Fibromyalgia Treatment Trial With Gabapentin and Osteopathic Manipulative Medicine
CompletedPhase 3NCT01107574
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
- Official title
- Phase III Study of the Use of Gabapentin and Osteopathic Manipulative Medicine to Treat Fibromyalgia
- Conditions
- Interventions
- Drug: Gabapentin
- Procedure: Osteopathic Manipulative Medicine
- Other: Gabapentin and Osteopathic Manipulative Medicine
- Sponsor
- Good Samaritan Regional Medical Center, Oregon
- Collaborators
- Touro University,Vallejo,California
- Start date
- 2004-04
- Primary completion
- 2009-12
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01107574