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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00324441
First Posted: May 11, 2006
Last Update Posted: May 11, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00324441     History of Changes
Other Study ID Numbers: WBH-FM-1
First Submitted: May 9, 2006
First Posted: May 11, 2006
Last Update Posted: May 11, 2006
Last Verified: August 2003

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:
Fibromyalgia
Myofascial Pain Syndromes
Fever
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Body Temperature Changes
Signs and Symptoms