Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention

NCT ID: NCT00010777

Last Updated: 2006-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-30
• Study Completion Date: 2004-03-31

Brief Summary

The goal of this proposal is to evaluate the efficacy of a multiple component mind-body (MCMB) therapy for fibromyalgia, both in short and long term outcomes. Preliminary work suggests that FM patients do benefit from MCMB therapy (Singh et al 1998; Creamer et al 1998). This two-arm clinical trial will randomize 110 patients to either a 12 week MCMB intervention or a 12 week education/attention intervention. The primary aims of this study are 1) to determine if a 12 week MCMB intervention improves short term (i.e. at 12 weeks) outcomes in FM patients compared to an education/attention control group; and 2) to determine if a 12 week MCMB intervention improves long term (i.e. at 24 weeks) outcomes in FM patients compared to an education/attention control group.

A secondary aim of this project involves determining if there are patient characteristics (i.e. disease severity and duration, demographics, psychological factors) associated with improvements in short or long term outcomes as well as responses to the MCMB intervention.

The primary outcome measure will include physical functioning and pain as measured by the Fibromyalgia Impact Questionnaire.

Detailed Description

Fibromyalgia (FM) is a common, complex and chronic condition of unknown etiology (Carette 1994). It is characterized by widespread musculoskeletal pain, multiple tender points, fatigue and a range of other symptoms (Wolfe 1990). FM accounts for 15% of rheumatology consultations, with a prevalence of 2% in the general population (3.4% in females and 0.5% in males), rising to 7% in the elderly females (Wolfe 1995). Disability levels in social and work roles, as well as use of medical care, is high. Current treatment options often meet with limited success.

The goal of this proposal is to evaluate the efficacy of a multiple component mind-body (MCMB)therapy for fibromyalgia, both in short and long term outcomes. Preliminary work suggests that FM patients do benefit from MCMB therapy (Singh et al 1998; Creamer et al 1998). This two-arm clinical trial will randomize 110 patients to either a 12 week MCMB intervention or a 12 week education/attention intervention. The primary aims of this study are (1) to determine if a 12 week MCMB intervention improves short term (i.e. at 12 weeks) outcomes in FM patients compared to an education/attention control group; and (2) to determine if a 12 week MCMB intervention improves long term (i.e. at 24 weeks) outcomes in FM patients compared to an education/attention control group.

A secondary aim of this project involves determining if there are patient characteristics (i.e. disease severity and duration, demographics, psychological factors) associated with improvements in short or long term outcomes as well as responses to the MCMB intervention.

The primary outcome measure will include physical functioning and pain as measured by the Fibromyalgia Impact Questionnaire.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

Multiple Component Mind/Body therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of fibromyalgia by patient's own health care provider
• ACT classification of fibromyalgia verified by rheumatological examination: a) widespread pain (axial plus upper and lower segment plus left-and-right-sided pain for 3 months or longer; b) tenderness at 11 or more of the 18 specific tender point sites
• Read and speak English fluently
• Be able to attend group intervention session if assigned to that group
• Able to give informed consent

Exclusion Criteria

• Pregnancy
• Substance abuse
• Major psychiatric disorder (that would prevent compliance)
• Involvement in impending litigation or judgment for disability workmen's compensation
• Uncontrolled hypertension, uncontrolled diabetes, congestive heart failure or other severe chronic medical conditions judged by the clinician to place the patient at risk of possible severe consequences of their disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: lead

Principal Investigators

Dr. Brian Berman

Role: PRINCIPAL_INVESTIGATOR

Univ. of Maryland/Complementary Medicine Program

References

Astin JA, Berman BM, Bausell B, Lee WL, Hochberg M, Forys KL. The efficacy of mindfulness meditation plus Qigong movement therapy in the treatment of fibromyalgia: a randomized controlled trial. J Rheumatol. 2003 Oct;30(10):2257-62.

Reference Type: BACKGROUND

PMID: 14528526 (View on PubMed)

Other Identifiers

P50AT000084-01

Identifier Type: NIH

Identifier Source: secondary_id

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P50AT000084-01P2

Identifier Type: NIH

Identifier Source: org_study_id

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NCT00009152

Identifier Type: -

Identifier Source: nct_alias