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

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324441
• Other study ID #: WBH-FM-1
• Status: Completed
• Phase: Phase 2
• First received: May 9, 2006
• Last updated: May 9, 2006
• Start date: January 2004
• Est. completion date: July 2005

Study information

• Verified date: August 2003
• Source: Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Fever
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• Iratherm® 1000

Locations

Country	Name	City	State
Germany	Rehabilitationsklinik Hoher Meissner	Bad Sooden-Allendorf	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	affective pain (German version of the McGill Pain Questionnaire)
Primary	sensory pain (German version of the McGill Pain Questionnaire)
Secondary	pain intensity (visual analogue scale)
Secondary	Fibromyalgia related quality of life(German version of the Fibromyalgia Impact Questionnaire)
Secondary	tender point assessment(mean tender point pain threshold, total tender point intensity, tender point count)
Secondary	adverse events, side effects