Clinical trial NCT01107574: Fibromyalgia Treatment Trial With Gabapentin and Osteopathic Manipulative Medicine
Official title: Phase III Study of the Use of Gabapentin and Osteopathic Manipulative Medicine to Treat Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Keywords: Chronic Pain, tenderpoints, insomnia, mood disorder, fatigue
Lead sponsor: Good Samaritan Regional Medical Center, Oregon
Sponsor class: OTHER
Collaborators: name: Touro University,Vallejo,California
First posted: 2010-04-21
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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.

Primary outcomes:
measure: Outcomes of Efficacy and Tolerability by measure of scored visual tools
timeFrame: 8 Weeks
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Vallejo
country: United States
facility: Touro University College of Osteoapathic Medicine
state: California
Study officials:
affiliation: Touro University-CA, Vallejo
name: Alejandro Gugliucci, MD, PhD
role: STUDY_DIRECTOR
References:
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