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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00222690
Other study ID # 0505178
Secondary ID
Status Completed
Phase N/A
First received September 14, 2005
Last updated May 26, 2006
Start date June 2005
Est. completion date June 2006

Study information

Verified date September 2005
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The purpose of this study is to conduct semi-structured qualitative interviews to examine the personal experiences of women living with fibromyalgia. The specific aims of this study are to identify clinically relevant “triggers” of fibromyalgia symptoms and examine their impact on activity limitations and participation restrictions.


Description:

Fibromyalgia (FM) may currently be the most common rheumatic diagnosis of rheumatologists among their female patients, with 15-20% of all new rheumatology referrals meeting the 1990 American College of Rheumatology (ACR) diagnosis criteria for fibromyalgia. People with fibromyalgia live through widespread musculoskeletal chronic pain, fatigue, psychological distress, and exhibit diminished physical performance due in part to the cycle of pain that adversely affect their activity participation and overall well-being.

The purpose of this prospective mixed methods study is to conduct semi-structured qualitative interviews using ethnographic techniques to examine the personal experiences of women living with fibromyalgia. The specific aims of this study are to identify clinically relevant “triggers” of fibromyalgia symptoms and examine their impact on activity limitations and participation restrictions.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

(1)At least 18 years of age; (2) meet the American College of Rheumatology (ACR) criteria for FM as diagnosed by a physician; (3) have been diagnosed with FM at least 1 year prior to admission to the study; (4) have sufficient vision, based on a functional vision test (i.e., read newsprint) to operate a computer program; (5) speak English; and (6) have a private telephone line.

Exclusion Criteria:

(1)Living beyond a 40-mile radius from the Oakland campus of the University of Pittsburgh. (2)Disability in everyday tasks related to a diagnosis other than FM (e.g., stroke, Parkinson disease) will also be grounds for exclusion.

Study Design

Allocation: Random Sample, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Pittsburgh - Department of Occupational Therapy Pittsburgh Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
University of Pittsburgh SHRS Research Development Fund, U.S. Department of Education

Country where clinical trial is conducted

United States, 

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