Fibromyalgia Treatment Trial With Gabapentin and Osteopathic Manipulative Medicine (FTTGO)
|Fibromyalgia||Drug: Gabapentin Procedure: Osteopathic Manipulative Medicine Other: Gabapentin and Osteopathic Manipulative Medicine||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase III Study of the Use of Gabapentin and Osteopathic Manipulative Medicine to Treat Fibromyalgia|
- Outcomes of Efficacy and Tolerability by measure of scored visual tools [ Time Frame: 8 Weeks ]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.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ]safety of Osteopathic Manipulative Medicine and Gapapentin by evaluation of treatment reactions weekly and laboratories before and after the study.
|Study Start Date:||April 2004|
|Study Completion Date:||April 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: 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.
Other: 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 Name: Combined OMM and Neurontin
Gabapentin was given orally at 900 mg at HS weekly for 6 weeks.
Gabapentin 900 mg po HS for 6 weeks treatment per patients enrolled in the Gabapentin Arm
Other Name: Neurontin
Experimental: 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.
Procedure: 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.
Other Name: Osteopathic Manipulation Treatment
An 8-week, randomized, study was designed to compare gabapentin (900 mg/day) (n = 8 patients) with OMM (n = 11 patients) with Combined treatment of gabapentin (900 mg/day) plus OMM (n = 7 patients) for efficacy and safety in treating pain, fatigue, depression and function associated with fibromyalgia.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107574
|United States, California|
|Touro University College of Osteoapathic Medicine|
|Vallejo, California, United States, 94592|
|Study Director:||Alejandro Gugliucci, MD, PhD||Touro University-CA, Vallejo|