Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000398
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
1999-11-03
Brief Title:
Behavioral Treatment of Fibromyalgia
Sponsor:
Ohio University
Organization:
Ohio University
Study Overview
Official Title:
Behavioral Treatment of Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2000-06
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:
Fibromyalgia FM is one of the most common rheumatic diseases conditions or disorders that cause pain or stiffness in the joints muscles or bones It affects 6 million Americans and up to 20 percent of patients seen by doctors who specialize in treating rheumatic diseases This study will evaluate the effects of two of the most promising nondrug treatments for FM coping skills training and physical exercise training We will randomly assign each of 180 patients diagnosed with FM to one of four groups coping skills training CST physical exercise training alone CST plus physical exercise training or a waiting list nontreatment group We will look at the separate and combined effects of CST and physical exercise training and evaluate how changes in aerobic fitness self-effectiveness a persons belief in his or her ability to reach a goal such as managing ones own disease and negative pain-related thoughts relate to improvements in pain and disability
Detailed Description:
Fibromyalgia FM is characterized by diffuse musculoskeletal pain discrete tender points at typical soft-tissue sites fatigue stiffness and sleep problems Of these symptoms pain is often the primary concern of FM patients and their physicians Traditional medical approaches to managing FM have limitations side effects and have not been effective in managing pain Given these limitations treatments that involve nonpharmacologic interventions may represent a valuable addition to patient care This study will evaluate the effects of two of the most promising nonpharmacologic interventions for FM coping skills training CST for pain management and physical exercise training
The study is designed to test the hypothesis that an intervention that combines CST and physical exercise training will be more effective than CST or exercise alone In this study we will randomly assign each of 180 patients diagnosed with FM to one of four conditions CST alone physical exercise training alone CST plus physical exercise training or a waiting list control We will evaluate study participants on four occasions pre-treatment post-treatment 3-month followup and 6-month followup
The study will look at the separate and combined effects of CST and physical exercise training and evaluate how changes in aerobic fitness self-effectiveness and negative pain-related thoughts relate to improvements in pain and disability Physicians could use this information in matching FM patients to treatment interventions In addition our findings may have implications for treatment selection for a broad range of patients suffering from persistent pain
The study is designed to test the hypothesis that an intervention that combines CST and physical exercise training will be more effective than CST or exercise alone In this study we will randomly assign each of 180 patients diagnosed with FM to one of four conditions CST alone physical exercise training alone CST plus physical exercise training or a waiting list control We will evaluate study participants on four occasions pre-treatment post-treatment 3-month followup and 6-month followup
The study will look at the separate and combined effects of CST and physical exercise training and evaluate how changes in aerobic fitness self-effectiveness and negative pain-related thoughts relate to improvements in pain and disability Physicians could use this information in matching FM patients to treatment interventions In addition our findings may have implications for treatment selection for a broad range of patients suffering from persistent pain
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-032 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR044064 |
| R01AR044064 | NIH | None | None |