Effectiveness of Radon Spa Therapy in Multimodal Rehabilitative Treatment of Rheumatoid Arthritis

Last updated: June 7, 2006
Sponsor: Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Overall Status: Completed

Phase

4

Condition

Bone Diseases

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT00334620
BB-3I_1998
  • Ages > 18
  • All Genders

Study Summary

The study aimed to investigate effects of radon (plus CO2) baths on RA in contrast to artificial CO2 baths in RA rehabilitation.

134 patients of an in-patient rehabilitative programme were randomly assigned to the groups. Outcomes were limitations in occupational context/ daily living (main outcome), pain, medication, etc. measured before start, after end of treatment, and up to a year thereafter.

Superiority of radon treatment was found regarding reduced limitations in daily living until 12 months after end of treatment. Steroid consumption and NSAIDs were significantly reduced.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Rheumatoid arthritis according to the 1987 revised ACR criteria for RA

Exclusion

Exclusion Criteria:

  • current exacerbations of the inflammatory process

  • other systemic inflammatory diseases

  • concomitant musculo-skeletal diseases possibly interfering with outcome measurement,

  • pregnancy or breast feeding

  • disorders of the central nervous system

  • a known tendency toward thrombosis

  • malignant hypertension

  • coronary heart disease

  • heart failure, arrhythmia

  • severe disorders of lungs, kidneys, or liver

  • advanced malignancies

  • abuse of alcohol or drugs,

  • major skin lesions,

  • severe fever, or infections.

Study Design

Total Participants: 140
Study Start date:
July 01, 1998
Estimated Completion Date:
May 31, 2005

Study Description

Objective: To replicate former observed beneficial effects of Radon (plus CO2) baths on RA in contrast to artificial CO2 baths and to investigate its long-term effectiveness and impact on drug consumption.

Methods: Randomised double-blinded trial with 2 randomised balanced groups enrolling 134 patients of an in-patient rehabilitative programme (a 3rd non-randomised group of 73 consecutive patients is not reported here). Outcomes were limitations in occupational context/ daily living, pain, functional capacity, morning stiffness and medication measured before start, after end of treatment, and quarterly in the year thereafter. Repeated-measures analysis of covariance (RM-ANCOVA) of intent-to treat population was performed to investigate treatment effects. Hierarchically ordered hypotheses ensured adherence of the nominal significance level and allowed examining of long-term effects. Starting with all measures until 6 months’ follow-up, significant main effects for group allocation (GME) or significant group x course-interactions (GxC) were regarded essential to add the next follow-up for analysis.

Results: Radon treatment resulted in significantly lower limitations of daily living over at least 9 months whereas reference patients returned to baseline level after 6 months already (RM-ANCOVA until 6 months: pGME=.15, pGxC=.016/ 9 months: pGME=.11, pGxC=.025/ 12 months: pGME=.17, pGxC=.033). Furthermore, consumption of steroids and NSAID was remarkably reduced in the Radon group (RM-ANCOVA until 12 months: for steroids pGME=.064, interaction pGxC=.025, maximum difference after 12 months; for NSAID pGME=.035, interaction pGxC=.008, maximum difference after 9 months).

Conclusion: Results suggest beneficial long-term effects of Radon baths as adjunct to a multimodal rehabilitative treatment of RA.

Connect with a study center

  • Klinik Bad Brambach

    Bad Brambach, Saxony D-08648
    Germany

    Site Not Available

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