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

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334620
• Other study ID #: BB-3I_1998
• Status: Completed
• Phase: Phase 4
• First received: June 7, 2006
• Last updated: June 7, 2006
• Start date: July 1998
• Est. completion date: May 2005

Study information

• Verified date: November 2005
• Source: Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Germany	Klinik Bad Brambach	Bad Brambach	Saxony

Sponsors (3)

Lead Sponsor	Collaborator
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster	In-patient rehabilition hospital Klinik Bad Brambach, University hospital Dresden, III. Medical hospital and Outpatient clinic

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	limitations in everyday life and private activities
Primary	limitations in the occupational context (not for pensioners)
Primary	(both self-assessed on 2 100mm-VAS, averaged into 1 criterion if applicable)
Secondary	pain intensity
Secondary	pain frequency
Secondary	morning stiffness
Secondary	functional capacity
Secondary	drug consumption (steroids; NSAIDs; DMARDs only descriptively)