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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
15 radon(+CO2) baths vs 15 CO2 baths; beside rehabilitation
Sponsored by
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring randomised double-blinded trial, rehabilitation, radon spa therapy, long-term effectiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Klinik Bad Brambach

Outcomes

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)

Full Information

First Posted
June 7, 2006
Last Updated
June 7, 2006
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
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1. Study Identification

Unique Protocol Identification Number
NCT00334620
Brief Title
Effectiveness of Radon Spa Therapy in Multimodal Rehabilitative Treatment of Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
randomised double-blinded trial, rehabilitation, radon spa therapy, long-term effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
140 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
15 radon(+CO2) baths vs 15 CO2 baths; beside rehabilitation
Primary Outcome Measure Information:
Title
limitations in everyday life and private activities
Title
limitations in the occupational context (not for pensioners)
Title
(both self-assessed on 2 100mm-VAS, averaged into 1 criterion if applicable)
Secondary Outcome Measure Information:
Title
pain intensity
Title
pain frequency
Title
morning stiffness
Title
functional capacity
Title
drug consumption (steroids; NSAIDs; DMARDs only descriptively)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Egbert Schröder, MD, Prof
Organizational Affiliation
Director III. Med. Hospital, University hospital, Technical University Dresden,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik Bad Brambach
City
Bad Brambach
State/Province
Saxony
ZIP/Postal Code
D-08648
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
10952746
Citation
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.
Results Reference
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Learn more about this trial

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

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