跳至主要内容
临床试验/NCT00334620
NCT00334620已完成4 期

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

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 1998年7月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
140
试验地点
2
主要终点
limitations in everyday life and private activities

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Rheumatoid arthritis according to the 1987 revised ACR criteria for RA

排除标准

  • 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.

结局指标

主要结局

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)

次要结局

  • pain intensity
  • pain frequency
  • morning stiffness
  • functional capacity
  • drug consumption (steroids; NSAIDs; DMARDs only descriptively)

研究者

发起方
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
申办方类型
Other Gov

研究点 (2)

Loading locations...

相似试验