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

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ClinicalTrials.gov Identifier: NCT00334620
Recruitment Status : Completed
First Posted : June 8, 2006
Last Update Posted : June 8, 2006
Sponsor:
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

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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Procedure: 15 radon(+CO2) baths vs 15 CO2 baths; beside rehabilitation Phase 4

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  (Clinical Trial)
Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : July 1998
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. limitations in everyday life and private activities
  2. limitations in the occupational context (not for pensioners)
  3. (both self-assessed on 2 100mm-VAS, averaged into 1 criterion if applicable)

Secondary Outcome Measures :
  1. pain intensity
  2. pain frequency
  3. morning stiffness
  4. functional capacity
  5. drug consumption (steroids; NSAIDs; DMARDs only descriptively)


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334620


Locations
Germany
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,

Publications:
ClinicalTrials.gov Identifier: NCT00334620     History of Changes
Other Study ID Numbers: BB-3I_1998
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: June 8, 2006
Last Verified: November 2005

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:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases