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

Sponsor:	Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Information provided by:	Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
ClinicalTrials.gov Identifier:	NCT00324441

Purpose

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.

Condition	Intervention	Phase
Fibromyalgia	Device: Iratherm® 1000	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Fever Fibromyalgia Rehabilitation

U.S. FDA Resources

Further study details as provided by Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	132
Study Start Date:	January 2004
Estimated Study Completion Date:	July 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324441

Locations

Germany
Rehabilitationsklinik Hoher Meissner
Bad Sooden-Allendorf, Hessen, Germany, 37242

Sponsors and Collaborators

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

Investigators

Study Chair:

Thomas Brockow, MD

FBK Bad Elster

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00324441 History of Changes
Other Study ID Numbers:	WBH-FM-1
Study First Received:	May 9, 2006
Last Updated:	May 9, 2006
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster:

Fibromyalgia
Rehabilitation
Physical Medicine
Whole-Body Hyperthermia
Water-Filtered Near Infrared

Additional relevant MeSH terms:

Fever
Fibromyalgia
Myofascial Pain Syndromes
Body Temperature Changes
Signs and Symptoms

Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 12, 2012