Fibromyalgia Treatment Trial With Gabapentin and Osteopathic Manipulative Medicine

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Good Samaritan Regional Medical Center, Oregon
• Collaborator: Touro University,Vallejo,California
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

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.