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

NCT00334620 | Completed Phase 4

• 1 other identifier: BB-3I_1998
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

randomised double-blinded trial; rehabilitation; radon spa therapy; long-term effectiveness

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• pain intensity

• pain frequency

• morning stiffness

• functional capacity

• drug consumption (steroids; NSAIDs; DMARDs only descriptively)

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster: lead
• In-patient rehabilition hospital Klinik Bad Brambach: collaborator
• University hospital Dresden, III. Medical hospital and Outpatient clinic: collaborator

Study Sites (1)

Klinik Bad Brambach

Bad Brambach, Saxony, D-08648, Germany

Location

Related Publications (1)

• 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.

  PMID: 10952746 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hans-Egbert Schröder, MD, Prof

  Director III. Med. Hospital, University hospital, Technical University Dresden,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 7, 2006
• First Posted: June 8, 2006
• Study Start: July 1, 1998
• Study Completion: May 1, 2005
• Last Updated: June 8, 2006

Record last verified: 2005-11

Locations

DE (1)