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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Procedure: 15 radon(+CO2) baths vs 15 CO2 baths; beside rehabilitation

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 Type: Interventional
• Enrollment: 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Bad Brambach, Saxony, Germany, D-08648
      • Klinik Bad Brambach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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 Measures

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

Collaborators and Investigators

• 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,

Publications and helpful links

General Publications

• 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. doi: 10.1093/rheumatology/39.8.894.

Study record dates

Study Major Dates

• Study Start: July 1, 1998
• Study Completion: May 1, 2005

Study Registration Dates

• First Submitted: June 7, 2006
• First Submitted That Met QC Criteria: June 7, 2006
• First Posted (Estimate): June 8, 2006

Study Record Updates

• Last Update Posted (Estimate): June 8, 2006
• Last Update Submitted That Met QC Criteria: June 7, 2006
• Last Verified: November 1, 2005

More Information

Terms related to this study

• Keywords: rehabilitation; randomised double-blinded trial; radon spa therapy; long-term effectiveness
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: BB-3I_1998