Effectiveness of Radon Spa Therapy in Multimodal Rehabilitative Treatment of Rheumatoid Arthritis - Full Text View

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
Information provided by:	Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
ClinicalTrials.gov Identifier:	NCT00334620

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Procedure: 15 radon(+CO2) baths vs 15 CO2 baths; beside rehabilitation	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Radon Rehabilitation Rheumatoid Arthritis

Drug Information available for: Radon Carbon dioxide

U.S. FDA Resources

Further study details as provided by Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	140
Study Start Date:	July 1998
Estimated Study Completion Date:	May 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334620

Locations

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

Sponsors and Collaborators

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

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,

More Information

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.

Study ID Numbers:	BB-3I_1998
Study First Received:	June 7, 2006
Last Updated:	June 7, 2006
ClinicalTrials.gov Identifier:	NCT00334620 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster:

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

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 30, 2009