Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088777
Status:
COMPLETED
Last Update Posted:
2011-08-12
First Post:
2004-08-04
Brief Title:
Nondrug Treatment Programs for Adults With Fibromyalgia
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Behavioral Preparation for Treating Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2011-08
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 syndrome is a common chronic pain disorder that may benefit from nondrug treatment This study will compare the effectiveness of behavioral preparation stress management education and fibromyalgia and coping education in relieving the symptoms of FM Each of these nondrug treatments will be combined with physical therapy and physical education
Specific aims 1 Evaluate the efficacy of behavioral preparation programs on attrition compliance and treatment outcomes of self-management rehabilitation for FM syndrome 2 Determine factors that mediate clinical efficacy 3 Evaluate individual differences in treatment responses to delineate who will benefit most from each type of the behavioral preparation programs
Specific aims 1 Evaluate the efficacy of behavioral preparation programs on attrition compliance and treatment outcomes of self-management rehabilitation for FM syndrome 2 Determine factors that mediate clinical efficacy 3 Evaluate individual differences in treatment responses to delineate who will benefit most from each type of the behavioral preparation programs
Detailed Description:
FM is a chronic pain condition causing discomfort and disability there is no known cure Research suggests that combination treatment of physical therapy fibromyalgia education and stress management education is helpful for many patients with this condition However how much benefit patients get from such therapies varies greatly This study will evaluate the effectiveness of behavioral preparation stress management education and fibromyalgia and coping education each in combination with physical therapy and physical education in relieving the symptoms of FM
The study will last approximately 15 months Participants will undergo a comprehensive assessment including medical physical and psychological evaluations Blood will be collected to measure participants serotonin levels participants will also be asked to complete several questionnaires to assess their FM symptoms and joint function For a 7-day period prior to starting behavioral interventions participants will be asked to carry a personal-size digit assistant PDA that will ask them questions about their quality of life three times a day During this time they will also continuously wear a wristwatch-like device to measure functional movement and quality of sleep
For 10 weeks participants will undergo therapy sessions of one of the behavioral interventions behavioral preparation stress management education or fibromyalgia and coping education along with physical therapy and physical education During Weeks 1 through 4 participants will receive 2 hours of their assigned intervention During Weeks 5 and 6 they will receive 1 hour of their assigned intervention and 1 hour of physical therapy During Weeks 7 through 9 they will receive 1 hour of physical therapy and 1 hour of physical education During Week 10 they will receive 1 hour of their assigned intervention and 1 hour of physical therapy
The study will last approximately 15 months Participants will undergo a comprehensive assessment including medical physical and psychological evaluations Blood will be collected to measure participants serotonin levels participants will also be asked to complete several questionnaires to assess their FM symptoms and joint function For a 7-day period prior to starting behavioral interventions participants will be asked to carry a personal-size digit assistant PDA that will ask them questions about their quality of life three times a day During this time they will also continuously wear a wristwatch-like device to measure functional movement and quality of sleep
For 10 weeks participants will undergo therapy sessions of one of the behavioral interventions behavioral preparation stress management education or fibromyalgia and coping education along with physical therapy and physical education During Weeks 1 through 4 participants will receive 2 hours of their assigned intervention During Weeks 5 and 6 they will receive 1 hour of their assigned intervention and 1 hour of physical therapy During Weeks 7 through 9 they will receive 1 hour of physical therapy and 1 hour of physical education During Week 10 they will receive 1 hour of their assigned intervention and 1 hour of physical therapy
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 |
|---|---|---|---|
| 5R01AR048888-06 | NIH | None | None |
| R01AR048888-01A2 | NIH | None | httpsreporternihgovquickSearchR01AR048888-01A2 |