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Completed

NCT Number: NCT00324441

Mild Water-Filtered Near Infrared Whole-Body-Hyperthermia as an Adjunct 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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rehabilitationsklinik Hoher Meissner

Bad Sooden-Allendorf, Hesse, 37242, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iratherm® 1000

Device

Primary outcomes

  1. affective pain (German version of the McGill Pain Questionnaire)

  2. sensory pain (German version of the McGill Pain Questionnaire)

Secondary outcomes

  1. pain intensity (visual analogue scale)

  2. Fibromyalgia related quality of life(German version of the Fibromyalgia Impact Questionnaire)

  3. tender point assessment(mean tender point pain threshold, total tender point intensity, tender point count)

  4. adverse events, side effects

Sponsors and collaborators

Lead sponsor

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

Other Gov

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2005
First posted
May 11, 2006
Registry last updated
May 11, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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