Viewing Study NCT00000423



Ignite Creation Date: 2024-05-05 @ 11:20 AM
Last Modification Date: 2024-10-26 @ 9:01 AM
Study NCT ID: NCT00000423
Status: COMPLETED
Last Update Posted: 2013-12-04
First Post: 1999-11-03

Brief Title: Support Health and Fibromyalgia
Sponsor: San Diego State University
Organization: San Diego State University

Study Overview

Official Title: Social Support and Health in Fibromyalgia
Status: COMPLETED
Status Verified Date: 2001-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study tests the effects of social support and education on the health and well-being of people with fibromyalgia FMS We recruited 600 adults with a confirmed diagnosis of FMS from a large health maintenance organization We randomly assigned the study participants to one of three groups People in the social support group met with others who suffer from FMS for 2 hours every week for 10 weeks and then monthly for an additional 10 months The social support and education group also had 10 2-hour weekly meetings followed by 10 monthly meetings with others who suffer from FMS Members of this group learned about the disease and ways they can manage it themselves The third group participated only in the five assessment periods The study lasted 4 years
Detailed Description: Next to osteoarthritis FMS is the most common arthritis-related disease Symptoms include musculoskeletal pain fatigue headaches irritable bowel syndrome morning stiffness and sleep disturbances Fluctuating severity pain and frustration with the difficulty of diagnosis and treatment lead patients to continually seek help from health care professionals There is no known cause or cure for this disease

This study tests the effects of social support and education on the health and well-being of people with fibromyalgia FMS We recruited 600 adults with a confirmed diagnosis of FMS from a large health maintenance organization To be eligible people had to meet the American College of Rheumatology guidelines for FMS After we confirmed the diagnosis we assigned those who agreed to participate to one of three groups The first group social support met with others who suffer from FMS for 2 hours every week for 10 weeks and then monthly for an additional 10 months The second group social support and education also had 10 2-hour weekly meetings followed by 10 monthly meetings with others who suffer from FMS and its members learned about the disease and self-management techniques The third group control participated only in the five assessment periods We assessed people in all three groups before we assigned them to a group after the intervention and at yearly follow-ups The study duration was 4 years

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
NIAMS-029 US NIH GrantContract None httpsreporternihgovquickSearchR01AR044020
R01AR044020 NIH None None