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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. References 1. Bennett RM. Fibromyalgia: the commonest cause of widespread pain. Compr Ther. 1995;21(6):269-275. 2. Freundlich B, Leventhal L. Diffuse pain syndromes: signs and symptoms of musculoskeletal disorders. In: Klippel JH, ed. Primer on Rheumatic Diseases. Atlanta, Ga: Arthritis Foundation; 1997;123-127. Gamber et al • Original contribution Relieves pain Helps activities of daily living Has positive effect Relieves tender points Negative contribution Positive contribution Medication alone Medication and moist heat Medication and manipulation Medication, manipulation, and teaching 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 ORIGINAL CONTRIBUTION 14. Deluze C, Bosia L, Zirbs A, Chantraine A, Vischer TL. Electroacupuncture in fibromyalgia: results of a controlled trial. BMJ. 1992;305(6864):1249-1252. 15. Nielson WR, Walker C, McCain GA. Cognitive behavioral treatment of fibromyalgia syndrome: preliminary findings. J Rheumatol. 1992;19(1):98- 103. 16. Rubin B. Rheumatology. In: Ward RC, ed. Foundations for Osteopathic Medicine. Baltimore, Md: Williams & Wilkins; 1997; 459-466. 17. Blunt KL, Rajwani MH, Guerriero RC. The effectiveness of chiropractic man-agement of fibromyalgia patients: a pilot study. J Manipulative Physiol Ther. 1997;20(6):389-399. 18. Dardzinski J, Ostrov B, Hamann L. Myofascial pain unresponsive to stan-dard treatment: successful use of a strain and counterstrain technique with physical therapy. J Clin Rheumatol. 2000;6(4):169-175. 19. White KP, Harth M. An analytical review of 24 controlled clinical trials for fibromyalgia syndrome (FMS). Pain. 1996;64(2):211-219. 20. Rossy LA, Buckelew SP, Dorr N, Hagglund KJ, Thayer JF, McIntosh MJ, Hewett JE, Johnson JC. A meta-analysis of fibromyalgia treatment inter-ventions. Ann Behav Med. 1999;21(2):180-191. 21. Koes BW, Assendelft WJ, van der Heijden GJ, Bouter LM, Knipschild PG. Spinal manipulation and mobilisation for back and neck pain: a blinded review. BMJ. 1991;303(6813):1298-1303. 22. Anderson R, Meeker WC, Wirick BE, Mootz RD, Kirk DH, Adams A. A meta-analysis of clinical trials of spinal manipulation. J Manipulative Physiol Ther. 1992;15(3):181-194. 23. White KP, Speechley M, Harth M, Ostbye T. The London Fibromyalgia Epi-demiology Study: direct health care costs of fibromyalgia syndrome in London, Canada. J Rheumatol. 1999;26(4):885-889. 24. Bennett RM. Multidisciplinary group programs to treat fibromyalgia patients. Rheum Dis Clin North Am. 1996;22(2):351-367. 3. Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and char-acteristics of fibromyalgia in the general population. Arthritis Rheum. 1995; 38(1):19-28. 4. Wolfe F, Ross K, Anderson J, Russell IJ. Aspects of fibromyalgia in the gen-eral population: sex, pain threshold, and fibromyalgia symptoms. J Rheumatol. 1995;22(1):151-156. 5. White KP, Nielson WR. Cognitive behavioral treatment of fibromyalgia syn-drome: a followup assessment. J Rheumatol. 1995;22(4):717-721. 6. Berman BM, Swyers JP. Complementary medicine treatments for fibromyalgia syndrome. Baillieres Best Pract Res Clin Rheumatol 1999;13(3):487- 492. 7. Wolfe F, Hawley DJ. Psychosocial factors and the fibromyalgia syndrome. Z Rheumatol. 1998;57(Suppl 2):88-91. 8. Barsky AJ, Borus JF. Functional somatic syndromes. Ann Intern Med. 1999; 130(11):910-921. 9. Hannonen P, Malminiemi K, Yli-Kerttula U, Isomeri R, Roponen P. A ran-domized, double-blind, placebo-controlled study of moclobemide and amitriptyline in the treatment of fibromyalgia in females without psychiatric disorder. Br J Rheumatol. 1998;37(12):1279-1286. 10. Mengshoel AM, Komnaes HB, Forre O. The effects of 20 weeks of phys-ical fitness training in female patients with fibromyalgia. Clin Exp Rheumatol. 1992;10(4):345-349. 11. McCain GA. Role of physical fitness training in the fibrositis/fibromyalgia syndrome. Am J Med. 1986;81(3A):73-77. 12. McCain GA, Bell DA, Mai FM, Halliday PD. A controlled study of the effects of a supervised cardiovascular fitness training program on the man-ifestations of primary fibromyalgia. Arthritis Rheum. 1988;31(9):1135-1141. 13. Ferraccioli G, Ghirelli L, Scita F, Nolli M, Mozzani M, Fontana S, et al. EMG-biofeedback training in fibromyalgia syndrome. J Rheumatol. 1987; 14(4):820-825. Gamber et al • Original contribution
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Transcript | 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. References 1. Bennett RM. Fibromyalgia: the commonest cause of widespread pain. Compr Ther. 1995;21(6):269-275. 2. Freundlich B, Leventhal L. Diffuse pain syndromes: signs and symptoms of musculoskeletal disorders. In: Klippel JH, ed. Primer on Rheumatic Diseases. Atlanta, Ga: Arthritis Foundation; 1997;123-127. Gamber et al • Original contribution Relieves pain Helps activities of daily living Has positive effect Relieves tender points Negative contribution Positive contribution Medication alone Medication and moist heat Medication and manipulation Medication, manipulation, and teaching 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 ORIGINAL CONTRIBUTION 14. Deluze C, Bosia L, Zirbs A, Chantraine A, Vischer TL. Electroacupuncture in fibromyalgia: results of a controlled trial. BMJ. 1992;305(6864):1249-1252. 15. Nielson WR, Walker C, McCain GA. Cognitive behavioral treatment of fibromyalgia syndrome: preliminary findings. J Rheumatol. 1992;19(1):98- 103. 16. Rubin B. Rheumatology. In: Ward RC, ed. Foundations for Osteopathic Medicine. Baltimore, Md: Williams & Wilkins; 1997; 459-466. 17. Blunt KL, Rajwani MH, Guerriero RC. The effectiveness of chiropractic man-agement of fibromyalgia patients: a pilot study. J Manipulative Physiol Ther. 1997;20(6):389-399. 18. Dardzinski J, Ostrov B, Hamann L. Myofascial pain unresponsive to stan-dard treatment: successful use of a strain and counterstrain technique with physical therapy. J Clin Rheumatol. 2000;6(4):169-175. 19. White KP, Harth M. An analytical review of 24 controlled clinical trials for fibromyalgia syndrome (FMS). Pain. 1996;64(2):211-219. 20. Rossy LA, Buckelew SP, Dorr N, Hagglund KJ, Thayer JF, McIntosh MJ, Hewett JE, Johnson JC. A meta-analysis of fibromyalgia treatment inter-ventions. Ann Behav Med. 1999;21(2):180-191. 21. Koes BW, Assendelft WJ, van der Heijden GJ, Bouter LM, Knipschild PG. Spinal manipulation and mobilisation for back and neck pain: a blinded review. BMJ. 1991;303(6813):1298-1303. 22. Anderson R, Meeker WC, Wirick BE, Mootz RD, Kirk DH, Adams A. A meta-analysis of clinical trials of spinal manipulation. J Manipulative Physiol Ther. 1992;15(3):181-194. 23. White KP, Speechley M, Harth M, Ostbye T. The London Fibromyalgia Epi-demiology Study: direct health care costs of fibromyalgia syndrome in London, Canada. J Rheumatol. 1999;26(4):885-889. 24. Bennett RM. Multidisciplinary group programs to treat fibromyalgia patients. Rheum Dis Clin North Am. 1996;22(2):351-367. 3. Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and char-acteristics of fibromyalgia in the general population. Arthritis Rheum. 1995; 38(1):19-28. 4. Wolfe F, Ross K, Anderson J, Russell IJ. Aspects of fibromyalgia in the gen-eral population: sex, pain threshold, and fibromyalgia symptoms. J Rheumatol. 1995;22(1):151-156. 5. White KP, Nielson WR. Cognitive behavioral treatment of fibromyalgia syn-drome: a followup assessment. J Rheumatol. 1995;22(4):717-721. 6. Berman BM, Swyers JP. Complementary medicine treatments for fibromyalgia syndrome. Baillieres Best Pract Res Clin Rheumatol 1999;13(3):487- 492. 7. Wolfe F, Hawley DJ. Psychosocial factors and the fibromyalgia syndrome. Z Rheumatol. 1998;57(Suppl 2):88-91. 8. Barsky AJ, Borus JF. Functional somatic syndromes. Ann Intern Med. 1999; 130(11):910-921. 9. Hannonen P, Malminiemi K, Yli-Kerttula U, Isomeri R, Roponen P. A ran-domized, double-blind, placebo-controlled study of moclobemide and amitriptyline in the treatment of fibromyalgia in females without psychiatric disorder. Br J Rheumatol. 1998;37(12):1279-1286. 10. Mengshoel AM, Komnaes HB, Forre O. The effects of 20 weeks of phys-ical fitness training in female patients with fibromyalgia. Clin Exp Rheumatol. 1992;10(4):345-349. 11. McCain GA. Role of physical fitness training in the fibrositis/fibromyalgia syndrome. Am J Med. 1986;81(3A):73-77. 12. McCain GA, Bell DA, Mai FM, Halliday PD. A controlled study of the effects of a supervised cardiovascular fitness training program on the man-ifestations of primary fibromyalgia. Arthritis Rheum. 1988;31(9):1135-1141. 13. Ferraccioli G, Ghirelli L, Scita F, Nolli M, Mozzani M, Fontana S, et al. EMG-biofeedback training in fibromyalgia syndrome. J Rheumatol. 1987; 14(4):820-825. Gamber et al • Original contribution |
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