Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334620
Status:
COMPLETED
Last Update Posted:
2006-06-08
First Post:
2006-06-07
Brief Title:
Effectiveness of Radon Spa Therapy in Multimodal Rehabilitative Treatment of Rheumatoid Arthritis
Sponsor:
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Organization:
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 pGME15 pGxC016 9 months pGME11 pGxC025 12 months pGME17 pGxC033 Furthermore consumption of steroids and NSAID was remarkably reduced in the Radon group RM-ANCOVA until 12 months for steroids pGME064 interaction pGxC025 maximum difference after 12 months for NSAID pGME035 interaction pGxC008 maximum difference after 9 months
Conclusion Results suggest beneficial long-term effects of Radon baths as adjunct to a multimodal rehabilitative treatment of RA
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 pGME15 pGxC016 9 months pGME11 pGxC025 12 months pGME17 pGxC033 Furthermore consumption of steroids and NSAID was remarkably reduced in the Radon group RM-ANCOVA until 12 months for steroids pGME064 interaction pGxC025 maximum difference after 12 months for NSAID pGME035 interaction pGxC008 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None