Full Text View
Tabular View
No Study Results Posted
Related Studies
Effectiveness of Radon Spa Therapy in Multimodal Rehabilitative Treatment of Rheumatoid Arthritis
This study has been completed.
Study NCT00334620   Information provided by Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
First Received: June 7, 2006   No Changes Posted

June 7, 2006
June 7, 2006
July 1998
 
  • 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)
Same as current
No Changes Posted
  • pain intensity
  • pain frequency
  • morning stiffness
  • functional capacity
  • drug consumption (steroids; NSAIDs; DMARDs only descriptively)
Same as current
 
Effectiveness of Radon Spa Therapy in Multimodal Rehabilitative Treatment of Rheumatoid Arthritis
 

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.

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.

Phase IV
Interventional
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Rheumatoid Arthritis
Procedure: 15 radon(+CO2) baths vs 15 CO2 baths; beside rehabilitation
 
Franke A, Reiner L, Pratzel HG, Franke T, Resch KL. Long-term efficacy of radon spa therapy in rheumatoid arthritis--a randomized, sham-controlled study and follow-up. Rheumatology (Oxford). 2000 Aug;39(8):894-902.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
140
May 2005
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00334620
 
BB-3I_1998
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
  • In-patient rehabilition hospital Klinik Bad Brambach
  • University hospital Dresden, III. Medical hospital and Outpatient clinic
Principal Investigator: Hans-Egbert Schröder, MD, Prof Director III. Med. Hospital, University hospital, Technical University Dresden,
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP