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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00334620
Enrollment
140
Registered
2006-06-08
Start date
1998-07-31
Completion date
2005-05-31
Last updated
2006-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

randomised double-blinded trial, rehabilitation, radon spa therapy, long-term effectiveness

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.

Interventions

PROCEDURE15 radon(+CO2) baths vs 15 CO2 baths; beside rehabilitation

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026