Osteopathic manipulative treatment in conjunction with medication relieves pain associated with fibromyalgia syndrome: results of a randomized clinical pilot project [review; review, tutorial] [see comments]

              Gamber et al • Original contribution JAOA • Vol 102 • No 6 • June 2002 • 321
Osteopathic physicians caring for patients with fibro-myalgia
syndrome (FM) often use osteopathic manipu-lative
treatment (OMT) in conjunction with other forms of
standard medical care. Despite a growing body of evi-dence
on the efficacy of manual therapy for the treatment
of selected acute musculoskeletal conditions, the role of
OMT in treating patients with chronic conditions such
as FM remains largely unknown.
Twenty-four female patients meeting American Col-lege
of Rheumatology criteria for FM were randomly
assigned to one of four treatment groups: (1) manipulation
group, (2) manipulation and teaching group, (3) moist
heat group, and (4) control group, which received no addi-tional
treatment other than current medication. Partici-pants’
pain perceptions were assessed by use of pain
thresholds measured at each of 10 bilateral tender points
using a 9-kg dolorimeter, the Chronic Pain Experience
Inventory, and the Present Pain Intensity Rating Scale.
Patients’ affective response to treatment was assessed
using the Self-Evaluation Questionnaire. Activities of
daily living were assessed using the Stanford Arthritis
Center Disability and Discomfort Scales: Health Assess-ment
Questionnaire. Depression was assessed using the
Center for Epidemiological Studies Depression Scale.
Significant findings between the four treatment
groups on measures of pain threshold, perceived pain,
attitude toward treatment, activities of daily living, and per-ceived
functional ability were found. All of these findings
favored use of OMT. This study found OMT combined
with standard medical care was more efficacious in treating
FM than standard care alone. These findings need to be
replicated to determine if cost savings are incurred when
treatments for FM incorporate nonpharmacologic ap-proaches
such as OMT.
(Key words: osteopathic manipulative treatment,
orthopedic manipulation, fibromyalgia, clinical trials)
Fibromyalgia (FM) syndrome is a common nonarticular,
rheumatic musculoskeletal pain disorder for which a
definite cause has yet to be identified.1 Diffuse muscu-loskeletal
pain and aching, the presence of multiple tender
points (TP), disturbed sleep, fatigue, and morning stiffness
characterize the syndrome. Central to the American College
of Rheumatology’s FM diagnostic criteria are the presence of
reproducible TPs on physical examination. These TPs must
be located in all four quadrants of the body, including the
axial skeleton, and must elicit pain—not mere subjective dis-comfort
or tenderness—to palpation with a force of 4 kg.2
Approximately 10% to 12% of the general population
suffers from chronic pain, and FM is the second most
common diagnosis in rheumatology clinics.3 Fibromyalgia
syndrome appears to be more common in women and
exhibits increasing prevalence as a function of age and comor-bidity.
4 Medical service use and disability rates are high
among patients in whom fibromyalgia is diagnosed.5 Simi-larly,
use of a variety of complementary and alternative
modes of therapy also appears to be common among patients
with FM.6
The prevalence of psychiatric symptoms among patients
in whom FM is diagnosed is high. A lifetime history of
depression has been reported in up to 70% of patients with
FM.7 Psychological stress has been shown to exacerbate the
expression of primary FM symptoms. Moreover, it appears
that FM is often associated with several other recently
described “functional somatic syndromes” such as irritable
bowel syndrome, chronic fatigue syndrome, and multiple
chemical sensitivity.8
Medication therapy, including the use of antidepres-sants
and nonsteroidal anti-inflammatory drugs, has been the
mainstay of treatment for FM. Of these pharmacologic inter-ventions,
tricyclic antidepressants, such as amitriptyline
hydrochloride, have been the most widely studied and eval-uated.
In general, use of these medications has resulted in
relief of symptoms, but these benefits are modest and
decrease over time.9 Nonpharmacologic approaches,
including fitness training programs,10-12 biofeedback,13 elec-
ORIGINAL CONTRIBUTION
Osteopathic manipulative treatment in conjunction with medication relieves pain
associated with fibromyalgia syndrome: Results of a randomized clinical pilot project
RUSSELL G. GAMBER, DO; JAY H. SHORES, PHD; DAVID P. RUSSO, BA; CYNTHIA JIMENEZ, RN; BENARD R. RUBIN, DO
Dr Gamber is an associate professor in the Department of Osteopathic Manip-ulative
Medicine, Texas College of Osteopathic Medicine, University of North
Texas Health Science Center at Fort Worth, Fort Worth, Texas, where Mr
Russo is a predoctoral research fellow; Dr Shores is an associate professor in
the Department of Medical Education; Ms Jimenez is a research nurse in the
Division of Rheumatology; and Dr Rubin is a professor in the Division of
Rheumatology.
Research supported by the American Osteopathic Association Bureau of
Research.
Address correspondence to Russell G. Gamber, DO, University of North
Texas Health Science Center, 3500 Camp Bowie Blvd, Fort Worth, TX 76107.
E-mail: rgamber@hsc.unt.edu
322 • JAOA • Vol 102 • No 6 • June 2002
ORIGINAL CONTRIBUTION
troacupuncture,14 and cognitive-behavioral psychotherapy,15
have demonstrated some overall efficacy.
Osteopathic physicians involved in the care of patients
with FM often use osteopathic manipulative treatment (OMT)
in conjunction with standard medical care. Despite a growing
body of evidence on the efficacy of manual therapy for the
treatment of selected acute musculoskeletal conditions, the
role of OMT in treating chronic conditions such as FM
remains largely unknown. Manual modes of therapy such as
OMT have been promoted as therapeutic options for chronic
rheumatic diseases on theoretical grounds,16 but rigorously
controlled studies are lacking. One pilot study of the effec-tiveness
of chiropractic management on FM symptoms
demonstrated improved cervical and lumbar range of motion
but failed to effect any of the primary clinical signs and
symptoms defining FM, such as reduction in TP burden,
overall pain, or perceived functional ability.17 Another ret-rospective
case study review of 20 patients with FM unre-sponsive
to standard treatment showed immediate benefit in
terms of decreased pain and increased function from strain-counterstrain
techniques, a common form of OMT.18
The purpose of the present study was to assess the effi-cacy
of OMT as an adjunct to standard medical care in a
university clinic–based population of rheumatology patients
in whom FM was diagnosed. Of particular interest was the
question of what effect OMT might have on functional out-comes
and psychological well-being. These therapeutic end-points
have been documented as missing in previous ran-domized
clinical trials (RCT) for fibromyalgia.19
Methods
Experimental design
This was a randomized, observer-masked, placebo-controlled
clinical trial of OMT in patients in whom FM was diagnosed
who received medical care in a university-based rheuma-tology
clinic at the University of North Texas Health Science
Center in Fort Worth, Texas. The study assessed all outcomes
using a repeated-measures design. The clinic is a training site
for osteopathic medical students and internal medicine resi-dents
at the University of North Texas Health Science Center
and a regional referral center for patients requiring specialized
management of rheumatic and musculoskeletal diseases. The
institutional review board of the University of North Texas
Health Science Center approved all procedures and inter-ventions
used in this study.
Study population
Participants in this study were patients presenting to the
rheumatology clinics at the University of North Texas Health
Science Center in Fort Worth, Texas. A research technician
screened all patients and offered admission to those who met
the following criteria: (1) a diagnosis of FM based on the 1990
American College of Rheumatology criteria for FM; (2) absence
of concurrent illnesses of consequence (eg, peptic ulcer disease,
cardiac arrythmias, disease requiring CNS suppression); (3)
aged between 30 and 65 years old; (4) no concurrent partici-pation
in other physical or manual modalities such as thera-peutic
massage, chiropractic services, physical therapy, or
OMT with a concurrent physician. A research coordinator
reviewed medical records to confirm study eligibility and
obtained verbal and written informed consent. As part of
their participation in this study, patients received free medical
treatment and laboratory tests related to their FM for the dura-tion
of the 6-month study as well as a $100 stipend to defray
travel expenses.
Randomization and interventions
Precoded cards in sealed envelopes were used to randomly
allocate 24 female patients to one of four treatment groups: (1)
manipulation group receiving OMT; (2) manipulation and
teaching group receiving OMT in addition to instruction at
every visit on how to self-treat their TPs at home; (3) moist heat
group receiving moist heat packs applied to their most trou-blesome
TPs on each physician visit; and (4) control group
receiving only their current medication.
All participants remained on any medications prescribed
to them before enrollment in the study and met with two
physicians on each visit to discuss medication management
and general medical concerns. Both the study rheumatolo-gist
and the study OMT specialist were encouraged to discuss
medical problems and medication management issues with all
enrolled patients. On each visit, subjects received identical
clinical assessments conducted by a trained research nurse-spe-cialist
unaware of participant group assignment. A single
OMT specialist delivered all manipulative interventions.
Manipulative treatments were done according to the fol-lowing
guidelines: (1) one treatment per week, (2) 15 to 30
minutes in duration, and (3) a combination of Jones strain/coun-terstrain
techniques and other osteopathic modalities applied
to those TPs the patient identified as most troublesome. Other
modalities available to the treating physician at his discretion
included myofascial release, muscle energy, soft tissue treat-ment,
and craniosacral manipulation. These techniques all
represent well-accepted modalities within the osteopathic
profession. Treatment was individualized with respect to
sequence and number of modalities used per session because
it is generally accepted that patients may have differential
responses to a given technique.
Measures and outcomes
This study used a control group and repeated-measures design
in which all of the participants were assessed on weeks 1, 2,
4, 7, 11, 15, 19, and 23. The participants were assessed in sev-eral
ways. Pain thresholds were measured at each of 10 bilat-eral
TPs using a 9-kg dolorimeter. Pain indices were obtained
using the Chronic Pain Experience Inventory and the Present
Pain Intensity Rating Scale (PPI). The Chronic Pain Experience
Inventory is an instrument comprising visual-analog Likert
Gamber et al • Original contribution
JAOA • Vol 102 • No 6 • June 2002 • 323
ORIGINAL CONTRIBUTION
36 mitigated against the moist heat group, and 10 mitigated
against the control group in favor of the manipulation group.
A two-way ANOVA of the single measure of pain pro-vided
by the PPI Rating Scale and Center for Epidemiological
Studies Depression Scale resulted in no significant main effect
findings.
Results
All patients completed the study. Significant findings were
found between the four treatment groups on measures of
pain threshold, perceived pain, attitude toward treatment,
activities of daily living, and chronic pain attributes. All of
these findings favored the patients’ receiving OMT. Patients
assigned to one of the two manipulated groups had signifi-cantly
higher pain thresholds at the left and right second cos-tochondral
junction and the left medial epicondyle TPs postin-tervention.
They were significantly more satisfied, more
comfortable, more relaxed as well as less strained, and less con-fused
compared to patients not receiving OMT. They were also
better able to stand alone, cut meat, open a milk carton, walk,
open doors, open jars, turn faucets, go shopping, and get in and
out of a car compared to control subjects who did not receive
OMT. Moreover, they reported fewer symptoms related to
failure, frustration, inhibition, struggling, helplessness, guilt,
incapacity, wakefulness, and tiredness associated with pain.
They were significantly more likely to endorse items indi-cating
that they felt less bothered, had good appetites more
often, were less frequently depressed, had less frequent losses
of energy, were less often restless, and were less often lonely.
The Figure presents a summary of the findings of this study
that may aid in clinical interpretation. It is a frequency polygon
in which each positive finding is weighted  1 and each neg-ative
finding is weighted  1.
Comment
This study found that OMT combined with standard medical
care was more efficacious in the treatment of FM than standard
care alone. If the Figure is treated as a model of the effects of
clinical treatment on patient outcomes, then the relative con-tribution
of the treatments to outcomes is clearly seen. Med-ication
alone sometimes made a contribution to the relief of
pain. Medication with manipulation contributed to pain relief.
Similarly, the addition of teaching patients OMT sometimes
contributed. Moist heat, however, did not contribute to pain
relief. An identical pattern of contribution is seen in the
patients’ activities of daily living. Again, medication with
manipulation contributed to pain relief, whereas medication
with combined manipulation and teaching, and medication
alone occasionally contributed. Moist heat did not contribute
to increases in the activities of daily living. Contributors to
feelings of well-being (“has positive affect”) were medication
alone and medication with moist heat. Neither medicine with
OMT nor medicine with OMT and teaching contributed to this
outcome measure. Thus, it may be inferred that OMT offered
scales assessing the current status of 24 specific affective
attributes of pain. The PPI is a single-item anchored scale
assessing current overall pain at six levels of severity. Affec-tive
response to treatment was assessed using the Self-Eval-uation
Questionnaire (SEQ). The SEQ is an instrument com-prising
anchored four-point scales assessing the participant’s
current status on each of 20 affective attributes. Activities of
daily living were assessed using the Stanford Arthritis Center
Disability and Discomfort Scales: Health Assessment Ques-tionnaire
(HAQ). The HAQ is an instrument comprising
anchored four-point scales assessing the subject’s ability to
perform 20 activities of daily living. Depression was assessed
using the Center for Epidemiological Studies Depression Scale.
The Center for Epidemiological Studies Depression Scale is an
instrument comprising reports on the frequency of occur-rence
of 20 specific psychological attributes related to pain.
Statistical analysis
A two-way (occasion by group) analysis of variance (ANOVA)
was performed on the pain threshold data to test for differences
among the treated and untreated subjects. A significant (P 
.05) group effect was found for 3 of the 20 tender points. Sub-sequent
analyses were run to identify differences among the
four groups using Sheffe’s post hoc contrasts (P .01). Five of
the contrasts favored the manipulation and teaching group, 5
favored the manipulation group, and 1 favored the moist heat
group. Two of the contrasts mitigated against the heat treat-ment
group, and 9 mitigated against the untreated group.
A two-way ANOVA was performed on data obtained
from the SEQ. A significant (P .05) group effect was found
for 5 of the 20 affective attributes. Subsequent Sheffe’s post hoc
contrasts identified significant (P   .01) differences among
the four groups. Ten of the contrasts favored the manipulation
and teaching group, and 14 favored the manipulation group.
Five of the contrasts mitigated against the heat treatment
group, and 11 mitigated against the untreated group.
A two-way ANOVA was performed on the HAQ. A sig-nificant
(P .05) group effect was found for 9 of the 20 activ-ities
of daily living. Subsequent Sheffe’s post hoc contrasts
found significant (P   .01) differences among the groups.
Five of the contrasts favored the manipulation and teaching
group, 26 favored the manipulation group, and 6 favored the
control group. Eight of the contrasts mitigated against the
manipulation and teaching group in favor of the manipulation
group, 23 mitigated against the moist heat group, and 6 mit-igated
against the control group.
A two-way ANOVA was performed on the CPI data. A
significant (P   .05) group effect was found for 11 of the 24
attributes. Subsequent Sheffe’s post hoc contrasts identified sig-nificant
(P   .01) differences among the four groups. Eleven
of the contrasts favored the manipulation and teaching group,
31 favored the manipulation group, and 12 favored the con-trol
group. Eight of the contrasts mitigated against the manip-ulation
and teaching group in favor of the manipulation group,
Gamber et al • Original contribution
324 • JAOA • Vol 102 • No 6 • June 2002
ORIGINAL CONTRIBUTION
more to patients than simple nonspecific effects such as sat-isfaction
with treatment or effects only attributable to ele-ments
of the physician-patient relationship. Both forms of
manipulation (with and without teaching) combined with
medication significantly increased patients’ threshold to pain
at TPs. Medication alone and medication with moist heat did
not contribute to this outcome measure.
In this study, OMT also appeared to affect other symp-toms
associated with FM in a variety of ways. Use of OMT
raised pain thresholds, improved comfort levels and affec-tive
components related to chronic illness, and increased the
perceived functional abilities of treated patients. This finding
contrasts those in a recent metanalysis of 49 FM treatment
outcome studies, which showed that physically-based treat-ments,
such as exercise therapy and prescribed home stretching
regimens, did not significantly improve daily functioning.20
Explanations for differences in daily functioning outcomes
between physically-based treatments such as OMT and exer-cise
therapy are unclear.
The methodologic aspects of our study were evaluated by
adapting two sets of criteria for assessing the quality of RCTs
of spinal manipulation for low back or neck pain.21,22 Scores of
59 and 90 were achieved for the present study using the cri-teria
of Koes et al21 and Anderson et al,22 respectively. This
study addressed a weakness identified in previous RCTs for
FM by measuring functional and psychological variables and
incorporating the use of well-validated data collection instru-ments.
19
The prevalence of FM in the general population is esti-mated
at 2% to 12%.4 If that estimated prevalence is accurate,
then the cost to our economy in lost work time may exceed the
cost of many better-documented illnesses.23 There is an
emerging consensus that the most effective disease manage-ment
programs for FM are multimodal and incorporate a
blend of treatment strategies targeting both physical and psy-chological
aspects of the syndrome.24 Future investigations
with larger sample sizes at multiple centers are needed to
determine if cost savings are incurred when treatments for FM
incorporate nonpharmacologic approaches such as OMT.
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Gamber et al • Original contribution
Relieves pain
Helps activities
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Has positive effect
Relieves tender points
Negative
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Positive
contribution
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Figure. Histogram of the frequency of significant findings by treatment and outcome measure. Frequency polygon with positive findings weighted
 1 and negative findings weighted  1. Combined medication and manipulation and combined medication, manipulation, and teaching improved
perceptions of pain, activities of daily living, and relieved tender points. Medication alone did not relieve tender points.
JAOA • Vol 102 • No 6 • June 2002 • 325
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