Mild Water-Filtered Near Infrared Whole-Body-Hyperthermia as an Adjunct in the Treatment of Fibromyalgia - Tabular View

Tracking Information

First Received Date ^ICMJE

May 9, 2006

Last Updated Date

May 9, 2006

Start Date ^ICMJE

January 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

affective pain (German version of the McGill Pain Questionnaire)
sensory pain (German version of the McGill Pain Questionnaire)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

pain intensity (visual analogue scale)
Fibromyalgia related quality of life(German version of the Fibromyalgia Impact Questionnaire)
tender point assessment(mean tender point pain threshold, total tender point intensity, tender point count)
adverse events, side effects

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Mild Water-Filtered Near Infrared Whole-Body-Hyperthermia as an Adjunct in the Treatment of Fibromyalgia

Official Title ^ICMJE

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

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 38.1 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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Fibromyalgia

Intervention ^ICMJE

Device: Iratherm® 1000

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

132

Completion Date

July 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

participants must meet the American College of Rheumatology 1990 criteria for fibromyalgia
participants must report a score ≥ 4 on the pain intensity subscale of the Fibromyalgia Impact Questionnaire (range: 0-10)
participants must report a score ≥ 4 on the normalized physical functioning subscale of the Fibromyalgia Impact Questionnaire (range: 0-10)
participants must be aged between 18 and 70 years

Exclusion Criteria:

severe cardiovascular disease
metabolic disease
nervous system disorder
blood coagulation disease
cancer
acute inflammatory disease
status after organ transplantation
reduced general health (Karnofsky Index ≤ 50)
pregnant women
breast feeding women
persons involved in a pending litigation for early pensioning due to fibromyalgia
persons planning to apply for a pension due to fibromyalgia

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00324441

Responsible Party

Study ID Numbers ^ICMJE

WBH-FM-1

Study Sponsor ^ICMJE

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Thomas Brockow, MD

FBK Bad Elster

Information Provided By

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

Verification Date

August 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP