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Fibromyalgia Treatment Trial With Gabapentin and Osteopathic Manipulative Medicine

NCT01107574 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2013-08-28

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

Interventions

DRUG

Gabapentin

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

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

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

Sponsors & Collaborators

  • Touro University,Vallejo,California

    collaborator UNKNOWN

  • Good Samaritan Regional Medical Center, Oregon

    lead OTHER

Principal Investigators

  • Alejandro Gugliucci, MD, PhD · Touro University-CA, Vallejo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2009-12-31
Completion
2010-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01107574 on ClinicalTrials.gov