drugset / Trial / NCT01107574
Fibromyalgia Treatment Trial With Gabapentin and Osteopathic Manipulative Medicine
Phase 3
Completed
41 enrolled
Good Samaritan Regional Medical Center, Oregon
Touro University,Vallejo,California · collab
RandomizedSingle-groupTriple-blindTreatment
Summary
This study assesses the benefits of intervention with gabapentin, Osteopathic Manipulative Medicine or both for improvement of the symptoms of Fibromyalgia. This study also seeks to determine whether these treatments will decrease the number and severity of tender points, improve structure, function and the overall pain level of each patient from the baseline of the study to the end. This study is designed to evaluate whether subjects subjectively experience an improved quality of life and increased function as a result of these interventions corresponding to objective improvements.
Timeline
- Start
- 2004-04
- Primary completion
- 2009-12
- Completion
- 2010-04
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background Johnson SM, Kurtz ME. Osteopathic manipulative treatment techniques preferred by contemporary osteopathic physicians. J Am Osteopath Assoc. 2003 May;103(5):219-24.
- Background Maizels M, McCarberg B. Antidepressants and antiepileptic drugs for chronic non-cancer pain. Am Fam Physician. 2005 Feb 1;71(3):483-90.
- Background McCleane G. Gabapentin reduces chronic benign nociceptive pain: a double-blind, placebo-controlled cross-over study. The Pain Clinic. 2000; 12(2):81-85.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gabapentin | Small molecule | 900 mg | Oral |