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

This study has been completed.
Sponsor:
Collaborator:
Touro University,Vallejo,California
Information provided by (Responsible Party):
Cynthia S. Marske DO, Good Samaritan Regional Medical Center, Oregon
ClinicalTrials.gov Identifier:
NCT01107574
First received: April 19, 2010
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Drug: Gabapentin
Procedure: Osteopathic Manipulative Medicine
Other: Gabapentin and Osteopathic Manipulative Medicine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of the Use of Gabapentin and Osteopathic Manipulative Medicine to Treat Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Good Samaritan Regional Medical Center, Oregon:

Primary Outcome Measures:
  • Outcomes of Efficacy and Tolerability by measure of scored visual tools [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    safety of Osteopathic Manipulative Medicine and Gapapentin by evaluation of treatment reactions weekly and laboratories before and after the study.


Enrollment: 41
Study Start Date: April 2004
Study Completion Date: April 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Osteopathic Manipulation 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107574

Locations
United States, California
Touro University College of Osteoapathic Medicine
Vallejo, California, United States, 94592
Sponsors and Collaborators
Good Samaritan Regional Medical Center, Oregon
Touro University,Vallejo,California
Investigators
Study Director: Alejandro Gugliucci, MD, PhD Touro University-CA, Vallejo
  More Information

Additional Information:
Publications:

Responsible Party: Cynthia S. Marske DO, Program Director Internal Medicine Residency, Good Samaritan Regional Medical Center, Oregon
ClinicalTrials.gov Identifier: NCT01107574     History of Changes
Other Study ID Numbers: 04-01-2004
Study First Received: April 19, 2010
Last Updated: August 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Good Samaritan Regional Medical Center, Oregon:
Chronic Pain, tenderpoints, insomnia, mood disorder, fatigue

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on August 28, 2014