Fibromyalgia Treatment Trial With Gabapentin and Osteopathic Manipulative Medicine

Fibromyalgia Clinical Trial

— FTTGO  

Official title:

Phase III Study of the Use of Gabapentin and Osteopathic Manipulative Medicine to Treat Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107574
• Other study ID #: 04-01-2004
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2010
• Last updated: August 27, 2013
• Start date: April 2004
• Est. completion date: April 2010

Study information

• Verified date: August 2013
• Source: Good Samaritan Regional Medical Center, Oregon
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
United States	Touro University College of Osteoapathic Medicine	Vallejo	California

Sponsors (2)

Lead Sponsor	Collaborator
Good Samaritan Regional Medical Center, Oregon	Touro University,Vallejo,California

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hansen HC. Treatment of chronic pain with antiepileptic drugs: a new era. South Med J. 1999 Jul;92(7):642-9. Review. — View Citation

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

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

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

Nöller V, Sprott H. Prospective epidemiological observations on the course of the disease in fibromyalgia patients. J Negat Results Biomed. 2003 Aug 23;2:4. — View Citation

Rivera J, González 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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	safety of Osteopathic Manipulative Medicine and Gapapentin by evaluation of treatment reactions weekly and laboratories before and after the study.	8 weeks	Yes

External Links

•   Department of Research