Fibromyalgia Treatment Trial With Gabapentin and Osteopathic Manipulative Medicine

NCT01107574 | Completed Phase 3 DMC

• 1 other identifier: 04-01-2004
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Chronic Pain, tenderpoints, insomnia, mood disorder, fatigue

Outcome Measures

Primary Outcomes (1)

• Outcomes of Efficacy and Tolerability by measure of scored visual tools

  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.

  8 Weeks

Secondary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  8 weeks

Study Arms (3)

Gabapentin and Osteopathic Manipulative Medicine

EXPERIMENTAL

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

Gabapentin

EXPERIMENTAL

Gabapentin was given orally at 900 mg at HS weekly for 6 weeks.

Drug: Gabapentin

Osteopathic Manipulative Medicine

EXPERIMENTAL

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

Interventions

Gabapentin DRUG

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

Also known as: Neurontin

Gabapentin

Osteopathic Manipulative Medicine PROCEDURE

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.

Also known as: Osteopathic Manipulation Treatment

Osteopathic Manipulative Medicine

Gabapentin and Osteopathic Manipulative Medicine OTHER

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

Also known as: Combined OMM and Neurontin

Gabapentin and Osteopathic Manipulative Medicine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male patients were eligible for the study if they were 18-65 years of age and met the ACR criteria for fibromyalgia (\[1\]).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Good Samaritan Regional Medical Center, Oregon: lead
• Touro University,Vallejo,California: collaborator

Study Sites (1)

Touro University College of Osteoapathic Medicine

Vallejo, California, 94592, United States

Location

Related Publications (13)

• Antai-Otong D. The art of prescribing. Depression and fibromyalgia syndrome (FMS): pharmacologic considerations. Perspect Psychiatr Care. 2005 Jul-Sep;41(3):146-8. doi: 10.1111/j.1744-6163.2005.00028.x. No abstract available.

  PMID: 16138826 BACKGROUND

• Arnold LM, Goldenberg DL, Stanford SB, Lalonde JK, Sandhu HS, Keck PE Jr, Welge JA, Bishop F, Stanford KE, Hess EV, Hudson JI. Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum. 2007 Apr;56(4):1336-44. doi: 10.1002/art.22457.

  PMID: 17393438 BACKGROUND

• Bennett RM. Emerging concepts in the neurobiology of chronic pain: evidence of abnormal sensory processing in fibromyalgia. Mayo Clin Proc. 1999 Apr;74(4):385-98. doi: 10.4065/74.4.385.

  PMID: 10221469 BACKGROUND

• Blunt KL, Rajwani MH, Guerriero RC. The effectiveness of chiropractic management of fibromyalgia patients: a pilot study. J Manipulative Physiol Ther. 1997 Jul-Aug;20(6):389-99.

  PMID: 9272472 BACKGROUND

• Gamber RG, Shores JH, Russo DP, Jimenez C, Rubin BR. Osteopathic manipulative treatment in conjunction with medication relieves pain associated with fibromyalgia syndrome: results of a randomized clinical pilot project. J Am Osteopath Assoc. 2002 Jun;102(6):321-5.

  PMID: 12090649 BACKGROUND

• Hains G, Hains F. A combined ischemic compression and spinal manipulation in the treatment of fibromyalgia: a preliminary estimate of dose and efficacy. J Manipulative Physiol Ther. 2000 May;23(4):225-30.

  PMID: 10820294 BACKGROUND

• Johnson SM, Kurtz ME. Osteopathic manipulative treatment techniques preferred by contemporary osteopathic physicians. J Am Osteopath Assoc. 2003 May;103(5):219-24.

  PMID: 12776762 BACKGROUND

• Maizels M, McCarberg B. Antidepressants and antiepileptic drugs for chronic non-cancer pain. Am Fam Physician. 2005 Feb 1;71(3):483-90.

  PMID: 15712623 BACKGROUND

• McCleane G. Gabapentin reduces chronic benign nociceptive pain: a double-blind, placebo-controlled cross-over study. The Pain Clinic. 2000; 12(2):81-85.

  BACKGROUND

• Noller V, Sprott H. Prospective epidemiological observations on the course of the disease in fibromyalgia patients. J Negat Results Biomed. 2003 Aug 23;2:4. doi: 10.1186/1477-5751-2-4.

  PMID: 12969513 BACKGROUND

• Rivera J, Gonzalez T. The Fibromyalgia Impact Questionnaire: a validated Spanish version to assess the health status in women with fibromyalgia. Clin Exp Rheumatol. 2004 Sep-Oct;22(5):554-60.

  PMID: 15485007 BACKGROUND

• Hansen HC. Treatment of chronic pain with antiepileptic drugs: a new era. South Med J. 1999 Jul;92(7):642-9. doi: 10.1097/00007611-199907000-00001.

  PMID: 10414471 BACKGROUND

• Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.

  PMID: 2306288 BACKGROUND

Related Links

• Department of Research

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Sleep Initiation and Maintenance Disorders; Mood Disorders; Fatigue

Interventions

Gabapentin; Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Alejandro Gugliucci, MD, PhD

  Touro University-CA, Vallejo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director Internal Medicine Residency

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 21, 2010
• Study Start: April 1, 2004
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2010
• Last Updated: August 28, 2013

Record last verified: 2013-08

Locations

US (1)