NCT00324441

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
Last Updated

May 11, 2006

Status Verified

August 1, 2003

First QC Date

May 9, 2006

Last Update Submit

May 9, 2006

Conditions

Fibromyalgia

Keywords

FibromyalgiaRehabilitationPhysical MedicineWhole-Body HyperthermiaWater-Filtered Near Infrared

Outcome Measures

Primary Outcomes (2)

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

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

Secondary Outcomes (4)

  • 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

Interventions

Iratherm® 1000DEVICE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitationsklinik Hoher Meissner

Bad Sooden-Allendorf, Hesse, 37242, Germany

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Thomas Brockow, MD

    FBK Bad Elster

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 9, 2006

First Posted

May 11, 2006

Study Start

January 1, 2004

Study Completion

July 1, 2005

Last Updated

May 11, 2006

Record last verified: 2003-08

Locations

DE(1)