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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00334620
First received: June 7, 2006
Last updated: NA
Last verified: November 2005
History: No changes posted
  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 4

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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,
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00334620     History of Changes
Other Study ID Numbers: BB-3I_1998
Study First Received: June 7, 2006
Last Updated: June 7, 2006
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:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2014