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ORIGINAL ARTICLES
Blunt et al14 completed a pilot study with a crossover design weight scale to identify the amount of applied thumb pres-
combined with an assessment taken before and after treat- sure corresponding to 4 kg. The assessment included the
ment of the effectiveness of chiropractic management of 21 tender-point sites used to define the presence of fibromyal-
patients with fibromyalgia. The chiropractic intervention gia1 and the trigger-point sites, which were apt to reproduce
was a 4-week course of approximately 10 to 15 treatments pain as reported on the pain intensity questionnaire.16
that included spinal manipulation, soft-tissue therapy, and The 3 evaluated outcomes were measured with patient
passive stretching. Patients in the control group were placed self-administered questionnaires at baseline, after 15 and 30
on a 4-week waiting list before receiving the actual chiro- treatments, and 1 month after the end of the treatment trial.
practic treatments. No statistically significant improvement The primary outcome measure was pain intensity. A set of
was noted; however, the authors determined that the changes 12 visual analog scales (0 to 10) assessing the level of pain
were clinically important and suggested repeating the trial in different body parts, including the head, neck, shoulder,
with a larger sample size. This study does not provide the arm, upper back, shoulder blade, lower back, hip, thigh, calf,
necessary information about dosage. Before conducting a chest, and abdomen, were developed for the purpose of this
randomized clinical trial, it is necessary to estimate the num- study. The quality of sleep and level of fatigue were sec-
ber of treatments that should be given. Furthermore, the ondary measures also evaluated with visual analog scales.
effects of chiropractic care on the quality of sleep and
fatigue have not yet been investigated. Treatment Specification
The first objective of this study was to provide prelimi- Patients underwent a course of 30 treatments 2 to 3 times
nary information on whether a regimen of 30 chiropractic weekly. The first phase of each treatment consisted of apply-
treatments combining ischemic compression and spinal ing ischemic compression to a number of tender points pre-
manipulation effectively reduces the intensity of pain, sleep viously identified by palpation; the technique was developed
disturbance, and fatigue associated with fibromyalgia. The by Travell and Simons16 and used by chiropractors.17-19 A
second objective was to study the dose-response relation and progressively stronger pressure sufficient to reach the patient
identify the baseline characteristics that may serve as pre- pain-tolerance threshold, the limit at which the patient tries
dictors of outcome. to move away or contract the affected muscle as a means of
self-protection, was applied with 2 thumbs on each tender
METHODS point. The digital pressure was sustained for 10 seconds; this
Sample Selection technique was repeated during the following visits until the
Members of the regional Fibromyalgia Association were site was no longer painful on application of 4 kg of digital
invited to participate in this study. To be eligible, the subjects pressure or until the end of the trial.
were required to be aged >18 years, to have widespread pain The second phase of each treatment consisted of providing
for >3 months, and to have previously been diagnosed with spinal manipulative therapy. Spinal manipulation was de-
fibromyalgia by their family physician or rheumatologist. fined as a short-lever, low-amplitude, high-velocity thrust,
Widespread pain was defined according to the American Col- usually accompanied by an audible cracking sound. Palpa-
lege of Rheumatology fibromyalgia criteria as pain in the ax- tion was used to identify the spinal motion segments to be
ial skeleton and in the upper and lower extremities.1 Finally, manipulated. The 2 main criteria used as indication for ma-
subjects were required to complete a consent form to partici- nipulation were a decrease in the quality of segmental motion
pate in the study and to be available for the duration of the trial. and increased tenderness. The manipulations were conducted
A total of 16 subjects volunteered to participate in this in the area of the cervical and thoracic spine with 2 diversi-
study; one subject was excluded because she did not meet the fied techniques. The cervical spine manipulative procedure
entry criterion of widespread pain. The study population con- consisted of a bilateral rotary cervical manipulation with spe-
sisted of 15 women with a mean age of 51.1 years (standard cific contact over the zygapophyseal joints.20 The thoracic
deviation [SD] = 10.4 years). The duration of widespread pain spine manipulation consisted of a posteroanterior thrust with
ranged from 3 to 20 years (mean = 10.1 years; SD = 5.9 years) bilateral thenar contact on adjacent transverse processes.21
although they had been diagnosed with fibromyalgia more re- Lumbar or sacroiliac manipulation was not applied.
cently (mean = 2.2 years, SD = 1.1 years). Visual analog scales
were used to calculate the scores for the 3 outcomes evalu- Method for Controlling Bias
ated. Mean scores were 75.2 of 120 (SD = 15.9) on the pain in- Noncompliance was minimized by the wide range of
tensity scale; 8.1 of 10 (SD = 2.5) on the sleep quality scale; available treatment times and regular follow-up telephone
and 8.5 of 10 on the fatigue scale (SD = 1.5). The mean num- calls to reschedule missed appointments. In addition, patient
ber of clinically identified tender points was 30.3 (SD = 10.6). assessments were conducted with self-administered ques-
tionnaires without the chiropractor present to minimize the
Baseline and Outcome Assessment influence of the subject-clinician relationship.
The baseline chiropractic evaluation consisted of identify-
ing tender-point sites. To be defined as a tender point, a site Statistical Analysis
had to be reported as painful when a thumb pressure of In the absence of a control group, what was considered a
approximately 4 kg was applied.15 The examiner used a clinically significant improvement was defined a priori.
Journal of Manipulative and Physiological Therapeutics 227
Volume 23 • Number 4 • May 2000
Fibromyalgia Trial • Hains and Hains
Respondents Nonrespondents
(n = 9) (n = 6) P value
Age (y) 47.0 ± 9.8 57.3 ± 8.7 .057
Number of tender points 26.2 ± 9.3 36.5 ± 9.8 .061
Duration of illness (y) 8.2 ± 5.4 12.8 ± 6.0 .144
Duration of diagnosis (y) 1.9 ± 1.0 2.7 ± 1.0 .190
Pain intensity (0 - 120)* 70.2 ± 8.7 82.7 ± 21.9 .146
Quality of sleep (0 - 10)* 7.6 ± 3.0 8.8 ± 1.3 .349
Fatigue level (0 -10)* 8.4 ± 1.8 8.7 ± 0.96 .705
Table 2. Visual analogue scale scores for pain intensity, quality of sleep, and fatigue level from baseline to 15- and 30-treatment
assessment and to the 1-month follow-up assessment for each subject
measures was observed for either group between the last continue treatment during the 1-month follow-up period be-
treatment and the 1-month follow-up assessment. cause of a recurrence of the original symptoms. For ethical
The pain intensity scores were significantly different be- reasons, these patients were excluded from the follow-up
tween the respondents and nonrespondents after 15 and 30 section of the study and remained under active care.
treatments and remained so at the 1-month follow-up assess- Previous drug trials with fibromyalgia have reported a
ment (Table 4). The only significant difference in the quality- strong placebo response.15,22,23 The decision to require a
of-sleep score between the 2 groups was noted after 30 treat- minimum 50% improvement after 30 treatments to classify
ments. No significant difference between the 2 groups was subjects as respondents was an attempt to exclude subjects
noted in the fatigue level at any of the assessments. whose response to treatment was more likely to be attributed
to this effect. On its own, such a placebo effect would be
DISCUSSION unlikely to produce the magnitude of improvement noted in
The results of this study suggest that chiropractic care this group of respondents and even less likely to produce a
combining ischemic compression and spinal manipulation sustainable improvement 1 month after the end of the treat-
may help patients with fibromyalgia. A total of 60% of this ment trial. In addition, the more treatment patients received,
sample reported a mean improvement of 77.1% in pain in- the less symptoms they reported. This dose-response rela-
tensity in addition to a 63.5% improvement in the quality of tion supports the hypothesis that the observed improvement
sleep and a 74.8% improvement in fatigue level. The causes may be caused by the physiologic effect of the treatment
of poor quality of sleep and high fatigue levels reported in fi- itself.24
bromyalgia are poorly understood. The observed improve- Cost effectiveness is important when considering the use
ment in this study may suggest that these symptoms were ag- of a new treatment approach. This sample showed a progres-
gravated, at least in part, by the presence of pain. The sive improvement in outcome during the treatment trial, sug-
reduction of pain may have led to the improvement in the gesting that the course of 30 treatments was adequate. The
quality of sleep and fatigue observed in this study. These sustaining of the effect at the 1-month follow-up assessment
symptoms may be part of a vicious cycle caused by pain.6,7 also suggests that this chiropractic approach may have a pro-
The lessening of pain was maintained throughout the fol- longed benefit.
low-up period of 1 month, suggesting that chiropractic care It may also be possible to identify which patients are most
may help patients beyond the actual provision of care. This likely to respond positively to chiropractic care. In our sam-
effect was not observed in the different drug trial, which ple, some not statistically significant trends that warrant
tested the efficacy of amitriptyline and cyclobenzaprine for attention in a larger clinical trial were observed. For
the treatment of fibromyalgia.15 These drugs were not shown instance, older subjects with a more chronic illness and a
to be effective after stopping medication intake. greater intensity of symptoms who have more tender points
Side effects were not monitored during the trial. However, at baseline assessment appeared to respond more poorly to
compliance was excellent, and no patient dropped out of the treatment. In addition, the percent lessening of pain intensity
treatment section of the study. This compliance suggests that after 15 treatments was significantly inferior in the nonre-
patients were satisfied with the care received and did not have spondents. Subjects who showed <35% improvement after
side effects or complications sufficiently intense for them to 15 treatments did not show a satisfactory response after 30
withdraw from the study. The opposite problem was encoun- treatments. This observation suggests that a minimum 35%
tered; two subjects in the nonrespondent group requested to improvement in pain intensity must be observed after 15
Journal of Manipulative and Physiological Therapeutics 229
Volume 23 • Number 4 • May 2000
Fibromyalgia Trial • Hains and Hains
Table 3. Population mean score differences in pain intensity, quality of sleep, and fatigue level after 15 treatments, 30 treatments, and
1-month follow-up compared with the preceding assessment scores
*Paired sample t tests were conducted to determine the statistical significance of the observed changes between each assessment. Individual P values in
this table should be interpreted with caution because of the multiplicity of tests. R, Respondents; NR, nonrespondents.
Table 4. Mean visual analogue scale scores for pain intensity, quality of sleep, and fatigue level at 15-treatment assessment, 30-treatment
assessment, and 1-month follow-up assessment by response status
*Bonferroni adjusted significance level required for the independent sample t tests is P < .003. R, Respondents; NR, nonrespondents.
treatments or it may no longer be appropriate to pursue this ment of a placebo-controlled randomized clinical trial was es-
form of treatment. timated at 50 patients per group to be adequate on the basis of
A selection bias may have occurred because subjects vol- an estimated improvement of 50% in the chiropractic group
unteered to participate in this study and because of the small versus 15% in the placebo group. Future studies should be de-
sample size. However, the baseline characteristics of our signed with 90% power and a 2-tailed test with a significance
subjects were similar to those in another fibromyalgia trial.15 level of .05, assuming a 10% dropout rate in future studies.
The outcome was strictly measured with self-administered
questionnaires to minimize the risk that the physician’s CONCLUSION
expectations might influence the results. Moreover, these This study suggests a potential role for chiropractic care
questionnaires were completed without the clinician present in the management of fibromyalgia. Most subjects with
to limit possible bias related to the desire of the subjects to fibromyalgia appear to have responded favorably to a course
please the clinician and report an inaccurate improvement. of 30 chiropractic treatments including spinal manipulation
Furthermore, fibromyalgia is a chronic illness that rarely and ischemic compression therapy. Fifteen treatments seem
remits, making it unlikely that improvement was related to to be an adequate cutoff point to determine if a significant
the natural history of the condition. Although subjects did improvement in pain has occurred and if further care is war-
not report initiating new forms of treatment during the ranted. Chiropractic care appears to provide benefits for at
course of the trial, collecting data about the usage of med- least 1 month after stopping therapy. A placebo-controlled
ication, exercise, or other forms of therapy to minimize bias- randomized clinical trial is recommended in the near future
es related to cointerventions would have been more appro- to test these hypotheses.
priate. Finally, the baseline assessment should have included
a more rigorous physical and mental health evaluation. For REFERENCES
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Volume 23 • Number 4 • May 2000
Fibromyalgia Trial • Hains and Hains
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