Effectiveness of Radon Spa Therapy in Multimodal Rehabilitative Treatment of Rheumatoid Arthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00334620|
Recruitment Status : Completed
First Posted : June 8, 2006
Last Update Posted : June 8, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Procedure: 15 radon(+CO2) baths vs 15 CO2 baths; beside rehabilitation||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||July 1998|
|Estimated Study Completion Date :||May 2005|
- 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)
- pain intensity
- pain frequency
- morning stiffness
- functional capacity
- drug consumption (steroids; NSAIDs; DMARDs only descriptively)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334620
|Klinik Bad Brambach|
|Bad Brambach, Saxony, Germany, D-08648|
|Principal Investigator:||Hans-Egbert Schröder, MD, Prof||Director III. Med. Hospital, University hospital, Technical University Dresden,|