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Search / Trial NCT00010777

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

Launched by NATIONAL CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH (NCCIH) · Feb 2, 2001

Trial Information

Current as of July 22, 2025

Completed

Keywords

ClinConnect Summary

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 eva...

Gender

ALL

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.

About National Center For Complementary And Integrative Health (Nccih)

The National Center for Complementary and Integrative Health (NCCIH) is a prominent U.S. government agency dedicated to advancing the understanding and integration of complementary and alternative medicine into conventional healthcare. As a part of the National Institutes of Health (NIH), NCCIH supports rigorous scientific research to evaluate the efficacy, safety, and mechanisms of complementary approaches, promoting evidence-based practices in health and wellness. By fostering collaboration among researchers, healthcare providers, and the public, NCCIH aims to enhance health outcomes and empower individuals to make informed decisions about their health and well-being.

Locations

Patients applied

0 patients applied

Trial Officials

Dr. Brian Berman

Principal Investigator

Univ. of Maryland/Complementary Medicine Program

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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