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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Procedure: 15 radon(+CO2) baths vs 15 CO2 baths; beside rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rheumatoid arthritis according to the 1987 revised ACR criteria for RA 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 15 radon(+CO2) baths vs 15 CO2 baths; beside rehabilitation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| limitations in everyday life and private activities |  |  | 
| limitations in the occupational context (not for pensioners) |  |  | 
| (both self-assessed on 2 100mm-VAS, averaged into 1 criterion if applicable) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity |  |  | 
| pain frequency |  |  | 
| morning stiffness |  |  | 
| functional capacity |  |  | 
| drug consumption (steroids; NSAIDs; DMARDs only descriptively) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomised double-blinded trial, rehabilitation, radon spa therapy, long-term effectiveness