Full Text View
Tabular View
No Study Results Posted
Related Studies
Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention
This study has been completed.
Study NCT00010777   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: February 2, 2001   Last Updated: August 17, 2006   History of Changes

February 2, 2001
August 17, 2006
September 1999
 
 
 
Complete list of historical versions of study NCT00010777 on ClinicalTrials.gov Archive Site
 
 
 
Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention
Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention

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.

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.

Phase II
Interventional
Treatment, Randomized
Fibromyalgia
Procedure: Multiple Component Mind/Body therapy
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
March 2004
 

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00010777
 
P50 AT000084-01P2, P50 AT000084-01
National Center for Complementary and Alternative Medicine (NCCAM)
 
Principal Investigator: Dr. Brian Berman Univ. of Maryland/Complementary Medicine Program
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP