RESEARCH
Review Article
Is acupuncture effective for the treatment of common chronic musculoskeletal disorders?: A Review of Positive Randomized Controlled Trials
Author:
Richard Anthony Esquivel, L.Ac., MTCM
Editors: Bill Wright, L.Ac., MTCM & Eric Meyer-Reed, L.Ac.,
MTCM
Abstract
Objective:
To consider and review the evidence for the support of acupuncture as
a clinically effective treatment for common chronic musculoskeletal disorders.
Methods: Medline was searched for English language trials of acupuncture
or electroacupuncture of common chronic musculoskeletal disorders based
on the following criteria: 1) randomization 2) controlled trial (with
the control consisting of one of the following: no treatment, treatment
as usual, placebo, sham acupuncture, or active control) 3) experimental
treatment consisting of either acupuncture (in which acupuncture points
were stimulated by needle insertion) or electroacupuncture (in which electrical
stimulation is applied to the inserted needles) 4) some degree of clinical
effectiveness of the experimental therapy.
Results: A large number of trials of acupuncture on various musculoskeletal
disorders were found to fit the inclusion criteria. Eight well-designed
trials representing 571 patients were selected for review to highlight
the competency and versatility of acupuncture in effectively treating
a variety of musculoskeletal disorders. Three studies evaluate the effectiveness
of acupuncture on chronic neck pain, one on back pain, two on osteoarthritis
of the knee, one on rotator cuff tendinitis and one on fibromyalgia.
Conclusion: The evidence shows that acupuncture is a relatively
safe, cost-saving and effective therapy or adjunct in the treatment of
common chronic musculoskeletal conditions. However, more long-term studies
with larger patient groups and proper controls are needed.
Background: Acupuncture has been used in China for thousands of
years and continues to be used alongside Western medicine in the best
hospitals in China for the treatment of a vast range of medical disorders.
It has been and continues to be well-researched and documented in China,
however, many of the methods and principles upon which evidence-based
medicine is founded in the West, is ignored or not considered essential
in Chinese research. A number of Western clinical trials of acupuncture
have been performed in recent years that support the effectiveness of
acupuncture in the treatment of musculoskeletal conditions.1-26 Nonetheless,
acupuncture has not gained wide-spread acceptance by the medical community
as an effective therapeutic option due to the fact that the results of
these trials appear inconsistent, and many of these clinical trials are
plagued by the lack of a proper control, non-randomization, small numbers
of participants yielding low power or poor design. Many of these deficiencies
are due to numerous difficulties involved in conducting blinded randomized
placebo-controlled trials of acupuncture. Conducting trials on the specific
effects of acupuncture is significantly different than that of Western
pharmaceuticals, for example, in which blinding is relatively simple and
a placebo is relatively easy to create. Nonetheless, there are a number
of well-designed trials which strongly suggest that acupuncture is an
effective
treatment option for a variety of musculoskeletal disorders. The purpose
of this paper is to review and offer analysis for a small number of these
studies.
1) Chronic neck pain: Irnich, et al, compares the efficacy of acupuncture and conventional massage for the treatment of chronic neck pain.1
Methods: A randomized placebo-controlled trial method was used
with an active therapy control which received massage and a sham laser
acupuncture group to serve as a placebo control. This study took place
at three outpatient departments in Germany with 177 participants aged
18-85 years with chronic neck pain preselected by doctors at the outpatient
departments. The inclusion criteria were that patients had had a painful
restriction of cervical spine mobility for longer than one month and they
had not received treatment within the two weeks prior to the study. Patients
were randomly allocated to one of the three groups of acupuncture (56),
massage (60), sham laser acupuncture (61) and received five treatments
each over three weeks.
Treatment protocols: Patients were treated five times over three
weeks with each treatment lasting 30 minutes. Acupuncture and sham acupuncture
were performed by four experienced, licensed medical acupuncturists. Acupuncture
was performed according to the rules of traditional Chinese medicine,
including diagnostic palpation. Remote and local acupuncture points were
selected on the affected meridians and relevant ear acupuncture points
were included. Massage was performed by five experienced physiotherapists
and patients were treated with conventional Western massage. Sham laser
acupuncture was performed with a laser pen which was inactivated by the
manufacturer so only red light was emitted. Criteria for selection of
points were identical with those used in the acupuncture group. Every
point was treated for 2 minutes.
Outcome measures: Primary outcome measure was maximum pain related
to motion (Visual Analog Scale)(VAS) one week after treatment. Secondary
outcome measures were: range of motion (3D ultrasound real time motion
analyzer), pain related to movement in six directions (VAS), pressure
pain threshold (pressure algometer), changes of spontaneous pain, motion-related
pain, global complaints (seven point scale), and quality of life (SF-36).
Assessments were performed before, during and one week and three months
after treatment. Patients' beliefs in treatment were also assessed.
Results: One week after five treatments the acupuncture group showed
a significantly greater improvement in motion-related pain compared with
massage (difference 24.22 (95% confidence interval 16.5 to 31.9), P=0.0052
but not compared with sham laser (17.28 (10.0 to 24.6), P=0.327). Differences
between acupuncture and massage or sham laser were greater in the subgroup
who had had pain longer that five years (n=75) and in patients with myofascial
pain syndrome (n=129). Pain related to motion improved by more than 50%
compared with baseline in 29/51 (57%) patients who received acupuncture
compared with 18/57 (32%) who received sham laser and 14/57 (25%) who
received massage (c2 test P=0.008). The acupuncture group had the best
results in most secondary outcome measures, including significant differences
compared with massage in pain related to motion and direction immediately
and one week after treatment. Significantly more patients in the acupuncture
group considered their pain and global complaints improved three months
after treatment compared with patients in the massage group. There were
no differences in patients' beliefs in treatment.
Analysis: The results of this study are impressive in several respects.
First, the large number of participants included in the study afforded
the study a power of 80% with a 5% significance level, which the researchers
had sought. (Originally, their intention was to recruit 200 patients,
however, due to a low level of dropout rate, they obtained their power
objectives after recruiting 177 patients.) Second, acupuncture was most
effective in people who had had pain over five years and in those with
myofascial pain syndrome. Between 55% and 90% of patients with chronic
neck pain have the myofascial pain syndrome.27-28 Third, the study blinded
patients for placebo control. The sham laser acupuncture was a good choice
of control for the design of this study, although the researchers were
surprised by the results of the sham laser acupuncture as compared to
the massage. They were unable to explain this other than by enhanced placebo
effect. The sham laser acupuncture can be considered inert and controls
for the concept of having acupuncture in the mind of a participant who
recognizes it as a valid form of treatment. However, for those participants
who doubt the validity of such therapy, this may not equate to controlling
for the concept of needle insertion. Fourth, the number of objective and
subjective primary and secondary outcome measures coupled with the five
assessments made following the first treatment, the last treatment and
the three-month follow-up, adds strength to the study. Fifth, the acupuncture
point prescription used was adjusted to the patient's presentation and
condition based on traditional Chinese diagnostic concepts, instead of
giving all the experimental participants identical treatments. This is
significant because this is much closer to the way acupuncture treatment
is actually given by licensed acupuncturists in clinical situations, although
very few trials allow for this variance in treatment protocol. Also, acupuncture
treatments were done by more than one licensed acupuncturist, data was
analyzed at an independent institution, and documentation was made of
dropouts and adverse effects (included in study).
2) Chronic neck pain: Birch et al examine the specific and non-specific effects of Japanese acupuncture for chronic myofascial neck pain.
Methods: A
randomized single-blind clinical trial design was used. Forty-six patients
between the ages of 18 and 65 were randomly assigned to three groups:
relevant acupuncture, irrelevant acupuncture or an active treatment control
consisting of non-steroidal anti-inflammatory medication (Trilisate).
Patients were recruited through referrals to a hospital-based pain management
center and a neurology clinic and through public announcements. Inclusion
criteria included chronic myofascial neck pain lasting more than six months,
an identifiable painful area with heightened sensitivity to touch, and
unsuccessful response to physical therapy and medication.
Treatment protocol: The acupuncture treatment groups received 30
minutes of Japanese style acupuncture (shallow needling) rather than modern
Chinese manipulations to produce de qi. Each patient received a total
of 14 treatments (twice a week for 4 weeks, then once a week for 4 weeks,
then every other week for 2 weeks). A license acupuncturist with 13 years
clinical experience administered the acupuncture treatments. Chinese classically-defined
local and distal points were selected for the acupuncture group. The irrelevant
acupuncture group received similar needling techniques using Chinese acupuncture
locations as well, however the points selected were not cited in the treatment
of neck pain by the sources used. In both groups, the needles were connected
by IP (ion-pumping) cords, however in the irrelevant acupuncture group,
the cords were undetectably severed. An infra red light was applied over
the area in the relevant treatment group while the irrelevant group received
a light placed at a sufficient distance that no heat was felt.
Outcome measures: Each participant was asked to complete a series
of self-report measures at the start of the study. Psychometric measures
were also administered throughout the study and at completion of treatment.
The questionairres included: Comprehensive Pain Evaluation Questionnaire
(CPEQ), McGill Pain Questionnaire -- Short Form (SF-MPQ), Pain intensity
ratings, Short-Form Health Survey (SF-36), Symptom Checklist 90 (SCL-90-R),
Medication Diary, Belief in Helpfulness Measures, and Physiologic measures
(blood pressure, heart rate). The factors examined as predictors of outcome
pain ratings were experience with, beliefs about, and knowledge of acupuncture
before treatment; perceived efficacy, credibility, and logic of acupuncture;
perceived competence of the acupuncturist; and painfulness of acupuncture.
Outcome measures were administered before the start of treatment, at months
1 and 2 during treatment, at the end of treatment, and at three months
after treatment.
Results: Out of the 46 patients that began treatment, only 36 patients
completed the posttreatment and follow-up measures. Significant differences
were found between groups in terms of pre- and posttreatment changes in
average pain intensity. Patients assigned to relevant acupuncture had
significantly lower average hourly pain ratings after treatment (mean=1.87,
SD=1.90) than did those in the other two groups [non-relevant acupuncture:
mean=3.37, SD=2.14: control: mean=4.76, SD=2.05; F(27)=4.73; p<0.05].
Pre-and post-treatment changes in hourly pain intensity were also found
to be significantly different among groups [relevant acupuncture: mean=1.82,
SD=2.13; non-relevant acupuncture: mean=0.75, SD=1.34; control: mean=-0.64,
SD=1.96; F(27)=4.25; p<0.05]. Patients assigned to the no-acupuncture
control group used more Trilisate for their pain than did those assigned
to the acupuncture groups (p<0.05). No differences were found between
groups in terms of demographic characteristics, pre- and posttreatment
SCL-90 and SF-36 scores, and physiologic measures. Psychometric analysis
of perceived knowledge of acupuncture, perceived efficacy of acupuncture,
willingness to try any treatment for pain, and previous acupuncture experience
showed significant correlations only with previous acupuncture experience(r=0.55,
p<0.05) and confidence in acupuncture to alleviate pain in the future(r=.054,
p<0.05). Previous acupuncture treatment predicted the most change in
verbal ratings of pain on the total SF-MPQ[R =0.30; F(1,13)=5.60; p<0.05].
Analysis: The results of this study suggest that Japanese-style acupuncture
combined with IP cords and heat lamp is more effective in treating myofascial
neck pain than irrelevant acupuncture or medication alone. The strong
point of the study is the wide range of subjective and objective outcome
measures assessed including the psychometric analysis of patient expectations
and prior experience with acupuncture. In general, the non-specific effects
of previous acupuncture experience and confidence in acupuncture to alleviate
pain in the future correlated positively with treatment outcome. However,
it is unclear whether confidence that acupuncture can alleviate pain was
influenced more by the efficacy of treatment or by prior beliefs about
acupuncture. The fact that some flexibility was given to the acupuncturist
in local selection of acupuncture points in the treatment group is a positive
aspect of the study, reflecting a closer resemblance to the way it is
clinically practiced. All treatment was done by a single experienced acupuncturist
which allows for consistency and accuracy of point selection and needling
technique. However, the Japanese needling technique employed is not widely
utilized by acupuncturists in the U.S. who generally practice more traditional
Chinese techniques. Another attribute to the study is the long-term (three
month) follow-up assessment following completion of treatment. There are
two main drawbacks to the study. The first is the limited number of participants
in each group. There were notable clinical differences in report of pain
among groups and high correlations between some non-specific factors and
pain ratings, however significance was not attained. Second, the inclusion
of many different treatment components (acupuncture, IP cords and heat
lamps) makes it difficult to determine which were the most effective.
3) Chronic neck pain: David, et al compares the effectiveness of acupuncture with physiotherapy for chronic neck pain.3
Methods: A
randomized controlled trial method was used with an active control group
receiving physiotherapy. 70 adult participants aged 18-75 years, with
non-inflammatory neck pain were randomly assigned to either of the two
treatments with 35 patients in each group. Patients who were referred
over a one-year period by general practitioners, orthopedic surgeons and
rheumatologists with neck pain of longer than six weeks duration were
suitable for the study. Patients who had previous acupuncture or physiotherapy
for neck pain were excluded.
Treatment protocols: Each patient in both groups had six treatments
at weekly intervals. The physiotherapy was performed by a senior physiotherapist
(AAA) using standard localized mobilization techniques. The acupuncture
was performed by general practitioners registered with the British Medical
Acupuncture Society. The patients had local needling of trigger points
and, in addition, local needling and distal needling was employed. No
side effects from the acupuncture treatment occurred.
Outcome measures: Visual Analog Scale (VAS) of pain, the Northwick
Park neck pain questionnaire (NPQ) [6], a composite functional assessment
of joint range (neck range of motion) using a Myrin goniometer, and a
General Health Questionnaire (GHQ 28) were used. Three assessments were
done for each group one week prior to treatment, after the sixth treatment
and at the 6 month follow-up. Each assessment was performed without knowing
the results of the previous assessment.
Results: Both treatment groups improved in all criteria. Mean VAS
scores at baseline for both groups was over 50% and fell to approximately
30% for acupuncture and 20% for physiotherapy after six weeks. At six
months, the mean for the acupuncture group rose slightly to 35% and the
physiotherapy group rose to 27% with approximately 95% confidence intervals.
The choice of treatment was not significant (p=0.18). After six months,
22/29 (76%) of the acupuncture patients remaining still had lower scores
than at baseline, while 15/22 (68%) of the physiotherapy patients did.
On the neck pain questionnaire, the mean for both treatment groups falls
at the 6 week assessment and then remains fairly constant until the 6
month assessment. After 6 weeks, 24/29 (83%) patients improved with acupuncture
while all 27/27 (100%) physiotherapy patients improve. After 6 months,
23/29 (79%) of the acupuncture patients remain improved, while 19/23 (83%)
of the physiotherapy patients remain better, however, treatment was not
significant (p=0.72). Both the acupuncture and physiotherapy patients
improved their total GHQ (General Health Questionnaire) scores. The study
concludes that both acupuncture and physiotherapy are effective forms
of treatment while acupuncture was slightly more effective in patients
who had higher baseline pain scores.
Analysis: This study directly compares the effectiveness of acupuncture
and physiotherapy for the treatment of chronic neck pain. There is no
placebo control or non-treatment control. Although, there is no significance
in treatment outcomes of the two groups, the clinical significance of
both therapies are established by considerable difference between pre-treatment
and post-treatment outcomes of all subjective and objective measurement
criteria and the high percentages of patients showing improvement. This
study's strengths are that the patients were referred for the study by
general practitioners, surgeons and rheumatologists, six-month follow-up
and assessment is done and statistical analysis of the data is presented.
The acupuncture was done by general practitioners registered with the
British Medical Acupuncture Society and most likely are not fully trained
in the theory, diagnostic methods and point prescriptions of traditional
Chinese medicine. Hence the limited use of acupuncture to only local needling
of trigger points in conjunction with two classically defined acupuncture
points. This point selection method was used for all subjects in the acupuncture
group. Had the acupuncture been done by practitioners thoroughly trained
in traditional Chinese medicine, who were able to modify the acupuncture
treatment to suit each participant's particular condition, better results
may have been obtained.
4) Osteoarthritis of the knee: Berman BM et al. investigate the efficacy of acupuncture as an adjunctive therapy to standard care for the relief of pain and dysfunction in elderly patients with osteoarthritis of the knee.
Methods: A randomized controlled trial method was used, with evaluators
blinded to the groups at all assessments. Seventy-three patients between
the ages of 49-86 years with OA of the knee were randomly assigned to
either an acupuncture treatment group or a standard therapy control. (Based
on the pilot data, it was estimated that 35 patients would be needed in
both the treatment and control groups to give 80% power to demonstrate
a statistically significant improvement in total WOMAC score in both the
treated and control patients at eight weeks after enrollment.) Patients
were recruited from the Faculty Practice of the Division of Rheumatology
at the University of Maryland, and through public service advertisements
in radio and print media. Inclusion criteria consisted of: diagnosis of
OA of knee (ACR criteria applied) of at least six months duration, at
least moderate pain of knee for most days the preceding month, aged 50
years or older, taking analgesic or anti-inflammatory agents the month
prior to treatment, and documented radiographic changes of OA.
Treatment protocol: The participants originally assigned to the acupuncture
treatment group and those who crossed over from the control group received
acupuncture biweekly for 8 weeks. Patients were asked to remain on their
baseline analgesic/anti-inflammatory regiments as well and not to begin
any new physiotherapy or exercise programs. Selection of acupuncture points
was based on TCM theory for Bi syndromes, which uses local and distal
points on channels that traverse the area of pain. A specific set of points
were used for all patients. De qi sensation was verified by the patients.
Also, electrical stimulation for 20 minutes was given by attaching electrodes
to the needles at two local points, Dubi (St. 35) and extra Xiyan.
Outcome measures: The patients were examined by a rheumatologist
at baseline, during which a general physical exam was performed, a standing
bilateral knee radiograph of the tibiofemoral joints was taken and scored
using the Kellgren-Lawrence scale, and a detailed rheumatological exam
was given. Patients were then asked to record their responses to the WOMAC
and Lequesne scales. The WOMAC is a validated, multidimensional self-report
scale used to assess pain, stiffness and physical function for OA of the
knee.29 The Lequesne scale is designed to measure patient status at different
stages of OA and has particular value in assessing OA in weight-bearing
joints. The rheumatologist was blinded to the participant group assignment
at the time that baseline assessments were made. Bellamy et al.30 have
found that changes in rheumatological exam scores are poor outcome measures,
and therefore they were not monitored throughout the trial. Patient scores
were ascertained at weeks 0,4,8 and 12 during the trial. In addition,
crossover was done by giving acupuncture treatment to patients in the
control group upon completion of the 12 weeks and data is analyzed for
the within-group analyses.
Results: Analyses were performed on the 73 participants who were
randomized for the intention-to-treat (ITT) analysis using a 'last score
carried forward' technique. This is a conservative means of applying ITT
methodology, in which the last value recorded before dropping out is carried
forward to each missing time period, assuming no change in outcome. A
separate analysis was also performed on the 58 completers. Longitudinal
linear regression analyses and residual analyses were done. Participants
with missing values were dropped from analysis. Sample sizes for the within-group
analysis were 60 for 4 weeks, 58 for 8 weeks and 52 for 12 weeks. There
were highly significant overall differences in patterns of change over
time on all outcome scores, based on the group by time interactions (P<0.001)
as well as each time period using t-tests (P<0.001). Using separate
repeated measures analyses to assess time trends within each group, the
scores showed significantly different trends in the two groups, with decreases
in the acupuncture group over time which were not seen in the comparison
group. In the acupuncture group, the total WOMAC scores decreased by 34%
at week 4, and 42% at week 8. There was a slight increase in totals at
week 12 (4 weeks after completion of treatment). The decrease in WOMAC
scores in the acupuncture group had similar patterns for both the pain
and disability subscales. The Lequesne scale also showed significant decreases
in severity in the acupuncture group but not in the control. There was
a 14% decrease at 4 weeks, 25% at 8 weeks, and a maintenance of improvement
of 20 % at 12 weeks. In within-group analyses, a repeated measures analysis
found significant changes in WOMAC total scores over time (P<0.001).
The time effect was seen at 4 weeks (P<0.001), 8 weeks (P<0.001),
and 12 weeks (P<0.001). There were no significant differences between
the original acupuncture group and the crossover group at any time periods.
On all three points of measurement and for all outcome measures, there
were significant differences reported from initial baseline scores. No
patients reported side-effects.
Analysis: This is a strong study supporting the use of acupuncture
in OA of the knee. The findings were consistent when all enrollees were
analyzed in an ITT analysis with last score carried forward, or when only
completers were analyzed. A sufficient number of participants were recruited
to give a power of 80% to the study. It is also significant that no side-effects
were reported, since many of the standard care medications produce GI
problems that are quite serious, particularly in the elderly.31-35 The
statistical significance between the acupuncture and control groups 4
weeks after completion of treatment is noteworthy, although no long-term
follow-up was done. The absence of an objective measurement, such as a
50 ft. walk time or joint range of motion, may be an issue. However, according
to recommendations from OMERACT III and the Osteoarthritis Resarch Society
task force36 objective physiological measures are not considered part
of the core assessments required for appropriate OA clinical trial data.
Two limitations to the study is the lack of a placebo control group to
examine non-specific effects of acupuncture and the lack of a group receiving
more frequent acupuncture treatment than every other week. However, there
is a Phase III study planned of acupuncture treatment for knee OA which
would be a large multi-center RCT with three arms: real acupuncture, sham
acupuncture and control. Questions regarding the recommended number of
treatments, the value of maintenance dosing and measurement of differences
between the effects of true acupuncture and the possible non-specific
effects of the treatment experience would be investigated.4
5) Osteoarthritis of knee: Christensen BV, et al. conduct a long-term study on the effects of acupuncture on severe osteoarthrosis of the knee. 5
Methods: A
randomized controlled single-blind clinical trial method was adopted.
Twenty-nine patients with a total of forty-two osteoarthritic knees were
randomized into two groups. One group received treatment and the other
served as a no-treatment control group. Investigators were not aware which
group the participants belonged to during this period, making this a single-blinded
study. After nine weeks, the non-treatment group received treatment as
well in a crossover design. At the end of the first study period (week
16), a questionnaire referring to the effects of the treatment was completed.
Those with subjective benefit were offered participation in the long-term
study, which continued for 40 weeks and 49 weeks from the beginning of
treatment for each group. All patients up to 75 years of age on a waiting
list for knee arthroplasty due to osteoarthrosis, were invited to participate.
Exclusion criteria were: other connective tissue diseases affecting the
knee, neurological diseases, psychiatric disorders, acupuncture treatment
within one year, or knee-joint steroid injections within the start of
study. All knees were X-rayed before treatment and classified according
to Ahlback's arthrosis classification I-V. All through the study the authors
used median values and 95% confidence limits of median difference, except
for the yes/no questionnaire at week 16 where binomial confidence limits
(BC limits) with the very high level of 99% confidence were used. A 5%
level of significance was adopted.
Treatment Protocol: The acupuncture treatment was standardized
throughout the study. Five specific local and one distal Chinese acupuncture
points were inserted to a pre-determined depth. De qi needling sensation
was sought at all points. The needles were manually stimulated during
20 minutes of treatment. For patients with osteoarthritis of both knees,
both knees were treated. Group A was treated twice a week during weeks
1-3 while Group B served as a no-treatment control during weeks 1-9. Group
B was then treated twice a week during weeks 9-11. Those who participated
in the long-term study received 3 or 4 treatments during weeks 23-24,
followed by one treatment every month (if needed) until week 49.
Outcome Measures: Seven objective evaluations (OE) were done during
the 49 weeks by investigators who were not aware which group the patients
belonged to. The last two OE were done after 3 and 6 months in the long-term
study. The OE were: time taken to walk 50 m, time taken to climb 20 steps
on a staircase and the HSS knee function scale. The HSS is an extensive,
internationally acknowledged assessment instrument developed by the Hospital
for Special Surgery in New York for follow-up evaluations of knee arthroplasty.
It takes into account seven objective measures, such as range of knee
motion, walking distance and muscle strength, and one subjective measure:
pain at rest and at exercise. During the total study period of 50 weeks,
the patients made 18 pain evaluations (PE) with registration of analgesic
intake and a self-assessment of pain intensity on a VAS. Pain evaluations
were done 9 times during the short-term study and 9 times during the long-term
study.
Results: 32 patients had 42 knees treated. 80% of all the subjects
had experienced pain relief (BC limits 61-92%) at week 16, with an equally
good effect on pain at night, pain while resting and pain caused by strain.
The median time for symptoms was 4.3 years (range 6 months to 44 years).
Among those in the low bracket (<4.3 years), 96% experienced a benefit
on pain versus only 63% in the high bracket (P=0.01, F-test). Significant
differences were found between the two groups at the second and third
OE (weeks 4 and 8) in all three objective measures: the HSS score and
time for walking and climbing stairs. In the third OE, group A had a median
HSS score=74.8 (range 49.94, 95% confidence limit 61-82, P<0.01). In
group B, the median HSS score=59.1 (range 43-81, 95 % confidence limit
55-67). In walking 50 m, group A had a median time=46.4 sec. (range 36-84,
95% CI 44-58, P<0.01); group B had a median time=67 sec. (range 40-117,
95% CI 63-73). In climbing 20 steps, group A had a median time=19.0 sec.
(range 10-49, 95% CI 14-25, P<0.01); In group B, the median time=35.5
sec. (range 12-64, 95% CI 26-50). The median value for knee ROM before
treatment was 110° in both groups. After treatment of group A, at
the second OE, the median value was 119.6° versus 110° in group
B (P=0.5, MW test). After treatment of all 42 knees at the fourth OE,
there was a significant improvement of the total sample from 110°
to 122.5° (P=0.02, W-test). The median VAS score decreased significantly
in group A after treatment: PE-1=6.0 (range 2.9-9.8, 95% CI 5.2-7.3) and
PE-2=1.9 (range 0-7.4, 95% CI 1.1-3.1). PE-1 versus PE-2 (P<0.0001,
W-test). A significant result was obtained in group B after treatment
also: PE-5=7.4 (range 0.5-9.4, 95%CI 3.7-8.9) and PE-6=3.3 (range 0-9.1,
95% CI 1.2-5.8). PE-5 versus PE-6 (P=0.02, W-test). In group A the beneficial
effect of acupuncture decreased with follow-up time, but was still significant
at week 12. In group A there was a significant reduction at PE-2 in consumption
of non-steroidal anti-inflammatory drugs (NSAID) after treatment, but
not in peripheral analgesics, although a smaller number of tablets was
needed. In the total sample the reduction for both drugs was significant
at PE-6 compared to pre-treatment values. 22 patients had experienced
subjective benefit during the short-term study. Five had been called in
for surgery, so only 17 continued in the long-term study. On average 0.91
treatments wee given per month per knee. There was a significant decrease
in pain (P=0.01 or less, W-test) through the combined period of the two
studies, as measured by VAS. OE-6 and OE-7 also showed highly significant
effects compared to OE-1 through the total study period (P<0.0001 and
P<0.005, respectively). There were highly significant reductions in
both NSAID and peripheral drug consumption through the 50 weeks compared
to pre-treatment values (P=0.001 to P=0.004). At week 49 those remaining
were asked if they were still interested in surgery. Of the 32 patients
in the original project, seven were no longer interested in surgery if
their present condition lasted.
Analysis: This study has many strengths. First, it clearly specifies
the chosen acupuncture points, number of sessions, mode of stimulation,
duration and frequency of stimulation and whether de qi was attained.
Second, both short-term and long-term (50 week) assessments were made
frequently during the course of treatment and subjective and objective
outcome measures were performed. Significant differences between treatment
groups were found in all three objective outcomes between OE-2 and OE-3.
Significant differences were found in VAS pain scores after treatment
in group A, then in group B, after crossover treatment was given and there
was a significant reduction in pain in patients with this condition less
than 4.3 years compared to those with the condition greater than 4.3 years.
Significant differences were also found in group A and B in knee ROM upon
completion of treatment, compared to baseline. Assessment of patient intake
of medication was also performed. Significant reductions in NSAID intake
was found in the acupuncture group at the second pain evaluation and in
both groups there was a significant reduction in both NSAID and peripheral
analgesic intake after one year compared to baseline. Also of interest
is the fact that at the conclusion of the trial, of the thirty-two original
participants, seven were no longer interested in surgery if their present
condition lasted. The cost of knee surgery in Denmark, where the study
took place is US$9000, so substantial savings could be made if the effect
was sustained.
6) Chronic low back pain: Lehmann et al. investigate the efficacy of electroacupuncture and TENS in the rehabilitation of chronic low back pain.
Methods: A
randomized controlled single-blind (caregivers) clinical trial method
was used. 54 patients were randomly assigned to treatment with electroacupuncture
(n=17), TENS (low intensity transcutaneous electrical nerve stimulation,
n=18) and TENS dead battery placebo (n=18). Patients with chronic disabling
low back pain were screened at the University of Iowa Orthopedic Clinic.
Exclusion criteria included patients who were considered candidates for
lumbar surgery, low back pain for less that three months, and patients
with spinal deformities such as osteomyelitis of spine, discitis, tumor,
ankylosing spondylitis, vertebral fractures and structural scoliosis.
One patient refused to accept assignment, leaving 53 patients in the study.
Treatment Protocol: For the TENS and TENS dead battery groups,
the patients had the electrodes attached and were stimulated with a live
battery. For both groups, the intensity of stimulation was reduced to
the point that the patient could not feel the stimulation. At that point,
the assigned battery (active or dead) was placed in the unit and the unit
was placed in a plastic case. The physician and physical therapist applying
the TENS were blind to the type of battery being used. Only the nurse
investigator knew which patient was receiving active or dead battery treatment.
TENS and TENS dead battery treatments were offered daily except weekends
during the three week program. Points of stimulation were over the area
of pain. Electroacupuncture was given twice weekly for the three weeks.
A certified acupuncturist experienced in its application stimulated the
patients with needles. The stimulus was a biphasic wave and was increased
to the patient’s level of tolerance. Stimulation was on the inner
and outer bladder meridian if the pain was lateral (sciatica). Additional
points were usually stimulated according to the patient’s pattern
of pain. All patients also took part in a comprehensive multidisciplinary
educational program and twice daily exercise training sessions.
Outcome Measures: At admission, patients completed an objective clinical
history questionnaire and a detailed physical exam was recorded. Physical
measurements of trunk strength and spine range of motion were recorded.
A patient’s periodic record, physician’s periodic record, and
trunk strength and ROM measurements were performed at admission, discharge
and a 6-month return visit. Trunk strength measurements were averaged
and recorded in kilograms. On the patient’s periodic record, the
patient rated (1) the degree of peak pain experienced since the last assessment
and (2) the general level of pain experienced on an average day. These
assessments were recorded by VAS. Patients also estimated their degree
of disability and ability to perform 15 activities of daily living. On
the physician’s periodic record, the physician estimated the average
level of pain expected for the patient, the degree of impairment the patient
had, and patient medication usage. These items were summed to derive a
total Low Back Rating Scale Score. The greater the points mean better
function, less pain, and less disability. In addition to the rating scale
components, each patient indicated the degree of benefit received from
the overall program at the discharge and return visit. Patients were asked
to rate the contribution that each component of the program made to their
overall benefit.
Results: Patient medical records indicated a tentative diagnosis
of low back pain of unknown etiology (n=26), lumbar motion segment instability
(n=8), lumbar spinal stenosis (n=8), herniated nucleus pulposus with radiculopathy
(n=5), discogenic pain without radiculopathy (n=4) and functional low
back pain (n=2). Of the 17 patients in the acupuncture group, 4 dropped
out after only one treatment. In the TENS and TENS dead-battery groups,
4 of 18 and 3 of 18 dropped out after 3 treatments, respectively. A second
source of attrition was the failure of patients to return for the 6-month
follow–up visit. 5 of the acupuncture and 4 of the TENS patients
did not return. Although failure to return did not hinder the assessment
of treatment effects from admission to discharge, an overall picture of
treatment effectiveness over the extended time period was more difficult
to assess. Mean scores on all ten outcome measures demonstrated highly
significant gains from admission to discharge (P value ranged from 0.0117
to 0.0001), with the exception of medications and peak pain scores (P
value ranged from 0.045 to 0.0001). In general, the mean scores for each
group demonstrated improvement from admission to discharge, but regression
from discharge to return. This typical pattern was demonstrated for the
Total Rating Scale Score where the treatment main effect and treatment
by time interactions were not statistically significant but the time main
effect was significant (P=0.0001). Overall, the TENS, TENS dead-battery
and acupuncture groups showed long-term benefits as measured from admission
to return (P=0.01, P=0.001, P=0.004, respectively). On the average pain
measure, there was a statistically significant treatment by time interaction
(P<0.03). The acupuncture group significantly improved from admission
to discharge (P=0.005) and showed a non-significant gain from discharge
to return. Whereas the TENS and TENS dead-battery groups did not demonstrate
significant long-term gains as measured from admission to return (P=0.50
and P=0.23, respectively), the acupuncture group did (P=0.0008). At the
return visit the acupuncture mean average pain score indicated significantly
less pain compared to the dead-battery and active TENS groups (dead-battery=7.94,
TENS=8.28, acupuncture=11.08, P=0.04). At discharge, the acupuncture mean
scores ranked highest on 10 of the 11 measures and middle on 1 of 11 (P<0.0001).
At return, the acupuncture mean scores ranked highest on 6 of the 11 measures
and middle on 5 of the 11 (P<0.05). Patient assessment of the contribution
to overall benefit made by the education, exercise and electrotherapy
components of the rehabilitation program demonstrated that, for each of
the 3 treatment groups, education was considerd to have contributed more
to the overall benefit than the electrotherapy (P<0.05).
Analysis: Due to many factors, the results of this study are difficult
to interpret. Although there were no significant differences in improvement
between the treatment groups, the electroacupuncture group consistently
ranked the highest across all outcome measures, suggesting that this form
of electrical stimulation was efficacious. The patients perceived that
the educational component contributed the most to their overall benefit
and found the electrical stimulation least important. These results do
not imply that there was no benefit to the patients from their electrical
stimulation. Rather, they imply that the patients received significant
overall benefit from the total program and that the electrical stimulation
was not detected to add significantly to that benefit. These results could
well be due to the low power of the study due to small sample size and
high rates of patient dropout and non-return of patients for the 6-month
assessment. These factors increase the risks of the study making a type
II error. It is interesting that the dead-battery placebo group scored
surprisingly high in some of the outcome measures which led to a failure
to find statistical differences between this group and the active TENS
and acupuncture groups. Some possible factors which may have been related
to the less than optimal results for the acupuncture group compared to
the TENS groups are the methods which were used in the treatment of the
electroacupuncture group. First, the attainment of de qi was not verified
before electrical stimulation and this appears to be an important part
of an effective treatment. Second, needle placement and needle technique
for the electroacupuncture group is not adequately described which leads
one to wonder about the consistency of the treatments. Specific acupuncture
points used are not mentioned in the study. When points are described,
they do not appear to be appropriate. (For example, in the case of lateral
pain due to sciatica, the inner and outer Bladder points were used, but
not the Gall Bladder points.) Third, the frequency of treatment for the
groups was not consistent. The TENS group received treatment daily except
weekends for three weeks (15 treatments), while the acupuncture group
receive treatment only twice a week (6 treatments). Not only is the number
of treatments considerably less for the acupuncture group, but a standard
treatment for chronic low back pain should offer at least 8-12 treatments
before assessment of efficacy can be made. Lastly, in order to determine
a level of stimulation in the TENS group which was not perceivable by
the participants, the caretakers gave the patients stimulation by active
TENS and dropped it down to an imperceptible level (going by word of the
patient). This has numerous problems with it, one being that the patients
actually do receive some stimulation at the start of each dead-battery
placebo treatment. Also, the caretakers are forced to rely on the word
of the patient as to when the level of stimulation is decreased to a level
that is no longer perceptible.
7) Rotator cuff tendinitis: Kleinhenz, et al. compare the effects of acupuncture and a newly-designed placebo needle in rotator cuff tendinitis.7
Methods: A
randomized placebo-controlled single-blind (patients and evaluators) clinical
trial was designed to ascertain whether acupuncture needling vs. placebo-needling
without penetration of the skin using identical therapeutic settings for
both groups is more effective. Athletes suffering from shoulder pain were
recruited through articles in the local newspapers, by informing all sports
clusbs, all orthopedic and physiotherapy practices, posters at sport facilities
and university bulletin boards in the Heidelberg, Germany region. Patient
histories were taken and diagnoses of rotator cuff disease were made by
two experienced orthopedic specialists according to accepted standards.
Ultrasound examination of the rotator cuff were performed to exclude tendon
rupture, as well as X-rays to exclude foci of calcifications and degenerative
changes within the joints. Other inclusion criteria included: duration
of disease more than 4 weeks and no acupuncture therapy during the last
6 months. 52 patients met the inclusion criteria and were randomized into
two groups: group A which received acupuncture needling (n=25) and group
B which receive placebo needling (n=27). Based on a pilot study done prior
to this trial, analysis was done and showed to detect a difference in
the change from baseline of 10 points between groups, 23 patients were
needed in each treatment group to give a power of 80%. The level of significance
was defined as a=0.05. 95% confidence intervals are reported and data
was analyzed on an intention-to-treat basis including all randomized patients.
For patients that did not show up for the final evaluation, initial assessment
data was used.
Treatment Protocol: Patients received eight acupuncture sessions
in 4 weeks. The acupuncturists were aware of the different treatments,
but tried not to give any information to the patients. Patients were treated
in the same room to keep the setting identical. Questions about acupuncture
were answered using an identical ‘answer catalogue’. Painful
points were chose as well as other according to the symptoms. A combination
of up to 12 points was used out of a list of 20 local and distal points
(table provided in study) which have been described as being effective.
The same combination was used for four sessions. If no improvement was
reported another exam was performed to choose alternate points for the
next four sessions. For this study, a special ‘placebo needle’
was designed. The needle body is not fixed inside the copper handle, like
most needles, but moves into the handle when its blunt end is pressed
against the skin, and so the needle is shortened. A small pricking sensation
is felt by the patient, simulating the puncture of the skin. This gives
the impression to patients by sight and sensation that the needle is being
inserted into the skin. To fix the needle, a plastic ring covered by a
plaster was used. The same procedure was also used in the real acupuncture
group to assure exactly the same therapeutic setting in both groups. However,
in the acupuncture group, the needle was inserted into deeper tissue layers.
No procedure differences can be realized by the patient or by third persons.
This needle was tested in 60 volunteers and proved to be sufficiently
credible to be used in this trial as a control.38
Outcome measures: The primary outcome variable was the change from
baseline in the modified Constant-Murley score. This score is based on
various subjective and objective measures including pain, activities of
daily living (training, sleep, positioning, etc.), painless range of motion
and strength. A range of points is assigned to a variety of possible outcome
measures so that a total of 100 points is possible in complete pain-free
ability and activity of shoulder, ROM and strength. Assessments of shoulder
function were made prior to the start of treatment by an orthopedic specialist
using the modified Constant-Murley score, then again at least two days
after the last treatment was completed. The orthopedist of these assessments
was not informed about the treatment group of the patients. Three months
after the end-point assessment, letters were sent to the patients to gain
some impression about long-term effects. The questionnaires contained
the first subjective items (35 points) of the modified Constant-Murley
score. Patients were also asked about treatment necessity after the trial
and overall judgement of acupuncture treatment.
Results: Baseline characteristics were subjected to statistical
analysis and revealed no relevant differences. Seven patients dropped
out and they did not show up for end-point assessment after treatment
(three patients in the acupuncture group and four in the control; reasons
for dropout are provided in the study). Two patients received additional
treatment with ice during the study and two patients received physiotherapy,
all four being in the control group. The others did not have any additional
treatment during the 4-week trial period. The mean change from baseline
of modified Constant-Murley scores were 19.2 points (SD 16.1, min=-13,
max=50) for the acupuncture group and 8.37 points (SD 14.56, min=-20,
max=41) for the control group (P=0.014; CI for difference between groups:
2.3; 19.4). Subjective patient evaluation after the last treatment as
expressed to the acupuncturists was positive in 17 patients (68%) of the
acupuncture group and 14 patients (52%) of the control group (P=0.27).
There was also no difference in the credibility of the treatment setting
in both groups after the first and last treatments. 18 patients from the
acupuncture group and 17 patients from the control group returned the
questionnaire (35=67%). After the trial seven patients of the acupuncture
group received further treatment, six with physiotherapy, one with medication.
Ten patients from the control group were treated further, nine with physiotherapy
and one with local injections. Subjective elements of the modified Constant-Murley
score were compared with the ratings after 4 weeks for these 35 patients.
In the acupuncture group there was no difference between the score values
for pain intensity after 4 weeks (10.00 C-M points, SD 4.54) and 4 months
(8.89, SD 4.04). The control group showed further improvement from 4 weeks
(6.47, SD 3.86) to 4 months (9.41, SD 4.64).
Analysis: This study shows a statistically significant difference
between acupuncture needling and placebo needling in rotator cuff disease
(P=0.014). This is especially impressive given the intention-to-treat
analysis and the high dropout rate. The most important aspect of this
study is its well-designed placebo needle used to control for acupuncture
treatments. With this needle, it is possible to create exactly the same
setting in acupuncture and placebo. It is possible a small acupressure
effect may be induced by this method since the needle does provide some
stimulation at the actual acupuncture location. For some Oriental acupuncturists
(ie: some Japanese acupuncturists), this may arguably induce some of the
same therapeutic effects as the actual penetration of the skin. However,
in classical traditional Chinese medicine, penetration of the skin is
an integral part of the therapeutic effect.39 Even if the placebo needling
does have some therapeutic value, this does not detract from the statistically
significant results of the study. Follow-up by questionnaire after 3 months
suggested that the control group improved to similar results as the acupuncture
group with further treatment after the trial. This may have been due to
the increased use of physiotherapy in the control group after conclusion
of the study or due to the fact that only 67% of the patients returned
their questionnaires. Regardless, the pain rating in the acupuncture group
did not worsen with time, suggesting a long-term effect.
8) Fibromyalgia: Deluze, et al. report the results of a controlled trial of electroacupuncture in treating fibromyalgia.8
Methods: A
randomized, controlled, single-blind, clinical trial method was adopted,
with patients and evaluating physicians blinded to the treatment groups.
Adult patients referred to the Division of Physical Medicine and Rehabilitation,
University Hospital in Geneva, Switzerland for fibromyalgia as defined
by the American College of Rheumatology were admitted to the study. Exclusion
criteria were severe concomitant disease, treatment with morphine-like
drugs or anticoagulants, peripheral neuropathy, bleeding disorders, and
past treatment with acupuncture. The patients continued with their other
usual treatments (physiotherapy, analgesics, anti-inflammatory agents,
tricyclic anti-depressants). Seventy patients were randomized to electroacupuncture
(n=36) or control (n=34). Based on data from a previous study, it was
calculated that 68 patients would be needed for this study for a=5% with
80% power.
Treatment protocol: Treatment consisted of six sessions of electroacupuncture
spread over three weeks. An electrostimulator with five pairs of electrodes
was used. The current was rectangular with a biphasic top out voltage
of 10 volts at 1000 ohm and frequency 1-99 Hz with continuous scanning
of the frequency spectrum. Intensity of the current was maximally 10mA,
which is above the perception threshold but just below the pain threshold
and induces a visible muscular contraction. Four to ten stainless steel
needles were implanted to a depth of 10-25mm and fixed with tape. Depth
of insertion was determined according to the sensitivity of the site (needling
sensation or “de qi”) as indicated by the patient. In the electroacupuncture
group, four common acupuncture points were used (LI 4, bilaterally and
St. 36, bilaterally). At most, six other locations were chosen depending
on the patient’s symptoms and pain pattern and according to the empirical
efficacy of the sites in the treatment of pain. In the control, a similar
number of needles were used but they were put about 20mm away from the
point which would have been chosen for real electroacupuncture. The needles
were inserted to a depth of 3-4mm and fixed with tape. The current used
was similar to but weaker than that used in the real procedure. No increase
was made after the threshold of perception had been reached. There was
no muscular contraction. Both electroacupuncture and sham electroacupuncture
were done by the same investigator. Patients were seen individually, at
different times, and had no opportunity to meet.
Outcome measures: Evaluation was done before the first session and
after the treatment and comprised eight measurements: pain threshold,
number of analgesic tablets used, regional pain score, pain recorded on
visual analog scale, sleep quality, morning stiffness, and patient’s
and evaluating physician’s appreciation of the patient’s general
state. Pain threshold was determined by a pressure gauge calibrated in
kg/cm2 , attached to a plunger with a 1 cm round rubber tip. Pain threshold
was measured over 18 tender points as defined by the American College
of Rheumatology and the area with the lowest value used for the evaluation.
Results: The two groups were not significantly different in any
aspect except for an excess of men in the control group (p=0.015). Fifteen
patients withdrew from the study and were not re-evaluated. In the electroacupuncture
group six patients withdrew and in the control group five patients withdrew
(reasons given in study). The 15 patients who withdrew did not differ
significantly at the beginning in any parameter from the whole population.
Patients in the electroacupuncture group improved significantly in all
parameters except morning stiffness whereas there was no change in the
controls. For pain threshold (kg/cm2) pre-treatment mean=1.36 (SE 0.21,
95% CI= 0.94-1.79) and post-treatment mean=2.32 (SE 0.32, 95% CI= 1.67-2.98)(p=0.0027).
For number of analgesic tablets used previous week, pre-treatment mean=10.36
(SE 2.97, CI= 4.25-16.47) and post-treatment mean=6.86 (SE 2.84, 95% CI=1.04-12.68)(p=0.0084).
For regional pain score (1-105) pre-treatment mean=43.43 (SE 3.28, 95%
CI=36.71-50.15) and post-treatment mean=26.46 (SE 3.82, 95% CI=18.63-34.30)(p=0.0000).
For pain on VAS (1-100), pre-treatment mean=56.61 (SE 3.19, 95% CI= 50.06-63.15)
and post-treatment mean= 39.89 (SE 4.97, 95% CI=29.70-50.06)(p=0.0020).
For sleep quality (1-10), pre-treatment mean=4.11 (SE=0.32, 95% CI=3.45-4.77)
and post-treatment mean= 5.96 (SE 0.47, 95% CI= 5.00-6.92)(p=0.0004).
For morning stiffness (min), pre-treatment mean=57.86 (SE 11.80, 95% CI=33.65-82.07)
and post-treatment mean= 40.89 (SE 10.64, 95% CI=19.06-62.73)(0.0627).
For patient’s appreciation (1-10), pre-treatment mean= 4.82 (SE 0.31,
95% CI=4.18-5.46) and post-treatment mean= 6.46 (SE 0.43, 95% CI= 5.58-7.35)(p=0.0018).
For evaluating physician’s appreciation (1-10), pre-treatment mean=5.21
(SE 0.32, 95% CI=4.56-5.87) and post-treatment mean= 7.00 (SE 0.41, 95%
CI= 6.17-7.83)(p=0.0001). Post-treatment values were significantly better
after electroacupuncture in five of the eight parameters studied when
compard with the control group: pain threshold (p=0.0303), number of analgesic
tablets during last week (p=0.0945), regional pain score (p=0.0570), pain
on VAS (p=0.0246), sleep quality (p=0.0782), morning stiffness (p=0.0321),
patient’s appreciation (0.0111), and evaluating physician’s
appreciation (p=0.0034). Pain threshold, which was considered to be the
main parameter in this study improved by 70% in the acupuncture group
and 4% in the control group. This difference was significant.
Analysis: The results of this study clearly support the use of
electroacupuncture in the treatment of fibromyalgia for all outcomes measured.
Much thought and care went into the design of this study, especially in
regards to the design of the control. First, care was given to ensure
that the experience of the acupuncture in the control group was almost
identical with that of the treatment group while at the same time, keeping
any possible therapeutic effect of the control group to a minimum. Sensations
were induced by needling the skin, but care was given to needle points
almost an inch away from the actual points and then only at shallow depths.
Also, a weaker electric current was used than in the actual treatment
group. This gave the impression to the control patients that they were
in fact receiving the electroacupuncture treatment. Second, the designers
of the study only allowed patients to participate who had no previous
experience with acupuncture and the patients were treated individually
and had no way to compare their treatments with others in the study. These
measures were taken to prevent any outside knowledge of the group to which
they were assigned. Based on similar drop out rates and rates of side
effects between the two groups, the authors of the study did believe the
patients were unaware which group they were in. The advantage of acupuncture
over antidepressants or anti-inflammatory drugs often used in fibromyalgia
is the low rate of side effects. Acupuncture and especially electroacupuncture
might become a useful adjunct in the treatment of fibromyalgia.
Conclusion: To date, the literature reveals a number of randomized
controlled trials which examine the therapeutic value of acupuncture in
treating chronic musculoskeletal disorders. There is substantial variance
in the methodological quality and validity of these trials in the literature.
Even among these controlled trials presented, there are many different
approaches to designing a control group, the blinding of participants
and evaluators and the treatment protocol and point prescriptions utilized
in the study. The purpose of this review was to present some of the many
randomized controlled trials of acupuncture showing a positive therapeutic
effect in common chronic musculoskeletal conditions. Each of the different
types of control methods used in these trials offers valuable information
on the specific and non-specific effects of acupuncture. Sham acupuncture:
Sham controls readily control for placebo effects because they closely
mimic true acupuncture. It can be argued that needling non-acupoint sites
implies methodological problems due to local effects on healing by electrical
effects of skin injury39, release of vasoactive substances40, trigger
point effects41, and activation of a pain suppresssing system in the spinal
cord (diffuse noxious inhibitory controls)42. However, regardless of these
possible therapeutic effects, in many of these studies using sham acupuncture
as a control, there remains a significant statistical difference between
acupuncture and control in outcome measures. If there is a therapeutic
effect from sham, there is still such efficacy from treatment to result
in statistically significant differences between the two groups. Placebo:
The use of a placebo is most commonly associated with the double-blind
trial design. The placebo provides a means of assessing the overall treatment
effect resulting from “expectations of benefit” by the participant.
It mimics the actual treatment so the patient believes they are receiving
the therapy. To be successful, it must be believable by the participant
yet offer no therapeutic value.43 In the case of a pharmaceutical, it
is relatively easy to create. In the case of acupuncture, however, it
is much more difficult because of the nature of the therapy. The patient
sees and senses the needles as they penetrate the skin. Also, in order
to attain de qi, which is considered to be a crucial part of acupuncture
by Chinese medical standards and whose therapeutic value has been supported
by Western trials36, it is necessary for the patient to experience a specific
sensation. In fact, de qi can only be confirmed by relying on the patient’s
subjective sensations.38 The recently-designed placebo needle used in
the rotator cuff tendinitis acupuncture trial was a milestone in the field
of acupuncture research. It satisfied the necessary conditions of a placebo.
The patient was unable to differentiate by sight the placebo from the
actual treatment and even received a sensation at the acupoint, resembling
the insertion of a needle. At the same time, it is assumed that very little
therapeutic value was offered to the patient due to non-penetration of
the skin. The only possible problem with this placebo method is that de
qi cannot be attained. The authors of this study foresaw this potential
problem and were able to minimize this by allowing only participants who
had never experienced acupuncture before. They therefore were less likely
to have knowledge about this condition. Double-blind studies: The main
reason why double-blind studies are rarely done in acupuncture trials
is because it is extremely difficult to blind the practitioner giving
the treatment. In order to do this, some type of placebo needle would
need to be devised which would allow the acupuncturist to give either
the placebo needle or actual treatment, yet prevent the acupuncturist
from knowing which is being given. For example, some type of needle machine
might be designed which allows the acupuncturist to hold the needle machine
over an acupoint and push a button, and the machine randomly chooses whether
or not to give the actual needle or placebo and records the choice made.
This would have to be unnoticeable to both the patient and the acupuncturist.
Nonetheless, the use of blinded treatment assessors strengthens the methodological
rigor of the single-blind trial. Study Design: The other methodological
question that needs to be addressed is whether it is more fruitful to
create studies based on Western medical diagnoses with a standardized
treatment protocol (ie: the same point locations used with the same needles
inserted with the same needling technique and depth for all participants),
or framed in the diagnostic criteria and treatment protocol of traditional
Chinese medicine. When diagnosis is framed primarily in biomedical terms
and the acupuncture needling protocol is standardized, as many of the
current trials being conducted are, the question driving these trials
becomes: Is acupuncture effective when delivered as a fixed course of
treatment based on biomedical diagnosis? In short, the question becomes:
Is acupuncture an effective biomedical treatment?44 It must be remembered
that when acupuncture is delivered in clinical practice, a specific syndrome
among a set of possible syndromes for that particular Western disease
is being addressed in the patient’s condition. And the treatment
principle and point selection are dependent on that particular syndrome.
Not only that, but point selections are often, if not always, individualized
to the patient’s particular condition at the time of treatment, which
may differ from another patient who presents with the same disease and
syndrome but also presents with accompanying symptoms or who is different
in age, vitality or has a different type of constitution. Side-effects:
One of the well-known benefits of acupuncture is the relatively few side-effects
experienced by the patient. Some common side-effects, as mentioned in
some of the studies, are temporary soreness around the point needled (sometimes
lasting a few hours) and occasional hematoma at the site of needle insertion.
Rarely, faintness, dizziness, headache or muscle tension is reported.
This stands in contrast to the many and sometimes severe side-effects
of pharmaceutical anti-inflammatory agents, NSAIDS, peripheral analgesics
or anti-depressants commonly used in treatment of these conditions. Future
studies: These controlled trials presented offer much evidence of the
efficacy of acupuncture in treating chronic musculoskeletal disorders,
however, much more research remains to be done. Future trials should include
the use of proper controls, randomization, single-blind or double-blind
methods, multiple subjective and objective outcome measures, consider
baseline levels for the outcomes, offer longer follow-up assessment and
statistical analysis, and provide larger study size so that greater power
can be achieved in the studies. Musculoskeletal pain is so common and
has such an impact on the community that we must find funding for large
scale, methodologically sound trials of this simple, relatively safe and
potentially efficacious treatment.
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