Fibromyalgia Treatment Trial With Gabapentin and Osteopathic Manipulative Medicine (FTTGO)

August 27, 2013 updated by: Cynthia S. Marske DO, Good Samaritan Regional Medical Center, Oregon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Vallejo, California, United States, 94592
        • Touro University College of Osteoapathic Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Combined OMM and Neurontin
Experimental: Gabapentin
Gabapentin was given orally at 900 mg at HS weekly for 6 weeks.
Drug: Gabapentin
Gabapentin 900 mg po HS for 6 weeks treatment per patients enrolled in the Gabapentin Arm
Other Names:
  • 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 Names:
  • Osteopathic Manipulation Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Good Samaritan Regional Medical Center, Oregon

Collaborators

Touro University,Vallejo,California

Investigators

  • Study Director: Alejandro Gugliucci, MD, PhD, Touro University-CA, Vallejo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

April 19, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 21, 2010

Study Record Updates

Last Update Posted (Estimate)

August 28, 2013

Last Update Submitted That Met QC Criteria

August 27, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-01-2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fibromyalgia

Clinical Trials on Gabapentin and Osteopathic Manipulative Medicine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe