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| Descriptive Information Fields | |||||
| Brief Title † | Effectiveness of Radon Spa Therapy in Multimodal Rehabilitative Treatment of Rheumatoid Arthritis | ||||
| Official Title † | |||||
| 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. |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | 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) |
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| Secondary Outcome Measure † | pain intensity pain frequency morning stiffness functional capacity drug consumption (steroids; NSAIDs; DMARDs only descriptively) |
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| Condition † | Rheumatoid Arthritis | ||||
| Intervention † | Procedure: 15 radon(+CO2) baths vs 15 CO2 baths; beside rehabilitation | ||||
| MEDLINE PMIDs | 10952746 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 140 | ||||
| Start Date † | July 1998 | ||||
| Completion Date | May 2005 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Germany | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00334620 | ||||
| Organization ID | BB-3I_1998 | ||||
| Secondary IDs †† | |||||
| Study 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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| Investigators † |
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| Information Provided By | Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster | ||||
| Verification Date | November 2005 | ||||
| First Received Date † | June 7, 2006 | ||||
| Last Updated Date | June 7, 2006 | ||||