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

This study has been completed.
Study NCT00334620.   Last updated on June 7, 2006.   Information provided by Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

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Descriptive Information Fields
Brief Title  Effectiveness of Radon Spa Therapy in Multimodal Rehabilitative Treatment of Rheumatoid Arthritis
Official Title 
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 Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  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 Measure  pain intensity
pain frequency
morning stiffness
functional capacity
drug consumption (steroids; NSAIDs; DMARDs only descriptively)
Condition  Rheumatoid Arthritis
Intervention  Procedure: 15 radon(+CO2) baths vs 15 CO2 baths; beside rehabilitation
MEDLINE PMIDs 10952746
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  140
Start Date  July 1998
Completion Date May 2005
Eligibility Criteria 

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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Germany
Administrative Information Fields
NCT ID  NCT00334620
Organization ID BB-3I_1998
Secondary IDs ††
Study Sponsor  Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Collaborators †† In-patient rehabilition hospital Klinik Bad Brambach
University hospital Dresden, III. Medical hospital and Outpatient clinic
Investigators 
Principal Investigator:     Hans-Egbert Schröder, MD, Prof     Director III. Med. Hospital, University hospital, Technical University Dresden,    
Information Provided By Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Verification Date November 2005
First Received Date  June 7, 2006
Last Updated Date June 7, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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