Manual Acupuncture, Electroacupuncture and

Manual Acupuncture, Electroacupuncture and
Electroauriculotherapy Treatments for Acute
Cervical Disc Herniation: A pilot clinical trial.
Submitted in partial fulfillment of the requirements for the
Doctor of Acupuncture and Oriental Medicine Degree
Oregon College of Oriental Medicine
Hilda Cavalla MTOM, LAc, Dipl OM
June 2009
1
Acknowledgements
I would like to thank Dr. Tim Chapman Ph.D for his mentorship and for his expert
help with biostatistics. I would like thank Dr. Richard Hammerschlag, Ph.D
for his mentorship and expert feedback in this project. I would also like
to thank Dr. William Kelly D.C for his mentorship and guidance in my career.
I would like to express my appreciation to the faculty and staff at Oregon College
of Oriental Medicine Doctoral Program for their leadership and professionalism.
Finally, I would like thank my husband, Dr. Michael Cavalla D.C for his help in this
project and for his love, and support.
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Table of Contents
Abstract
5
Specific Aims
6
Introduction
7
Background and Rationale
8
Research/Literature Review
14
Objectives
24
Significance
25
Material and Methods
26
Outcome Measures
32
Results Chart
33
Table 1. Baseline Demographics
33
Table 2. Percent Improvement
34
Figure 1: Change in ROM
35
Figure 2. Change in Oswestry
36
Results
37
Discussion
38
Conclusion
44
Risk
45
References
46
3
Oswestry Graph Electroacupuncture
Appendex 1
Oswestry Graph Manual Acupuncture
Appendex 2
Oswestry Graph Electroauriculotherapy
Appendex 3
ROM Graph Electroacupuncture
Appendex 4
ROM Graph Manual Acupuncture
Appendex 5
ROM Graph Electroauriculotherapy
Appendex 6
Oswestry Questionnaire
Appendex 7
4
Manual Acupuncture, Electroacupuncture, and Electroauriculotherapy
Treatments for Acute Cervical Disc Herniation: A pilot clinical trial
Abstract:
The pilot study investigates the outcome of manual acupuncture,
electroacupuncture, and electroauriculotherapy for the condition of
acute cervical disc herniation. Decompression therapy was used in all groups.
Forty eight patients were randomly selected for manual acupuncture,
electroacupuncture and electroauriculotherapy over a period of two years.
Treatments were given by a single acupuncturist and consisted of a course of 12
sessions, one per week for each patient. The treatment outcome was measured
by Oswestry questionnaire and ROM measured by an inclinometer
before and at last sessions. Forty eight patients were evaluated and all
had successful outcomes. The success rate was higher in the electroacupuncture group with 29 % improvement measured by Oswestry
questionnaire, the ROM also had the best outcome with 23%
improvement. The second best outcome was the manual acupuncture
with 27% improvement with Oswestry and ROM measured 21%.
Electroauriculotherapy was third best and showed 20 % for Oswestry
5
and 17 % improvement for the ROM. The results indicated that
electroacupuncture is the most effective treatment for selected
patients with acute disc herniation condition.
Principal Investigator: Hilda Cavalla, MTOM, L.Ac, Dipl OM
Specific Aims:
The overall goal of this pilot clinical trial study is to compare effectiveness of
Manual Acupuncture, ElectroAcupuncture and Electro- Auriculotherapy in
treating an acute cervical disc herniations. Each technique will be evaluated in
regards to pain reduction, increased functional scale and mobility. Decompression
therapy was applied to all the groups.
 Compare the Effectiveness of adjunctive of Manual Acupuncture,
Electroacupuncture, and Electroauriculotherapy treatments in two years
of case reports from my private practice.
 Assess pain reduction, by relieving the spasm, and accelerating healing at
the site of injury as an outcome measure.
6
Introduction
Disc herniations are physiological changes in the intervertebral discs, due to
biomechanical changes in the nucleus pulposus, which lessen the water binding
capability in the disc. If the herniated nucleus compresses or irritates the nerve
root, there may be sudden, severe, or insidious pain, numbness and eventually
muscle weakness (Yochum et al, 1987). In addition to neck pain, patients often
have referred pain in areas such as: shoulder, or head the latter presenting as,
interscapular, suboccipital and occipital headaches(Dillin et al, 1985).Cervical
radiculopathy refers to the signs and symptoms that result from nerve root
compression in the neck. A patient may also have a nerve root compression and
only experience neck pain with no radiculopathy. This study will include both
types of patients with these signs and symptoms. This type of neck condition is
less common than lumbar disc herniations. The common spinal sites of disc injury
are at the C6/C7 or C5/C6 levels. These levels are most in danger because of
higher intersegmental mobility.(Yochum et, al, 1987)
7
Background and Rationale
Standard Medical Treatment of Acute Disc Herniation
In initial period of acute cervical disc herniation, non operative care is the
standard. This includes immobilization with a soft collar, anti-inflammatory drugs
and non narcotic analgesic medications in the acute phase (Fitz-Ritson et
al,1988). Other therapies include traction, manipulation, trigger point injections,
exercise and transcutaneous electrical nerve stimulation (Dillin et al, 1985).
Physical agents such as ice, moist heat and ultra sound are also used. Patient
education as to posture, lifting mechanics and isometric cervical exercise are
recommended when the pain has diminished (Boden et al, 1989).
Acupuncture Treatment of Acute Disc Herniation
In Traditional Chinese Medicine the condition of acute disc herniation is
considered to be a Painful Obstruction syndrome. The painful obstruction
syndrome is also called “bi” syndrome which means blockage. This syndrome
indicates pain, soreness or numbness of muscles, tendons and joints caused by
exterior invasion and root organ pathologies. In Chinese medicine, the blockage
can occur from the lack of circulation of qi and blood in the channels caused by
invasions of exterior wind, cold or dampness. An accident causes either
stagnation of qi or blood or both in a region. The person may recover perfectly
8
well after an accident but some stagnation may remain in the area from the
accident. The exposure to external pathogenic factors can lead to Painful
obstruction syndrome in that area. This explains the unilateral development
where the climatic factors of wind, cold and dampness settle in the area due to
the pre-existing condition of stagnation from the accident (Maciocia et al, 1994).
TCM Causes of Disc Herniation(Maciocia et al,1994):
1. The general deficiency of qi and blood causes the immune system of the body
to be compromised, which allows for the invasion of exterior pathogens.
2. Organ pathology is from the deficiency of liver and kidney which leads to
malnourishment of sinews and bones. This condition causes aches and
stiffness. It also allows for the settling of phlegm in the joints.
3. Formation of phlegm in the joints is due to improper transformation of
body fluids. This condition has an underlying spleen deficiency because there
is an impairment of the transportation of body fluids.
4. Stasis of blood causes stiffness and pain due to lack of circulation and
nourishment in the sinews.
The Summary of 5 types of Painful Obstruction Syndrome(Maciocia et al,
1994):
 Wind Painful Obstruction Syndrome: pain moving from joint to joint.
 Damp Painful Obstruction Syndrome: fixed pain with heaviness,
9
soreness, numbness and swelling of the joints.
 Cold Painful Obstruction Syndrome: Severe pain in one joint.
 Heat Painful Obstruction Syndrome: very severe pain, hot red swollen
joints.
 Bony Painful Obstruction Syndrome: painful joints with swelling and bone
deformities.
Electroauriculotherapy Treatment of Acute Cervical Disc Herniation
Electroauriculotherapy is defined as an electrical stimulation administered on the
auricle of the external ear. This type of therapeutic stimulation is used to treat
health conditions in other areas of the body by using ear acupuncture points. The
ear acupuncture points and all systems of acupuncture began in ancient china.
This classic information was documented in the original Chinese medical text, The
Yellow Emperor’s Classic of Internal Medicine, compiled in 500 BC. In this text, the
ancient ear acupuncture points were not organized, but instead were scattered in
an arrangement of non meridian location. In the ancient text, of Yellow Emperor’s
Classic of Internal Medicine all six yang meridians are said to directly connect to
the auricle. In contrast, all six yin meridians are indirectly connected to the ear,
through the relationship of their corresponding yang meridian.(Oleson et al,1996)
10
In modern Europe, Dr. Paul Nogier in 1957, was one of the pioneers of
auriculotherapy in France. He developed a somatotopic map of the ear,
based on the principle of the inverted fetus orientation. The inverted fetus
orientation creates a similarity between the brain map and auricular map. Dr.
Nogier’s next discovery was the use of therapeutic electrical micro-current to
treat pain relief in the body using ear reflex zones.
The neurological basis of auriculotherapy is on the gate theory which was
developed by Melzak and Wall in 1965. The theory talks about the spinal cord
having inhibitory inter-neurons that react differentially to A fibers and C fibers.
The activation of inhibitory neurons in the spinal cord will suppress the pain. The
A fibers are fast conducting. They carry information about touch and suppress the
experience of pain. If the A fiber activation is high the initial pain stage will have a
partially closed gate which means the diminishing of pain. The C fibers are slow
and carry information about the conscious experience of pain and light touch.
Auriculotherapy produces analgesia by suppressing the pain by activation of the A
fibers. It does not elicit de qi stimulation. The body acupuncture creates de qi
stimulation and activates the C fibers. Auriculotherapy should provide faster
pain relief, because of the activation of A fibers than body acupuncture which
uses slower conducting C fibers pain relief. (Oleson et al, 1996)
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The Treatment of ElectroAcupuncture
The electrical stimulator is attached to the needles proximal to the site of pain.
The electro-acupuncture also uses the neurological system of pain control based
on the gate theory. The electrical stimulation activates the A fibers, which are the
faster reacting fibers towards pain. The high frequency currents are those
electrical currents that can stimulate a patient at a frequency of 1000 pulse per
second. This current is used to exercise muscle after injury, develop muscle
strength and tone, alleviate pain, trigger chemical changes and break muscle
spasm.(Jaskoviak et al, 1986) There are two types of low frequency current
utilized: direct current (galvanic) and alternating current. The mechanism of
action is determined by the wave form and frequency utilized. In this study
alternating current with a low frequency of 15 Hz was used on the subjects. The
alternating current has a continual change in the flow electrons. One end of the
electrode is negative and other is positive and then the polarity is reversed. The
electrons move in one direction along their charged pathway and then changes
direction. This happens in one cycle and then the frequency of the current is the
number of cycles per unit of time. The use of electricity to treat pain seems
modern, but actually it has a long history reported in the west as early as the first
century, when electric torpedo fish were used to treat gout.(Kendall et al,2002)
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Decompression Therapy
Physical medicine was developed by the ancient Chinese and is grouped into
three categories: pressure, massage and manipulation.(Kendall et al, 2002).
Manipulation therapies include controlled or practitioner guided movement of
the extremities, head, neck, and spine. The purpose of manipulation is to remove
obstructions in the superficial vessels, improve circulation of blood and relax
muscles. Manipulation therapy such as decompression therapy was used to
lubricate the joints, reduce swelling, alleviate pain, restore normal joint function,
enlarge joint spaces, relieve nerve compression and reduce adhesions.(Kendall et
al, 2002).
Decompression therapy applied in this study is a manual type of traction. This
type of traction is an intermittent mechanical unit of applied stretches to the
muscle and spine with periods of relaxation.(Jaskoviak et al, 1986)
The major effects of intermittent spinal traction are:
 Increases in lymphatic drainage and vascular flow caused by the pumping
action from the traction.
 Increases muscles tone and restores elasticity and resiliency.
 Stretching of adhesions and fibrotic tissue increase muscle mobility.
 Promotion of IVD hydration resulting from an alternating pulls and
13
relaxation periods, creating a pumping of the disc.
 The stimulation of proprioceptive reflexes.
Axially distraction to the cervical spine was applied to all the subjects.
Research/Literature Review
Patients with chronic neck pain are using acupuncture and transcutaneous
electrical nerve stimulation for pain relief. This study is based at a pain clinic
focused on acupuncture in neck pain management. The (Smith 2000) used an
Oxford Pain Validilty Scale but the only valid reviews highlighted were of negative
outcomes. The evidence that existed was demonstrated as a variety of outcomes
such as: sleep improvement, improved mobility, reduced general practitioner
visits and reduction of medication.
The Wengraf (2004) study used acupuncture, TENS unit, traction, heat/cold,
massage, manipulation, hydrotherapy and ultrasound. All patients reported pain
relief, improved sleep, relaxation, and mobility of neck and shoulder. The patients
that were treated felt understood by their physiotherapist. In this study, it was
hard to ascertain if the connection with their therapist played a role in the overall
effectiveness of the treatments.
14
Ulett (1997) article refers to electroacupuncture as being more effective in
pain relief than manual acupuncture. The low frequency of 2Hz and high
frequency 100Hz of electroacupuncture induces the release of enkephalins and
dynorphins, respectively, in both experimental animal and humans. In studying of
experimental pain in human volunteers, needles alone provided some pain relief.
Addition of electricity was added to the needles this made the treatment 100%
more effective. The Chinese surgeons added electricity to their needles when
they wanted strong analgesia for surgical procedures.
Han (1981) suggested the importance of endogenous opiod substances in
mediating acupuncture analgesia in a cross tolerance experiement.
Electroacupuncture was applied to rats at Zusanli and Sanyinjiao points for six
sessions using alternating 2-15Hz with .3ms duration for 30 minutes session with
30 minute intervals. The repeated electroacupuncture resulted in tolerance which
was a gradual decrease of acupuncture effect. A dose of morphine at (6mg/kg, IV)
was administered to rats also induced tolerance following injections of
morphine at (5-50mg/kg, 3 X a day for 8 days). The effects of morphine returned
to control levels 9 days after morphine treatments. The electroacupuncture
analgesia had a similar attenuation. These findings suggest that electroacupuncture analgesia and morphine analgesia share the same or similar
mechanism (Han et al, 1981).
15
Fei (1986) examined the selectivity of electroacupuncture on endorphin release
in CSF at different frequencies. The study used rats and artificial CSF injected into
the spinal subarachnoid space before and after electroacupuncture at Zusanli
and Sanyinjiao points using 2, 15 or 100 Hz. The CSF fluid was then collected and
measured. The methionin enkephalin, dynorphin A, or dynorphin B
neurotransmitters were then measured using radioimmunoassay. The methionin
enkephalin and dynorphin were preferentially released into CSF by electroacupuncture at low and high frequencies, respectively.
Chen (1983) divided rats into three groups according to the degree of analgesia
produced by electroacupuncture (15 Hz, 3V for 30min). They tested the effects of
electroacupuncture which induced an increase in the tail flick latency. The brain
was then removed for the measurement of the cerebral B endorphin
immunoreactivity with radioimmunoassay. The results showed a change in the B
endorphins with high analgesic effects and no change in B endorphins with a low
analgesic effect.
Wang (1992) conducted a study in rats that compared the analgesic
effect of three types of stimulation: manual acupuncture, electroacupuncture and
TENS. The results showed a greater analgesic effect with electroacupuncture than
manual acupuncture.
16
Similar analgesic effects of electroacupuncture and transcutaneous electric nerve
stimulation were found at frequencies of 2Hz, 15 Hz and 100 Hz.
White (2004) compared acupuncture with a placebo treatment for chronic neck
pain. The neck pain was caused by degenerative changes such cervical spondylosis
and osteoarthritis. The study included 124 patients in a randomized, single
blinded, controlled trial. The pain in both groups was decreased by similar
amounts of 12%.
Witt (2006) assess acupuncture for patients with chronic neck pain. The study
was a randomized controlled trial plus a non-randomized cohort. The randomized
group of 1880 patients received acupuncture immediately. The non-randomized
group of 10, 395 patients acupuncture immediately. The sham control group of
1886 patient also received delayed acupuncture treatment three months after.
The primary objective was to investigate the effectiveness of acupuncture in
addition to routine care in patients. The needle technique was manual stimulation
only. The kind of routine care was not stated. The non- randomized group showed
a disability improvement compared to the randomized group. The nonrandomized patients had more severe symptoms at the baseline with higher neck
pain. The randomized group proved to be superior to the sham control group with
its delayed acupuncture treatment. The randomized group with its immediate
acupuncture treatment displayed a superior reduction of neck pain and disability.
17
It also improved physical and mental functioning.
The pilot study conducted by Samuels (2000) used subjects with acute torticollis
Eighteen patients received 20 minute acupuncture treatment session,
with needling of two acupuncture points SI3 and Luo Zhen, on the side of pain.
They used a single compass and protractor to measure the angle of lateral head
rotation, before and after treatments. There was improvement of 52.9% with
patients treated less than 24 hours post injury. There was less of an improvement
72 hours following injury.
Blossfedt (2004) investigated the outcome of acupuncture for chronic neck pain.
Of 172 patients evaluated 68% had a successful outcome from acupuncture.
The success rate of pain relief was 50%. The success rate percentage was higher in
patients with a short duration of pain. The patients with three months of pain
improved 85%. Patients with pain up to six months improved 78%. The patients
with longer term injury showed up to 49% relief. The acupuncture treatments
were not standardized but customized to the individual. The core points were
GV20, LV3 and Hua To Da Ji: along the paravertebral (1 cun lateral to spinous
process) along the cervical and upper thoracic spine from C2 to T3. Some other
points added are Gb21, SJ 15, SI14, trigger points along the trapezius and levator
scapula. The needles were retained for 15 to 30 minutes with neither manual or
electrical stimulation.
18
The controlled trial conducted by Zhu (2001) was a single blinded, crossover,
clinical trial. Twenty nine patients were randomly recruited into two groups.
Individualized acupuncture treatments consisted of nine sessions on both
local and distal points. Manual twisting of needles was applied on all points plus
strong electrical stimulation at distal points. The sham acupoints were (lateral to
the real points) weak electrical stimulation of 15 to 25 Hz was applied. The
objective measures consisted of neck range of motion and pain threshold. The
real and sham treatment groups both showed significant reduction of subjective
pain without difference between groups. The objective measures showed an
improvement with no significant change for either group.
Garvey(1991) discusses, conservative care for cervical radiculopathy. This
orthopedic surgeon states that therapies such as traction and trigger point
injections should be used in the earlier treatment. He also recommends the use of
a soft collar for immobilization, and physical agents like (ice, moist heat and ultra
sound).
Eliyahu(1989) focuses on disc herniations of cervical spine. This chiropractor
suggests that patients with disc herniations with symptoms of pain of a radicular
nature should use conservative care such as traction, physiotherapy, massage and
gentle manipulation if tolerable. This literature suggests several weeks to several
months of care. He recommends diagnostic monitoring with anatomical and
19
neuro-physiological testing to initially document the extent of injury and to
assess clinical progress.
The article by Durinjan, addresses the physiology of the auricular reflex therapy,
based on the distribution of nerve endings on the ear and their cranial nerve
innervations throughout the body. The conchae of the ear is innervated by
cranial nerve VII, IX and X.(Durinjan et al, 1980) The triangular fossa and the
conchae are analogous in their innervations. The difference lies on their
topography. The conchae is the region of reflex responses to the function of the
thoracic and abdominal organs. The triangular fossa is the region of reflex
response to pelvic organs. He describes the triangular fossa as innervated by the
trigeminal nerve V, which is not present in the conchae. The trigeminal nerve
produces a powerful thalamocortical activation.
Simmons and Oleson (1993) assesses whether auricular electrical stimulation can
elevate toothpain threshold and if the effects can be reversed by opioid
antagonist naloxone. The study randomized 40 subjects into four groups. ( 1st) AES
therapy followed by saline,( 2nd ) AES therapy followed by naloxone,( 3rd ) placebo
AES therapy followed by saline, (4th ) placebo AES followed by naloxone. The AES
groups showed a statistical significant 18 % elevation of pain threshold. The two
placebo groups were essentially unchanged. The mean pain threshold increased
by more than 23% for the group with AES and saline, but fell to less than 12% for
20
the subjects in the groups of naxolone & AES. These findings show a pain
threshold elevation by AES that is partially blocked by naxolone indicating.
Naxolone reversed the elevations of dental pain threshold. This outcome suggests
that auricular electrical stimulation analgesia uses endogenous opioid system as
one mechanism for pain relief. The outcome was that acute pain threshold was
elevated by the stimulation of auricular acupuncture points and the tooth pain
was reduced.(Simmons et al 1993)
A study Oleson and Kroening (1983) on electro-acupuncture and auricle electrical
stimulation, compared the clinical effectiveness of these two therapies. The
therapies involve an endogenous pain inhibitory system that includes both
endorphin and non-endorphin systems. Both somatic and auricular acupuncture
points show a reduced skin resistance at the site of pathology, which exists on the
same side of the body. The authors claim because of this finding electroacupuncture and auriculo-therapy can be used for treatments and diagnosis of
medical conditions. The authors based their theory on studies conducted by
Pomeranz, Chapman, Reichmanis and Ledergergber. Dr. Pomeranz was the first to
provide indirect evidence for involvement of the endorphin system in
electroacupuncture. When he used naxolone and electroacupuncture on mice
the pain relief effect remained at baseline and no analgesic effect was found. The
analgesic effect was found with AES followed by saline. Dr. Chapman’s study
reveals a partial reversal of electro- acupuncture analgesia by naxolone for relief
21
of pain. The investigation by Reichmanis, utilizes a wheel electrode in a circuit
with DC. This wheel is rolled over the skin areas and shows that acupuncture
points have lower skin resistance. The Ledergergber’s research, found that lower
frequencies 6-10Hz are effective for mild pain such as that related to arthritic
pain. The higher frequencies of 800-1000 Hz were more effective for severe pain
such as trigeminal pain.(Noling et al, 1986)
An article on new nomenclature for identifying Chinese and Nogier auricular
acupuncture points (Oleson and Kroening, 1983) evaluates the differences in the
somatotopic representations of certain body areas, which are markedly different
in these two ear acupuncture systems, although both systems share the inverted
fetus pattern on the ear. The authors pointed out that the auricular points of
lower back, the leg, the heart and the kidney are in different locations in the
Chinese chart and Nogier’s chart. Both systems are described as valid in the
efficacy of auricular treatment and diagnosis because they are attached to the
sensory and motor peripheral nerve conduction to the brain.
The article by Noling, (1986) examined a group of 40 healthy subjects and applied
acupuncture like tens to auricular points for wrist pain. The wrist pain threshold
statistically increased. The chronaxie meter is used to determine the subject’s
experimental pain threshold at the wrist. An electro-stimulator was used to
stimulate the auricular points of (wrist, shen men, lung and dermis). The result
22
suggests that an increase in pain threshold achieved after the electro-stimulator
was applied on the auricular points cannot be totally attributed to a placebo
effect or pain induced stress. The results showed an analgesic effect that
increased with the passage of 5 to 10 minutes after the treatment.
An article by Lapeer and Gerard (1986) focusing on auriculotherapy and dentistry,
describes the use of an instrument called a punctoscope-diascope to locate
pathological acupoints by looking for a decreased electrical resistance points on
the ear. Tender points were located and needled with stainless steel ten minutes.
If gold or silver needles were used, no stimulation was required. After the
treatment a semi-permanent steel needle was administered.
Kroening and Oleson (1985) studied a rapid narcotic detoxification in chronic pain
patients who are treated with auricular electro-acupuncture and naloxone. The
subjects were given auricular acupuncture to reduce withdrawl symptoms during
opiate detoxification. Bilateral electrical stimulation at 125Hz was applied to
needles inserted in the Lung and Shen Men points of the same ear. The daily dose
of methadone was cut in half from previous day’s level. On the last day of
treatment no methadone was given, and the patient received a naloxone to
determine susceptibility to withdrawal symptoms. Twelve of the patients( 85%)
were completely withdrawn from narcotics medications with in 2-7 days and they
experienced no or to minimal side effects. The usual detoxification time is 3-6
23
months.
The next study, from the Texas Medical Center in Houston, examined
auriculotherapy as the newest treatment method for pain control for chronic
conditions such as cancer. The electro stimulation with the probe was
administered to patients with cancer and the intensity level of pain and
description of pain improved. (Burtoft et al, 1989).
Manual Acupuncture, Electroacupuncture and Electroauriculotherapy in the
treatment of acute cervical disc herniation.
Objectives:
1. The comparison of the three therapies of: acupuncture, auriculotherapy
(electrical stimulation on ear), and electroacupuncture(electrical
stimulation device) attached to the acupuncture needles. The study is to
determine, which of these therapies are most effective in the treatment of
acute neck disorder.
2. Decompression therapy was used to anatomically remove obstructions
from the cervical disc.
24
Significance
Acute disc herniations, are common and major cause of pain, physical
limitation and loss of work time. Neck pain affects 51% of the adult
population, with acute cervical disc disease a strong predilection among
individuals who lift heavy objects, smoke cigarette, dive, operate
vibrating equipment and ride in cars.(McPhee et al, 2008).Though, this type of
acute neck pain occurs mostly in the laborer community it is not uncommon to
see this condition in the normal population, such as people: who work with
computers, lift groceries and do everyday activities. The economic cost from lost
of wages and work time is estimated to exceed 30 billion dollars and is expected
to increase over the next few years. The accepted general approaches to treat
acute cervical disc herniations are the use of soft collar and anti-inflammatory
agents. Although over the counter anti-flammatory drugs are a major treatment
approach for this condition, a 1997 study, estimated 3300 deaths of patients 65
years and over due to this type of OTC medication. Surgery is the next approach,
the fusion of the discs or anterior cervical discectomy, is performed with mixed
results.(Boden et al, 1989). The use of alternative therapies such as acupuncture
and decompression therapy allow the patient and more natural form antiinflammatory effects.(Eliyahu et al, 1989). These therapies are a non-evasive, safe
and effective answer to pain relief with out the side effects of medication the
trauma of surgery. The therapies being studied in the present clinical trial are
traditional acupuncture, auricular electrical stimulation and electrical stimulation
25
attached to needles at site of injury. Decompression therapy to remove the nerve
root impingement by opening the nerve root canal and freeing the nerve root, will
be provided in all three groups as a standard method. These symptoms of
cervical radiculopathy such as of pain down the arm or down the back will be
relieved. The symptoms of stiffness of neck and persistent neck pain may be
alleviated.(Dillin et al, 1985)
Materials and Methods
Participants & Design
The study included 48 participants who came into my private office with MRI
Reports of cervical disc herniation along with symptoms of neck pain,
radiculopathy down arm or interscapular pain. The subjects signed a consent form
that included information about risks associated with any of the acupuncture
treatments. Patients were randomly assigned to three study groups by the office
manager. Each patient completed standardized Oswestry questionnaire on the
first and last visits to assess their levels of neck pain and functional. The patient
was tested with physical examination of passive and active ranges of motion on
the first and last visits. The inclinometer was used to measure the ROM on first
and last visits to determine the level of changes in the condition.
26
Study Population:
Inclusion Criteria:
1. Presenting complaint of neck pain and /or radiculopathy.
2. MRI or X ray report of history of cervical disc herniations.
3. 20-50 years of age.
4. Neck pain less than three months duration.
Exclusion Criteria:
1. Neck pain caused by degenerative disc disease.
2. Corticoid steroid therapy
3. Prior surgery on neck
4. Neck pain caused by autoimmune disease, malignant tumors and viruses.
5. Cardiac pacemakers.
6. Chronic neck pain (spondylolishesis, spondylolysis or spinal stenosis).
7. Other complementary therapies- chiropractic, massage, exercise & yoga.
8. Use of analgesic medications.
9. Congenital deformation of spine, exception is slight lordosis or scoliosis.
10. Compression fractures.
11. Pregnancy.
12. Prior experience to acupuncture.
27
Treatment Protocols:
Acupuncture Treatment
Acupuncture treatment was provided by the investigator (HC), a licensed
acupuncturist with 8 years of experience in pain management and sport
medicine cases. The subjects received a total of 12 treatments, one per week for
12 weeks. The neck and upper shoulders were treated bilaterally. The
acupuncture points were standardized and a selection of ashi points, were chosen
based on which points were tender on palpation. The following points in the
neck, head and shoulders were taken from a cohort study conducted by Blossfeldt
(2004).
1. Hua Tuo Jia ji points on the paravertebral points (1cm lateral to the spinous
process) along the cervical spine and upper thoracics from C2-T2.
2. GB 20, Gb21, and SJ 15, SI 13- SI15.
3. Ashi points were chosen on the occiput & trapezius areas.
Prior to insertion the needle sites were swabbed with alcohol. The depth of
needle insertion was superficially on the neck and shoulder. The needles were
inserted to the depth of 0.5 -1.0 in the cervical and twisted gently till de qi
sensation arrived. The points of GB 20, GB21, SJ 15 were needled to a depth of
(0.3-.05), SI 13 was needled to a depth of 0.5 and SI 14 was needled to a depth of
0.7-1.0. Disposable Serin needles were used with guided tubes. The acupuncture
needles were 0.22mm in diameter, 13mm in length for neck and 40mm in length
for shoulder. The needles were kept in place for 30 minutes with patients resting
28
prone on the treatment table in a body cushion with dimmed lights and relaxing
music. The patient is also covered with a space blanket for warmth.
Electroacupuncture
The electroacupuncture treatments used the same acupuncture points as in the
manual acupuncture groups. The frequency of electrical stimulation and
treatment time was taken from the Zhu protocol. (Zhu et al, 2001). The Blossfeldt
article did not include frequency of electrical stimulation. The electrostimulator
(Pantheon) was attached to the needles in the following areas: the paravertebral
points one cun lateral to spinous process along the cervical spine from C2- T2.
The two pairs of micro clip electrodes were attached to these local points. The
needles were inserted about 5- 10mm depending on the location and size of
person. Neck points received electrical stimulation. The needles were
stimulated at a frequency of 15 Hz with an alternating pulse. The intensity of the
electrical stimulator was adjusted to the patient’s tolerance. The intensity of the
current remains below the sensory threshold. The period of stimulation was 20
minutes each session. During treatment the patient rests on a body cushion in a
prone position with dimmed light and soft music.
29
Electroauriculotherapy
Acupressure massage was first administered on the auricle by stroking broad
areas with thumb and fingers. The ear is cleaned with alcohol to eliminate skin oil
and residue. In this method, the stimulation on each ear point was administered
with a Stimflex 400 with a hand held electrical probe using microcurrent
stimulation at different frequencies. The probe was used to detect points of low
resistance or high conductance and to treat these points. The following points
used were the local anatomical points corresponding to the specific body
symptom. The most tender points and most electrically conductive
points were treated. Then master points were added to intensify the treatment.
The auricular points are from Olseon’s protocol.(Olseon et al, 1996)
1. The local anatomical points corresponding to symptoms are C2-C7 located
on the concha side of the antihelix tail. C7 lies above the concha ridge.
Function: cervical spine points to treat neck pain and torticollis. These points
are treated at 10 Hz frequency for 1 minute.
2. Thoracic spine points were used for upper back pain and for cases of
radiculopathy pain down the arm. T1-T3 points were used if tender. This point
is located above the concha ridge across from point zero. Function: relieves
upper back pain, shoulder pain. These points were treated at 10 Hz for 1
minute.
3. The Neck point was used for anterior neck muscles & scalene muscles. It is
located on the scaphoid fossa side of the antihelix tail. Function: relieves neck
30
tension, pain and torticollis. These points were treated at 10 hz frequency for 1
minute.
4. The Master Shoulder point was used to relieve pain from the scapula,
trapezius muscles and Chinese clavicle. Location is found in the inferior
scaphoid fossa, inferior to the shoulder point. This point was treated with a 10
Hz frequency for 1 minute.
5. The Muscle Relaxation point, is used to relieve muscle spasm and
Tension, is found on the peripheral inferior concha, near Chinese
spleen point. This point is stimulated at a 5 Hz for 1minute.
6. The master point used was the Thalamus point which is used for pain
control. It reduces pain by activating the thalamic gate of the supra spinal pain
inhibitory system, found on at the base of the concha wall which lies
behind the antitragus. This point is stimulated at 10 Hz for 1 minute.
7. The Shen Men master point is chosen for tranquility of the mind, to alleviate
stress, pain and tension. This point is stimulated at 10 Hz for 1 minute.
8. The Apex of ear point, stimulated to reduce inflammation and swelling
from acute pain, located on the top of the superior helix. The point was
stimulated at 10 Hz for 1 minute.
The ear points were treated bilaterally. The patient’s were treated in supine
position with soft music playing in the background.
31
Outcome Measures
One subjective and one objective measures were used in this study.
1. The Oswestry Disability Index Questionnaire used on the first and last
visits. The Oswestry is a validated, self administered health status instruments
for patients with neck or lower back pain. It assesses two dimensions of pain, the
intensity, and disability. The questionnaire is an extremely important tool that
researchers and disability evaluators use to measure the patient’s permanent or
temporary functional disability. This test has been in use for twenty five years
and is considered to be the gold standard for functional outcome tools. The
instrument describes the typical pain and limitation within the last week or two.
There are ten activities each on a scale from 0 (no pain) to 5 (cannot do
activities and experiences pain all the time). Ten activities are related to
neck characteristics, including personal care, reading, headaches, lifting,
concentrating, ability to work, sleeping, and driving. The patient scores are added
up and the points are divided by 50, and then multiplied by 100 to get the percent
disability.
2. Range of motion(ROM) an objective outcome was assessed in six
movements of the neck, involving flexion, extension, rotation, and
bending to both left and right sides. The inclinometer was used to measure the
degrees of neck ranges on the initial visit condition and the last visit. The change
between the two visits shows the improvement of the neck condition.
The patient’s were not given any additional follow up after the last appointment.
32
Results
Table 1. Baseline Demographics and Health Status by treatment groups.
Characteristic
Patients
48
ElectroAcup
N=16
Age, mean (SD)
# Women % baseline mean
Acupunctur
N=16
N=16
32
11(69)
Auricula
37
10(63)
34
8(50)
Oswestry, baseline, Mean
40
39
40
ROM, % baseline, Mean
42
40
42
Mean / Oswestry: T-Test
29
27
20
23
16.06445
8.341663
21
7.536577
5.905238
17
10.69579
8.027284
-2.14
-2.14
Mean/ROM: T-Test
Oswestry/ T-Test/SD
ROM/ T-Test/SD
Oswestry/T-Test/T value difference
Oswestry /T-Test/T value difference
1.948
Oswestry/T-Test/T value difference
0.541
ROM/T-Test/T value difference
1.948
0.541
-2.108
-2.108
ROM/T-Test/T value difference
ROM/T-Test/T value difference
1.646
-0.783
-0.783
Oswestry/T-test/DF
26
Oswestry/T-test/DF
26
Oswestry/T-Test/DF
21
ROM/T-Test/Degree of Freedom
29
ROM/T-Test/Degree of Freedom
27
21
29
27
27
0.041
Oswestry/ T-Test/P value
0.589
ROM/T-Test/ P value
0.043
ROM/T-Test/ P value
ROM/T-Test/ P value
27
0.041
0.063
Oswestry/ T-Test/P value
26
26
ROM/T-Test/Degree of Freedom
Oswestry/ T-Test/P value
1.646
0.063
0.589
0.043
0.108
0.440
0.108
0.440
33
Table 2. Percent Improvement in Oswestry & ROM
Groups
A
B
29
27
23
21
C
% Improved
Oswestry
20
% Improved
ROM
17_______
A=ElectroAcupuncture, B= Manual Acupuncture, C= Electroauriculotherapy
34
Figure 1. Change in ROM in Groups A B and C:
%
I
m
p
r
o
v
e
d
25
20
15
10
5
R
O
M
0
35
Figure 2. Change in Oswestry in Groups A, B, and C:
%
30
I
m
p
r
o
v
e
m
e
n
t
25
20
15
10
O
s
w
e
s
t
r
y
5
0
36
Results :
Pain characteristics and functional disabilities were similar in all three groups at
the baseline period. (Table 1) The comparison between groups A,B and C showed
similar scores in most areas, including age, pain duration and pain sites. The
Oswestry findings for the Electroacupuncture group showed a 29 % improvement
at follow up, compared to an average 27% improvement in the Manual
Acupuncture group, and an average of 20 % improvement in the
Electroauriculotherapy group. T-Tests showed that the observed improvement in
Oswestry scores for the Electroacupuncture group was significantly better than
for the Electroauriculotherapy group (29% vs. 20%; t= - 2.14, df =26, p =.041) The
difference between the Manual Acupuncture group and the
Electroauriculotherapy group was “borderline” significant (27% vs. 20%; t=1.948,
df=26, p=.063). The difference between the Electroacupuncture group and the
Manual Acupuncture group was not statistically significant (29% vs. 27%; t=54,
df=21, p=. 588). The ROM findings for the Electroacupuncture group showed an
average of 23% improvement at follow up, compared to an average 21%
improvement in the Manual Acupuncture group, and an average 17%
improvement in the Electroauriculotherapy group. T-Tests showed that the
observed improvement in the ROM scores for Electroacupuncture group was
significantly better than for the Electroauriculotherapy group (23% vs. 17%; t=2.108, df= 29, p=0.0434). The p value of 0.0434 showed to be statistically
37
significant between these two groups. The difference between the Manual
Acupuncture group and Electroauriculotherapy group was not statistically
significant (21% vs. 17%; t=1.646, df=27, p=.1083). The p value of 0.1083, shows a
“trend” a repetitive occurrence which is not significant. The difference between
the Electroacupuncture group and Manual Acupuncture group was not
statistically significant (23% vs. 21%; t=- 0.783, df=27, p=0.4407).
Discussion:
According to the results, the Electroacupuncture group had the best outcome in
ROM with 23% improvement and Oswestry with 29% improvements. The
electrostimulation in low frequencies of 15 Hz, may have enhanced therapeutic
effects in the target body tissue by increasing blood and lymph flow in the muscle.
The Manual Acupuncture group had close second finding with 21% improvement
in ROM and 27% improvement Oswestry. The manual acupuncture group used
natural electrical conductivity of acupuncture point and acupuncture needle to
thermocouple stimulation in the site of injury. The Oswestry score in the
Electroauriculotherapy group showed an improvement of 20% the least effective
in all three methods. The low electroauriculotherapy findings may have occurred
due its noninvasive method of no needle insertion. It is possible that the most
effective treatment protocol is in the site of pain instead of a distal stimulation on
the surface of the ear. The condition of acute disc herniation may require
treatment in the site of pain for increased effectiveness in pain reduction.
38
Pain is a universal experience with a normal continual protective mechanism of
the body in response to noxious stimulation.(Fitz- Ritson et al 1988) Pain is
subjective and has different manifestations in different people. One patient may
be silent in severe pain, while another person reacts to same pain with tears that
are disproportionate to the injury. The Oswestry questionnaire is the best
subjective assessment, but there is variability individually in the rating of pain.
This method could easily be interpreted to fit each person’s opinion on pain. This
personal interpretation can inaccurately influence the scores evaluated in this
study.
The Electroacupuncture and Manual Acupuncture groups showed similar
effectiveness in pain relief and mobility. The Starwynn states, that microcurrent
stimulation increases ATP concentrations in the cells and this can promote muscle
softening. In theory the microcurrent stimulation increases Qi flow in the area,
freeing up available energy and promoting ease of movement. Some studies
show, that microcurrent stimulation can reduce pain during exercise and increase
range of motion with less resistance. The electrical effects of manual acupuncture
was studied by Dr. Nordenstrom who observed, a potential difference between
the subcutis of the patient and acupuncturist fingers. He claims a form of
capactive flow of current, depending on strength of acupuncturist and patient’s
personal energy field. Periodic manipulation and twirling of needles can also
influence an electrical flow of charge. (Starwynn et al, 1999)
Electroauriculotherapy method was the least effective with ROM and pain
39
reduction. The electrical stimulation at the auricular points seemed effective for
pain relief, but the mobility of the neck was compromised. The groups with
needle insertion at the region of pain achieved greater increase in ROM and pain
reduction. The closeness of in T-test finding, ROM and Oswestry implies that my
sample size of 48 subjects was not large enough to determine if the difference is
significant.
The Electroacupuncture and Acupuncture methods seemed to get the best
results in pain reduction, anti-inflammatory response and relaxation of muscle
spasms. These two groups displayed an accelerated healing of discs, joint capsules
and associated structures. The cervical muscles affected were: splenius capitis,
splenius cervicis, iliocostalis cervicis, longissimus capitis, longissimus cervicis,
spinalis capitis, spinalis cervicis, semispinalis capitis, semispinalis cervicis,
interspinalis cervicis, intertransversarii, and the rotators cervicis muscles. (Tortora
et al, 1996).
Electroauriculotherapy follows the microsystem theory, which is different from
the traditional Chinese system of meridians. The theory does not follow meridian
pathways. The ear points appear to be related functionally to the area of the body
they represent. The neurological basis of auriculotherapy follows the “Gate
Control Theory” which produces analgesia by suppressing the pain activated by
the A fibers. The A fibers suppress the pain message experienced by the C fibers.
According to this theory, electrical stimulation of midbrain periaqueductal gray
can activate pain inhibitory pathway.(Olseon et al, 1996) No “De Qi” stimulation is
40
produced in microsystems. Dr. Abbate, discovered direct evidence of
endorphinergic basis of auriculotherapy. The increase of plasma B endorphin
concentrations were observed in subjects undergoing surgery observed after ear
acupuncture stimulation. The auricular points follow the utilization of the inverted
fetus map for electrical stimulation of lowered skin surface resistance.(Noling et
al, 1986). Only localized regions of the ear needing treatment will exhibit reduced
skin resistance and are electrically stimulated. The mechanism involves an
endogenous pain inhibitory system that includes both endorphin and nonendorphin systems.
Manual Acupuncture is speculated to follow the western philosophy of Gate
Control Theory for pain inhibition by using slow reacting C fibers. The gate theory
is defined as the nociceptive pain signals carried by small axons are blocked by
electrical stimulation induced impulses transmitted by large nerve fibers of the
same spinal segment.(Zhou et al, 2008). The primary mechanism for the clinical
effectiveness of acupuncture seems to also involve an endogenous pain
inhibitory system that is endorphin and non-endorphin. Acupuncture analgesia
releases neurotransmitters that are both inhibitory and excitatory. The de qi
stimulation is produced in this treatment method. The body acupuncture is a
macro-system that follows energy pathways. The theory of meridians is the 12
channels are connected internally to zang-fu organs and externally to extremities.
All the acupoints belong to different meridians, all the meridians are related to
41
certain zang- fu organs.
Musculoskeletal problems are often viewed as obstructive (bi), and flaccid (wei)
syndromes. Injury, trauma, and physical strain are other sources of pain and
dysfunction, which often led to wei disorder. (Kendall et al, 2002) The wei
syndromes involve flaccid conditions, atrophy of muscle tissue, injuries to
muscles, pain, including neurogenic pain.(Kendall et al, 2002) These two
syndromes are influenced by environmental factors and internal organ conditions.
In Chinese theory, the kidney organ is considered to have influence on the bones,
tendons and ligaments attached to the bones.(Kendall et al, 2002).The bladder
channel transverses the muscles and tendons and is thought to have influence on
them. The liver organ has a dominant effect on the muscles, tendons, and joint
ligaments. The spleen pancreas helps supply nutrients to the muscle tissue, by
balancing the uptake of glucose in the muscle cells, as controlled by insulin.
(Kendall et al, 2002).
Eastern view of the analgesic function of acupuncture has two categories:
regulate Qi & Blood and restore the Qi. The regulation of qi and blood follows
the pattern of removing the obstruction to allow smooth flow of Qi through the
channels. The restoration of Qi refers to the release and constriction of
tissues.(Connor et al, 1980) The restoring of the qi pattern means to strengthen
the body’s power of resistance by draining the excess and supplementing the
deficient.(Connor et al, 1980) The smooth flow of qi and blood allows the
nourishment of the yin and yang.
42
The Electroacupuncture method showed the best outcome, because it uses a
combination of methods such as the gate theory, Voll’s theory of microcurrent
therapy and Chinese meridian theory. This procedure is often used with profound
analgesia and is desired, for surgical analgesia. This method is employed in
treating nerve dysfunction, paralysis, and substance abuse withdrawl.(Starwynn
et al, 2003).
Voll’s microcurrent therapy encourages spasmolysis and tonification of
smooth muscles by increasing arterial and venous blood flow in the
vessel.(Starwynn et al, 2003). It reduces the inflammation by decreasing
exudative processes and accelerating healing. The degenerative processes is
reduced by promoting normal fluid transfer in and between cells. This function
encourages normal functioning of the connective tissue and fascia. The
microcurrent restores the polarization in the nerves, by maintaining ionic
equilibrium between the cells interior and interstitial fluids. The levels of ATP in
the muscular cells may be increased, facilitating muscle relaxation and increases
available energy. The patient experiences less pain and stiffness, this therapy
provides greater the range of motion. The microcurrent stimulation increases
circulation of Qi and Blood through the region of injury and reduces energetic
blockage. The low level of current used in this study, enhances the process of
proprioception.(Starwynn et al, 2003).
43
Conclusion:
The Electroacupuncture group showed the overall best outcome with range of
motion, pain reduction and functional ability, for the treatment of acute cervical
discs disorder. The manual acupuncture group had the second best results in the
study. The electro-auriculotherapy was not as effective possibly, because this
method did not use needles and treatment was distal from the site of pain. The
method of electroacupuncture is reported to stimulate the A and C fibers most
effectively in the site of pain, while manual acupuncture only activated C fibers in
the site of pain. The electroauriculotherapy activated A and C fibers distally from
the site of injury and was not as effective as the other two treatment therapies.
Further studies, on different frequencies of electrical stimulation need to be
explored and tested distally and locally from site of pain for efficacy. The
different voltages need to be explored for the effectiveness of A and C fiber
stimulation in both local site and auricular sites. The different durations of
treatment in all three modalities should also be explored for efficacy. Electroacupuncture and Manual Acupuncture showed the best results in alleviating pain
and accelerating healing in these cases. Decompression therapy was used in all
three groups because, clinically it is necessary to remove the obstructions from
neck for the treatment of this condition to be effective. Acupuncture treatments
were administered to past cases without traction therapy and the results were
limited. Electro auriculotherapy showed a trend toward healing and pain
reduction. More studies on gate control and acupuncture should be studied on a
44
larger scale for patients with acute cervical disc herniation.
Risks:
Acupuncture, Electroacupuncure and Electroauriculotherapy are safe methods of
treatment. The electrical methods are contraindicated for patients who are
pregnant and have pace makers. Sudden dizziness, nausea or fainting symptoms
may occur during acupuncture treatment with needles. Strict antisepsis is
necessary to avoid infection of the auricle. Ear acupuncture is not advisable for
women during pregnancy.(Cheng et al, 1987).
Benefits:
Acupuncture, Electroacupuncture and Electroauriculotherapy all three therapies
showed improvement of pain threshold with increase of functional scale. All three
groups are noninvasive and cost effective in comparison to conservative
medicine.
45
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50
Appendix 1
Oswestry Graphs ElectroAcupuncture:
60%
50%
40%
% IMPROVED
OSWESTRY
ELECTROACUPUNCTUR
30%
20%
10%
0%
1
2
3
4
5
6
7
8
9
10 11 12 13 14 15 16
NUMBER OF PATIENTS
51
Appendix 2
Oswestry Graph Manual Acupuncture:
40%
35%
% IMPROVED
OSWESTRY
MANUAL
ACUPUNCTURE
30%
25%
20%
15%
10%
5%
0%
1
2
3
4
5
6
7
8
9
10 11 12 13 14 15 16
NUMBER OF PATIENTS
52
Appendex 3
Oswestry Graph Electroauriculotherapy:
40%
35%
30%
% IMPROVED
OSWESTRY
ELECTROAURICULAR
25%
20%
15%
10%
5%
0%
1
2
3
4
5
6
7
8
9 10 11 12 13 14 15 16
NUMBER OF PATIENTS
53
Appendex 4
ROM Graphs Electroacupuncture:
40%
35%
30%
25%
% IMPROVED
ROM ELECTRO- 20%
ACUPUNCTURE
15%
10%
5%
0%
1
2
3
4
5
6
7
8
9 10 11 12 13 14 15 16
NUMBER OF PATIENTS
54
Appendex 5
ROM Graph Manual Acupuncture:
35.00%
30.00%
25.00%
% IMPROVED
ROM MANUAL
ACUPUNCTURE
20.00%
15.00%
10.00%
5.00%
0.00%
1
2
3
4
5
6
7
8
9 10 11 12 13 14 15 16
NUMBER OF PATIENTS
55
Appendex 6
ROM Graph Electroauriculotherapy:
30%
25%
20%
% IMPROVED
ROM ELECTRO
AURICULAR
15%
10%
5%
0%
1
2
3
4
5
6
7
8
9 10 11 12 13 14 15 16
NUMBER OF PATIENTS
56
Appendex 7
57