CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 41 enrolled
Drug / intervention
Gabapentin +2 moredrug
Likely dose
Gabapentin 900 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01107574
NCT01107574Phase 3Completed
CompareCT.gov

Phase III Study of the Use of Gabapentin and Osteopathic Manipulative Medicine to Treat Fibromyalgia

Good Samaritan Regional Medical Center, Oregon·interventional·Posted Apr 21, 2010·Updated Aug 28, 2013

In Brief

A Phase 3 clinical trial evaluating Gabapentin, Osteopathic Manipulative Medicine, and 1 other intervention for Fibromyalgia. Completed, enrolled 41 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
CollaboratorsTouro University,Vallejo,California

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 21, 2010
Enrollment StartApr 1, 2004
Primary CompletionDec 1, 2009
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 16.2 years ago

Interventions

Gabapentindrug

Gabapentin 900 mg po HS for 6 weeks treatment per patients enrolled in the Gabapentin Arm

Osteopathic Manipulative Medicineprocedure

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 Medicineother

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