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Clinical Trials/NCT00334620
NCT00334620CompletedPhase 4

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

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster1 site in 1 country140 target enrollmentStarted: July 1, 1998Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
140
Locations
1
Primary Endpoint
limitations in everyday life and private activities

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Untitled Study

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

Outcomes

Primary Outcomes

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 Outcomes

  • pain intensity
  • pain frequency
  • morning stiffness
  • functional capacity
  • drug consumption (steroids; NSAIDs; DMARDs only descriptively)

Investigators

Sponsor
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Sponsor Class
Other Gov

Study Sites (1)

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