Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010777
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2001-02-02
Brief Title:
Fibromyalgia A Randomized Controlled Trial of a MindBody Intervention
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Fibromyalgia A Randomized Controlled Trial of a MindBody Intervention
Status:
COMPLETED
Status Verified Date:
2006-08
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:
The goal of this proposal is to evaluate the efficacy of a multiple component mind-body MCMB therapy for fibromyalgia both in short and long term outcomes Preliminary work suggests that FM patients do benefit from MCMB therapy Singh et al 1998 Creamer et al 1998 This two-arm clinical trial will randomize 110 patients to either a 12 week MCMB intervention or a 12 week educationattention intervention The primary aims of this study are 1 to determine if a 12 week MCMB intervention improves short term ie at 12 weeks outcomes in FM patients compared to an educationattention control group and 2 to determine if a 12 week MCMB intervention improves long term ie at 24 weeks outcomes in FM patients compared to an educationattention control group
A secondary aim of this project involves determining if there are patient characteristics ie disease severity and duration demographics psychological factors associated with improvements in short or long term outcomes as well as responses to the MCMB intervention
The primary outcome measure will include physical functioning and pain as measured by the Fibromyalgia Impact Questionnaire
A secondary aim of this project involves determining if there are patient characteristics ie disease severity and duration demographics psychological factors associated with improvements in short or long term outcomes as well as responses to the MCMB intervention
The primary outcome measure will include physical functioning and pain as measured by the Fibromyalgia Impact Questionnaire
Detailed Description:
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 34 in females and 05 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 evaluate the efficacy of a multiple component mind-body MCMBtherapy for fibromyalgia both in short and long term outcomes Preliminary work suggests that FM patients do benefit from MCMB therapy Singh et al 1998 Creamer et al 1998 This two-arm clinical trial will randomize 110 patients to either a 12 week MCMB intervention or a 12 week educationattention intervention The primary aims of this study are 1 to determine if a 12 week MCMB intervention improves short term ie at 12 weeks outcomes in FM patients compared to an educationattention control group and 2 to determine if a 12 week MCMB intervention improves long term ie at 24 weeks outcomes in FM patients compared to an educationattention control group
A secondary aim of this project involves determining if there are patient characteristics ie disease severity and duration demographics psychological factors associated with improvements in short or long term outcomes as well as responses to the MCMB intervention
The primary outcome measure will include physical functioning and pain as measured by the Fibromyalgia Impact Questionnaire
The goal of this proposal is to evaluate the efficacy of a multiple component mind-body MCMBtherapy for fibromyalgia both in short and long term outcomes Preliminary work suggests that FM patients do benefit from MCMB therapy Singh et al 1998 Creamer et al 1998 This two-arm clinical trial will randomize 110 patients to either a 12 week MCMB intervention or a 12 week educationattention intervention The primary aims of this study are 1 to determine if a 12 week MCMB intervention improves short term ie at 12 weeks outcomes in FM patients compared to an educationattention control group and 2 to determine if a 12 week MCMB intervention improves long term ie at 24 weeks outcomes in FM patients compared to an educationattention control group
A secondary aim of this project involves determining if there are patient characteristics ie disease severity and duration demographics psychological factors associated with improvements in short or long term outcomes as well as responses to the MCMB intervention
The primary outcome measure will include physical functioning and pain as measured by the Fibromyalgia Impact Questionnaire
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 |
|---|---|---|---|
| P50AT000084-01 | NIH | None | httpsreporternihgovquickSearchP50AT000084-01 |