Fibromyalgia Clinical Trial
— FTTGOOfficial title:
Phase III Study of the Use of Gabapentin and Osteopathic Manipulative Medicine to Treat Fibromyalgia
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | April 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Female or male patients were eligible for the study if they were 18-65 years of age and met the ACR criteria for fibromyalgia ([1]). Exclusion Criteria: - Patients with other rheumatic or medical disorders that contributed to the symptoms of fibromyalgia were excluded. - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Touro University College of Osteoapathic Medicine | Vallejo | California |
Lead Sponsor | Collaborator |
---|---|
Good Samaritan Regional Medical Center, Oregon | Touro University,Vallejo,California |
United States,
Antai-Otong D. The art of prescribing. Depression and fibromyalgia syndrome (FMS): pharmacologic considerations. Perspect Psychiatr Care. 2005 Jul-Sep;41(3):146-8. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Hansen HC. Treatment of chronic pain with antiepileptic drugs: a new era. South Med J. 1999 Jul;92(7):642-9. Review. — View Citation
Johnson SM, Kurtz ME. Osteopathic manipulative treatment techniques preferred by contemporary osteopathic physicians. J Am Osteopath Assoc. 2003 May;103(5):219-24. — View Citation
Maizels M, McCarberg B. Antidepressants and antiepileptic drugs for chronic non-cancer pain. Am Fam Physician. 2005 Feb 1;71(3):483-90. Review. — View Citation
McCleane G. Gabapentin reduces chronic benign nociceptive pain: a double-blind, placebo-controlled cross-over study. The Pain Clinic. 2000; 12(2):81-85.
Nöller V, Sprott H. Prospective epidemiological observations on the course of the disease in fibromyalgia patients. J Negat Results Biomed. 2003 Aug 23;2:4. — View Citation
Rivera J, González 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. — View Citation
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. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Outcomes of Efficacy and Tolerability by measure of scored visual tools | Efficacy by Wong-Baker Pain Scale, Fibromyalgia Impact questionaire,Osteopathic Structural Exam, Clinical Global Impression of Change, Tenderpoints and Dolorimetry were assessed at week one and week 8 of treatment. | 8 Weeks | Yes |
Secondary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | safety of Osteopathic Manipulative Medicine and Gapapentin by evaluation of treatment reactions weekly and laboratories before and after the study. | 8 weeks | Yes |
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