Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324441
Status:
COMPLETED
Last Update Posted:
2006-05-11
First Post:
2006-05-09
Brief Title:
Mild Water-Filtered Near Infrared Whole-Body-Hyperthermia as an Adjunct in the Treatment of Fibromyalgia
Sponsor:
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Organization:
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Study Overview
Official Title:
A Randomized Controlled Trial on the Effectiveness of Mild Water-Filtered Near Infrared Hyperthermia as an Adjunct to a Standard Multimodal Rehabilitation in the Treatment of Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2003-08
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 purpose of the study is to evaluate whether mild walter-filtered near infrared hyperthermia produces an additional benefit when applied as an adjunct to standard multimodal rehabilitation compared to standard multimodal rehabilitation only in patients with fibromyalgia
Detailed Description:
Mild systemic heat agents including infrared whole-body hyperthermia are used as treatment options in multimodal rehabilitation programs for fibromyalgia in Germany However no randomized controlled clinical trial exists on their effectiveness for this condition
This study is designed as an add-on study to evaluate the additional benefit of mild walter-filtered near infrared hyperthermia and a standard multimodal rehabilitation program compared to a standard multimodal rehabilitation program only Standard multimodal rehabilitation is configured as usually applied in clinical trials with exercise cognitive behavioral therapy and health education as the main treatment components
Mild walter-filtered near infrared hyperthermia heating-up to 381 degrees C body core temperature followed by a 15-min heat retention period is administered twice a week over 3 weeks during a rehabilitation hospital stay
Primary outcome measures are measured at baseline postintervention 3 and 6 months postintervention Analysis is done by intention to treat for significance testing Repeated Measures ANCOVA is used
This study is designed as an add-on study to evaluate the additional benefit of mild walter-filtered near infrared hyperthermia and a standard multimodal rehabilitation program compared to a standard multimodal rehabilitation program only Standard multimodal rehabilitation is configured as usually applied in clinical trials with exercise cognitive behavioral therapy and health education as the main treatment components
Mild walter-filtered near infrared hyperthermia heating-up to 381 degrees C body core temperature followed by a 15-min heat retention period is administered twice a week over 3 weeks during a rehabilitation hospital stay
Primary outcome measures are measured at baseline postintervention 3 and 6 months postintervention Analysis is done by intention to treat for significance testing Repeated Measures ANCOVA is used
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