connor SR, Tully MA, Rocke LG,
MacAuley DC, Bradbury I et al)
In/exclusiecriteria
Punt: 1
Toelichting: “Patients aged 16-65 years attending an accident and emergency department
(Royal Victoria Hospital, Belfast) or sports injury clinic (University of Ulster) were included if they had
an acute (<7 days) grade 1 or 2 ankle sprain. Two researchers (CMB, SRO’C) excluded patients if they
had a complete (grade 3) rupture of the ankle ligament (mechanical instability diagnosed by a
positive anterior drawer or inversion stress test), had a bony ankle injury (indicated by Ottawa ankle
rules or plain x ray films), had multiple injuries (for example, other joint injury or fracture), had a
contraindication to cryotherapy, were non-English speaking, were under the influence of drugs or
alcohol, or had an insufficient address for follow-up. Participants signed a letter of informed consent.”
Interventie
Punt: 1
Toelichting: “Both groups received written advice on applying ice and compression. Such treatment
followed a standard intermittent protocol and consisted of two 10 minute applications of ice and
compression interspersed with 10 minutes of rest (repeated three times daily for one week). In week 1
the exercise group undertook therapeutic exercises adapted from a standard protocol (see web
extra). The group received standardised verbal and written instructions and a DVD showing the
exercises. To monitor compliance with treatment and analgesic use participants completed a
treatment diary, which was returned to the research physiotherapists (SRO’C, CMB) at the first followup (week 1). External ankle support (including forms of taping, bracing, and bandaging) or analgesics
were not routinely provided. Treatment was standardised in both groups from weeks 1-4 and
consisted of ankle rehabilitation exercises focusing on muscle strengthening, neuromuscular training,
and sports specific functional exercises. The participants undertook these exercises for 30 minutes
each week, once under supervision from the research physiotherapist and four times as a home based
treatment. In our current study we used an exercise group that initiated rehabilitation exercises
during the first week of injury. The exercises were prescribed for 20 minutes, three times a day, and
focused on increasing ankle range of movement, activation and strengthening of ankle musculature,
and restoring normal sensorimotor control.
Randomisatie
Punt: 1
Toelichting: “We used a computer generated randomization sequence to randomise participants.
Group allocation was printed on a card (group 1 for standard care group. group 2 for exercise group),
and placed in sequentially numbered opaque envelopes with carbon paper on top (SMcD).
Randomisation was stratified according to athletic or non-athletic background. For each stratum we
produced separate block randomisation sequences using an allocation ratio of 1:1 and a block size of
4. After written consent had been obtained and baseline assessment, SRO’C and CMB randomised
participants to one of the two groups from the numbered envelopes.”
Blindering
Punt: 1
Toelichting:” A researcher (MAT) blinded to the intervention group recorded outcomes at weeks 1-4.”
De therapeuten en patiënten kunnen onmogelijk geblindeerd zijn tijdens deze studie.
Confounding
Punt: 1
Toelichting: In de tabel hieronder is te zien dat de groepen aan het begin redelijk gelijk zijn aan
elkaar.
Therapietrouw en contaminatie
Punt: 0 punten
Toelichting: Er worden huiswerkoefeningen meegegeven maar je kan natuurlijk nooit controleren of
deze ook daadwerkelijk worden uitgevoerd. Een ander discussiepunt is dat je niet weet of de
patiënten naast deze behandeling nog een andere behandeling volgen omdat hen geen restricties is
opgelegd met betrekking tot het uitvoeren van activiteiten. Er is natuurlijk geadviseerd maar je weet
niet in hoeverre de patiënten dit opvolgen.
Co-interventies
Punt: 1 punt
Toelichting: Er wordt niets gezegd over co-interventies. Elke patiënt krijgt volgens deze studie
dezelfde behandeling.
Uitkomstmeting
Punt: 1
Toelichting: “The primary outcome measure was subjective ankle function, assessed using the lower
extremity functional scale. The secondary outcome measures included pain at rest and with activity,
assessed using a 10 cm visual analogue scale; swelling, using a modified version of the figure of eight
method; and physical activity, using a professional physical activity logger. The sports ankle rating
score was completed at baseline and on completion of the study. This scale includes an objective
assessment of gait, joint range of movement, strength, mechanical stability, postural stability, and a
functional, single leg hop test. Self reported function was also assessed using the Karlsson score at
baseline, on completion of the study, and at the 16 week follow-up. Reinjury rates were recorded
during follow-up assessments at weeks 1-4 and at week 16.”
‘Loss-to-follow up’
Punt: 1
Toelichting: “In total, 101 met the inclusion criteria and were randomised to either the standard
group (n=51) or the exercise group (n=50). One participant in the standard group did not receive the
intervention as allocated. Fifteen participants dropped out during the trial. Figure 1 summarises the
recruitment, randomisation, and follow-up.”
“One participant from the standard group was excluded after randomisation when follow-up
radiography revealed a fracture.”
Data analyse
Punt: 1
Toelichting: “A constrained (as the trial is randomised we constrained the baseline means to equality)
linear mixed model analysis was undertaken based on intention to treat, using response variables of
lower extremity functional scale score, pain at rest, pain on activity, and swelling, and covariates of
treatment type (standard or exercise), time, and athletic background (athletic or non-athletic). We
calculated the difference between treatments (adjusted for baseline values) along with 98.75
confidence intervals at each time point (weeks 1-4). The level of significance was set at a Bonferroni
corrected level of 0.0125 (0.05/4).”
Totaal punten: 9
Cat-Analyse 11
Effect of unsupervied home based proprioceptive training on recurrences of
ankle sprain: randomised controlled trial (Hupperets MDW, Verhagen EA,
van Mechelen W)
In/exclusiecriteria
Punt: 1
Toelichting:
Interventie
Punt: 1
Toelichting:
De interventie is duidelijk beschreven: “The programme was derived from a previously described
programme, modified by two physical therapists to consist of more general exercises that were to be
carried out individually. Feasibility was tested in a pilot study. A detailed description of the
different basic exercises of the proprioceptive training programme is described elsewhere, and the
training programme is in the appendix on bmj.com. The programme prescribed three training
sessions a week, with a maximum duration of 30 minutes a session. Athletes were encouraged to
perform the exercises as part of their normal warm up. Exercises gradually increased in difficulty and
training load during the eight week programme. Athletes in the intervention group received a balance
board (Avanco AB, Sweden), exercise sheets, and an instructional DVD showing all exercises of the
programme. All information was also provided on a website, accessible only for those in the
intervention group.”
Randomisatie
Punt: 1
Toelichting:
Er is sprake van randomisatie: “Athletes were randomised to intervention or control, with
stratification for sex, type of enrolment, and usual care of ankle sprain.Astatistician who had no
knowledge regarding any other characteristics of the participants performed the randomisation.”
Blindering
Punt: 1
Toelichting:
Punt toegekend omdat de effectbeoordelaar geblindeerd is. Het is onmogelijk voor de therapeut en
de patiënt om geblindeerd te zijn.
“On the basis of the completed injury registration forms, a physical therapist and the primary
researcher, who were blinded to group allocation, independently rated all registered ankle injuries as
acute lateral ankle sprains or other ankle injuries.”
Confounding
Punt: 1
Toelichting:
De groepen zijn redelijk vergelijkbaar aan het begin van het onderzoek:
Punt: 0
Toelichting:
De therapie is niet door iedereen toegepast. Ook is er “missing data”, de vragenlijst is namelijk door
34 sporters niet ingevuld.
“A total of 58 (23%) athletes in the intervention group said they had fully complied with the eight
week proprioceptive training programme; 75 (29%) said they had been partially compliant; 89 (35%)
were classified as not compliant. Compliance with the training programme was unknown for 34 (13%)
athletes as they did not complete the questionnaires. Five out of 266 in the control group (2%) said
they had performed some sort of proprioceptive training exercises during the one year follow-up.
These athletes performed proprioceptive training exercises as part of medical treatment of a
recurrence of ankle sprain and were not incorporated in the analysis.”
Co-interventies
Punt: 0
Toelichting:
Deze studie is niet onder supervisie uitgevoerd. Er is wel verteld wat de patiënten wel en niet mogen
doen maar er kan niet gecontroleerd worden of dit ook daadwerkelijk is gebeurd.
Uitkomstmeting
Punt: 1
Toelichting:
Er is om de maand gekeken naar het opnieuw optreden van enkelletsel hiervoor is een vragenlijst
gebruikt.
Punt: 1
Toelichting:
De loss-to-follow up is geregistreerd.
Data analyse
Punt: 1
Toelichting:
De gerandomiseerde toewijzing van de patiënten aan een van de groepen is gerespecteerd gebleven
bij het analyseren van de onderzoeksresultaten.
“All statistical analyses were undertaken according to a pre-specified plan. Injury incidences and
corresponding 95% confidence intervals were calculated for total sports participation as the number
of recurrent ankle sprains reported per 1000 hours of sports, with exposure
time of each individual player until the first recurrent ankle sprain. We also carried out a subgroup
analysis on medical care for the inclusion ankle sprain.
Cox regression analysis compared risk of recurrence of ankle sprain between the groups, with
adjustment for age, type of sport (contact or non-contact), and level of sports (competitive or
recreational). Other variables were checked for confounding or interaction, but none was found. All
analyses were carried out according to the intention to treat principle. Differences were considered
significant at P<0.05. Compliance numbers were presented as the absolute number of athletes (and
percentages) in each category. Athletes in the control group who performed some form of
proprioceptive training during followup were presented as a total number and a percentage of the
total number of athletes in that group.”
Totaal: 8 punten
CAT-analyse 12
Randomized controlled study of ultrasound therapy in the management of acute lateral
ligament sprains of the ankle joint (Nyanzi CS, Langridge J, Heyworth RC, Mani R)
Score: 1 punt
Opmerking: Geen gradatie in enkelletsel aangegeven voor inclusie.
Toelichting:
“All patients with inversion injuries of the ankle presenting consecutively to the A&E department at
this centre were examined before having an x-ray of the injured ankle to exclude fractures, and
admitted to the study if they met the following criteria.”
“Patients included had sustained injuries less than 100 hours prior to entry, were able to follow
instructions, and were in the age range 14–65 years. Subjects were excluded from the study if
they had a previous similar injury within 1 year, had sustained multiple injuries, were diabetic,
had extensive varicose veins or had bony injuries rendering them unstable.”
Punt 2: Interventie
Score: 1 punt
Toelichting:
“A treatment intensity of 0.25 W / c m2 at a mark space ratio of 1:4 at 3 MHz was used. Treatment
time was set at 10 minutes per session which allowed each area to be insonated for 2 minutes.
An ultrasonic coupling gel recommended by the manufacturers was used. In practice, this gel was
applied liberally to the skin under treatment with the transducer head held at right-angles to it.
The head was moved in small overlapping circles to cover the area, taking care to keep the head
in contact with skin all the time. Treatment was given on three consecutive days and patients
were asked to attend a follow-up clinic 14 days after the last session.”
Score: 1 punt
Toelichting:
“A randomized controlled study was carried out with patients assigned to either ultrasound therapy
or placebo using a randomization code from the local department of Medical Statistics and
Computing.”
Punt 4: Blindering
Score: 1 punt
Opmerking: Patiënten + therapeuten geblindeerd.
Toelichting:
“Neither the user (CSN) nor the patient was aware of whether the ultrasound machine was in its
active or sham phases.”
Punt 5: Confounding
Score: 1 punt
Toelichting:
“Between groups, no statistically significant differences were measured in any of the objective
measures.”
Score: 0 punten
Opmerking: Er staat aangegeven hoeveel er niet meer zijn gekomen naar de behandelingen. Dit is
echter wel 12,1%.
Contaminatie = Er wordt niet bijgehouden hoeveel paracetamol er wordt ingenomen per patiënt. Dit
kan erg verschillen en is wel van belang bij de VAS uitkomstmaat. Daarnaast wordt er in de discussie
getwijfeld aan de blindering.
Toelichting:
“Seven patients (12.1%, 4 placebo group and 3 ultrasound group) failed to complete the study by
not attending either the third or the final session. On enquiry, all of these reported that they had
recovered fully and did not have the time to attend the study.”
Score: 1 punt
Opmerking: Er wordt niet aangegeven hoeveel paracetamol er wordt gegeven.
Toelichting:
“Patients were advised to elevate the affected limb while resting, and weight bear on the injured
foot when they were active. All patients were given suitably sized Tubigrip® (Seton, UK) to
wear after treatment. Paracetamol was prescribed for those in need of analgesics.”
Score: 1 punt
Toelichting:
“Since pain, swelling and reduced mobility are major clinical features of ankle sprains, the outcome
measures chosen to ascertain the effects of treatment were: a 10-cm linear visual analogue
score (VAS) to assess pain, tape measurement of the ankle to determine swelling (Figure 2), range
of ankle movement (ROM) to assess mobility, and simultaneous weighing on two identical bathroom
scales with one foot on each to assess ability to weight bear. Both dorsiflexion and plantar flexion
were recorded using a fluid – filled goniometer to determine ROM. All assessments were done by the
same investigator (CSN) at all visits. Before recording VAS scores, patients were asked to walk a fixed
10-metre distance on all occasions.”
Score: 0 punten
Opmerking: Aangegeven hoeveel er niet naar de laatste sessie zijn gegaan. Deze nemen ze niet mee
in de data-analyse i.v.m. het niet hebben van gegevens.
Toelichting: Zie therapietrouw
Score: 0 punten
Opmerking: Er wordt alleen beschreven van hoeveel patiënten de data-analyse is gedaan. Nergens in
het artikel staat beschreven hoe ze dit hebben gedaan.
Score: 7 punten
CAT-Analyse 13
Supervised exercises for adults with acute lateral ankle sprain: a
randomized controlled trial (van Rijn RM, van Os AG, Kleinrensink GJ,
Bernsen RM, Verhaar JA et al)
In/exclusiecriteria
Punt: 1
Toelichting: “Patients with a lateral ankle sprain were eligible for the study if they were aged between
18 and 60 years and their first visit to the physician was within 1 week of injury.
Patients were excluded if they had a history of an injury of the same ankle during the previous 2 years
or if they had a fracture of the same ankle”.
Interventie
Punt: 1
Toelichting: “Patients in the physical therapy group participated in an individual and progressive
training programme supervised by a physiotherapist, using a standardised
protocol, which was based on guidance from the Royal Dutch Society of Physiotherapists
(Supplementary Table 1). This programme existed of a maximum of nine half-hour sessions, within a
period of 3 months, and included balance exercises, walking, running, and jumping”.
Randomisatie
Punt: 1
Toelichting: “After informed consent and after acquiring baseline information (questionnaire and
clinical findings), each patient was randomised by a blinded and independent research assistant,
making use of sealed envelopes which contained computergenerated randomisation cards, into either
the conventional treatment group or the physical therapy group. Randomisation was stratified for
setting (general practice versus emergency department) and severity of the injury (grade I and grade
II versus grade III) with a block size of six”.
Blindering
Punt: 1
Toelichting: “All participants in both groups received the same conventional treatment from their
physician who was not aware of whether the patient undertook additional supervised exercises”.
Confounding
Punt: 1
Toelichting: “Potential confounders were age, sex, body mass index, injury grade, treatment received
as preferred, ankle load during work, and ankle load during leisure time at baseline”.
Punt: 0
Toelichting: “All patients in both groups received instructions on home exercises as part of the
conventional treatment at the initial examination. In the group with additional supervised exercises,
74% (n = 28) of the patients reported to have done their home exercises regularly. Most patients in
the group with conventional treatment alone (82%; n = 36) reported that in the first 3 weeks after
injury they rarely or never did their home
exercises”.
Co-interventies
Punt: 0
Toelichtig: “As some participants did not receive the treatment as initially allocated or crossed over
and visited a physiotherapist during the trial, the treatment received
was not 100%as initially allocated. Those who did not receive the physical therapy as allocated (n = 4)
never attended the physical therapy practice. Of the patients
assigned to the group with conventional treatment alone, 11% (n = 6) crossed over and visited a
physiotherapist during follow up (all within the 3 months’ follow-up period)”.
Uitkomstmeting
Punt: 1
Toelichting: “The primary outcome measures were subjective recovery and occurrence of re-sprains at
3 months and 1 year of follow-up. Secondary outcome measures were patients appreciation of the
received treatment, tested and reported instability and range of motion (ROM) of the ankle joint at 3
months’ follow-up, and reported instability at 1 year of follow-up. Questionnaires were administered
at baseline at 4 weeks, 8 weeks, 3 months, and 1 year after injury. Information was asked about:
subjective recovery on a 0–10 point scale (0 represents no recovery and 10 full recovery); re-sprain;
the patient’s appreciation of the received treatment (no, partial, or full appreciation); and reported
instability”.
Punt: 1
Toelichting: “A total of 107 patients were randomised during the inclusion period. Five of these
patients (three from the physical therapy group, two from the conventional
treatment group) were randomised too early. Although they reported to have sent the baseline
questionnaire at the time they were randomised, researchers never received it; therefore, these five
patients could not be included in the analyses. During the trial another five patients (four from the
physical therapy group, one from the conventional treatment group) were lost to follow-up, but their
last available data were carried forward in the analyses”.
Data analyse
Punt: 1
Toelichting: “Data were analysed with researchers being unaware of participants’ group assignment,
using both an intention-to-treat analysis and a per-protocol analysis
(that is, analysis based only on patients who complete the entire treatment protocol). For patients
with incomplete datasets or who were lost to follow-up, the last available data were carried
forward”.
Totaal punten: 8

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