Fibromyalgia Treatment Trial With Gabapentin and Osteopathic Manipulative Medicine
NCT ID: NCT01107574
Last Updated: 2013-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
41 participants
INTERVENTIONAL
2004-04-30
2010-04-30
Brief Summary
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Detailed Description
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The primary outcome measures were measured during week 2 and week 8 to evaluate efficacy of each arm and compare efficacy between each arm at improving structure, function and pain. The Baker Wong Brief Pain Inventory (BPI) was evaluated weekly for average pain severity score (range 0-10, where 0 = no pain and 10 = pain as bad as you can imagine). Fibromyalgia Impact Questionnaire (FIQ) a tool that evaluates function and health status was administered at week 2 and week 8 for comparison of functioning at the baseline and end of the study. The total number of Tender Points (0-18) as determined by the American College of Rheumatology was counted at week 2 and week 8 to compare number of tender points from the baseline to the end. Dolorimetry in Kg/cm2 as measured by the Fischer Dolorimeter were measured on the 4 most severe tender points at week 2 and week 8 to compare severity of tender points from baseline to end of study. The Osteopathic Structural Examination which measures free range of motion of joints in degrees was measured with goniometry at week 2 and week 8 to evaluate degrees of free range of motion improved from baseline. The Clinical Global Impression which is a likert scale of 1-5 asking patients to evaluate how they feel about their overall health was taken at week 2 and week 8 to see if overall subjective thoughts of health were improved from baseline.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Gabapentin and Osteopathic Manipulative Medicine
6 weeks of both Gabapentin 900 mg HS given orally was accompanied with Osteopathic Manipulative Medicine treatment 30 minutes weekly to the tender points of the musculoskeletal system of each patient for 6 weeks.
Gabapentin and Osteopathic Manipulative Medicine
Combination therapy of gabapentin 900 mg po HS for 6 weeks and Osteopathic Manipulative Medicine 30 minute treatment weekly for each patient based on Osteopathic Structural Examination and Tender point Examination
Gabapentin
Gabapentin was given orally at 900 mg at HS weekly for 6 weeks.
Gabapentin
Gabapentin 900 mg po HS for 6 weeks treatment per patients enrolled in the Gabapentin Arm
Osteopathic Manipulative Medicine
6 weeks of Osteopathic Manipulative Medicine Treatment was applied to the patients tender points in the musculoskeletal system weekly by a 30 minute treatment.
Osteopathic Manipulative Medicine
Based on Osteopathic Structural Examination and Tender point Examination a 30 minute treatment of Osteopathic Manipulative Medicine was applied to each patient every week for 6 weeks.
Interventions
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Gabapentin
Gabapentin 900 mg po HS for 6 weeks treatment per patients enrolled in the Gabapentin Arm
Osteopathic Manipulative Medicine
Based on Osteopathic Structural Examination and Tender point Examination a 30 minute treatment of Osteopathic Manipulative Medicine was applied to each patient every week for 6 weeks.
Gabapentin and Osteopathic Manipulative Medicine
Combination therapy of gabapentin 900 mg po HS for 6 weeks and Osteopathic Manipulative Medicine 30 minute treatment weekly for each patient based on Osteopathic Structural Examination and Tender point Examination
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Rheumatoid arthritis, inflammatory arthritis, or autoimmune disease;
* Pain from traumatic injury or structural or regional rheumatic disease;
* Rheumatoid arthritis, inflammatory arthritis, or autoimmune disease;
* Unstable medical or psychiatric illness;
* Lifetime history of psychosis, hypomania or mania, epilepsy, or dementia;
* Substance abuse in the last 6 months;
* Serious risk of suicide;
* Pregnancy or breastfeeding;
* Unacceptable contraception in those of childbearing potential;
* Patients who, in the opinion of the investigator, were treatment refractory; and prior failed treatment with gabapentin, pregabalin or OMM.
18 Years
65 Years
ALL
Yes
Sponsors
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Touro University,Vallejo,California
UNKNOWN
Good Samaritan Regional Medical Center, Oregon
OTHER
Responsible Party
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Cynthia S. Marske DO
Program Director Internal Medicine Residency
Principal Investigators
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Alejandro Gugliucci, MD, PhD
Role: STUDY_DIRECTOR
Touro University-CA, Vallejo
Locations
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Touro University College of Osteoapathic Medicine
Vallejo, California, United States
Countries
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References
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Antai-Otong D. The art of prescribing. Depression and fibromyalgia syndrome (FMS): pharmacologic considerations. Perspect Psychiatr Care. 2005 Jul-Sep;41(3):146-8. doi: 10.1111/j.1744-6163.2005.00028.x. No abstract available.
Arnold LM, Goldenberg DL, Stanford SB, Lalonde JK, Sandhu HS, Keck PE Jr, Welge JA, Bishop F, Stanford KE, Hess EV, Hudson JI. Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum. 2007 Apr;56(4):1336-44. doi: 10.1002/art.22457.
Bennett RM. Emerging concepts in the neurobiology of chronic pain: evidence of abnormal sensory processing in fibromyalgia. Mayo Clin Proc. 1999 Apr;74(4):385-98. doi: 10.4065/74.4.385.
Blunt KL, Rajwani MH, Guerriero RC. The effectiveness of chiropractic management of fibromyalgia patients: a pilot study. J Manipulative Physiol Ther. 1997 Jul-Aug;20(6):389-99.
Gamber RG, Shores JH, Russo DP, Jimenez C, Rubin BR. Osteopathic manipulative treatment in conjunction with medication relieves pain associated with fibromyalgia syndrome: results of a randomized clinical pilot project. J Am Osteopath Assoc. 2002 Jun;102(6):321-5.
Hains G, Hains F. A combined ischemic compression and spinal manipulation in the treatment of fibromyalgia: a preliminary estimate of dose and efficacy. J Manipulative Physiol Ther. 2000 May;23(4):225-30.
Johnson SM, Kurtz ME. Osteopathic manipulative treatment techniques preferred by contemporary osteopathic physicians. J Am Osteopath Assoc. 2003 May;103(5):219-24.
Maizels M, McCarberg B. Antidepressants and antiepileptic drugs for chronic non-cancer pain. Am Fam Physician. 2005 Feb 1;71(3):483-90.
McCleane G. Gabapentin reduces chronic benign nociceptive pain: a double-blind, placebo-controlled cross-over study. The Pain Clinic. 2000; 12(2):81-85.
Noller V, Sprott H. Prospective epidemiological observations on the course of the disease in fibromyalgia patients. J Negat Results Biomed. 2003 Aug 23;2:4. doi: 10.1186/1477-5751-2-4.
Rivera J, Gonzalez T. The Fibromyalgia Impact Questionnaire: a validated Spanish version to assess the health status in women with fibromyalgia. Clin Exp Rheumatol. 2004 Sep-Oct;22(5):554-60.
Hansen HC. Treatment of chronic pain with antiepileptic drugs: a new era. South Med J. 1999 Jul;92(7):642-9. doi: 10.1097/00007611-199907000-00001.
Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
Related Links
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Department of Research
Other Identifiers
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04-01-2004
Identifier Type: -
Identifier Source: org_study_id