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Completed

NCT Number: NCT00334620

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Klinik Bad Brambach

Bad Brambach, Saxony, D-08648, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

15 radon(+CO2) baths vs 15 CO2 baths; beside rehabilitation

Procedure

Primary outcomes

  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 outcomes

  1. pain intensity

  2. pain frequency

  3. morning stiffness

  4. functional capacity

  5. drug consumption (steroids; NSAIDs; DMARDs only descriptively)

Sponsors and collaborators

Lead sponsor

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

Other Gov

Collaborators

  • In-patient rehabilition hospital Klinik Bad Brambach
  • University hospital Dresden, III. Medical hospital and Outpatient clinic

Registry information

Important dates

Study start
1998
Study completion
2005
First posted
Jun 8, 2006
Registry last updated
Jun 8, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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