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

May 9, 2006 updated by: Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

Investigators

  • Study Chair: Thomas Brockow, MD, FBK Bad Elster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

May 9, 2006

First Submitted That Met QC Criteria

May 9, 2006

First Posted (ESTIMATE)

May 11, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 11, 2006

Last Update Submitted That Met QC Criteria

May 9, 2006

Last Verified

August 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WBH-FM-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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