Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT00334620
Status:
COMPLETED
Last Update Posted:
2006-06-08
First Post:
2006-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Radon Spa Therapy in Multimodal Rehabilitative Treatment of Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'completionDateStruct': {'date': '2005-05'}, 'lastUpdateSubmitDate': '2006-06-07', 'studyFirstSubmitDate': '2006-06-07', 'studyFirstSubmitQcDate': '2006-06-07', 'lastUpdatePostDateStruct': {'date': '2006-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'limitations in everyday life and private activities'}, {'measure': 'limitations in the occupational context (not for pensioners)'}, {'measure': '(both self-assessed on 2 100mm-VAS, averaged into 1 criterion if applicable)'}], 'secondaryOutcomes': [{'measure': 'pain intensity'}, {'measure': 'pain frequency'}, {'measure': 'morning stiffness'}, {'measure': 'functional capacity'}, {'measure': 'drug consumption (steroids; NSAIDs; DMARDs only descriptively)'}]}, 'conditionsModule': {'keywords': ['randomised double-blinded trial', 'rehabilitation', 'radon spa therapy', 'long-term effectiveness'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '10952746', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The study aimed to investigate effects of radon (plus CO2) baths on RA in contrast to artificial CO2 baths in RA rehabilitation.\n\n134 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.\n\nSuperiority 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.', 'detailedDescription': "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.\n\nMethods: 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.\n\nResults: 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).\n\nConclusion: Results suggest beneficial long-term effects of Radon baths as adjunct to a multimodal rehabilitative treatment of RA."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rheumatoid arthritis according to the 1987 revised ACR criteria for RA\n\nExclusion Criteria:\n\n* current exacerbations of the inflammatory process\n* other systemic inflammatory diseases\n* concomitant musculo-skeletal diseases possibly interfering with outcome measurement,\n* pregnancy or breast feeding\n* disorders of the central nervous system\n* a known tendency toward thrombosis\n* malignant hypertension\n* coronary heart disease\n* heart failure, arrhythmia\n* severe disorders of lungs, kidneys, or liver\n* advanced malignancies\n* abuse of alcohol or drugs,\n* major skin lesions,\n* severe fever, or infections.'}, 'identificationModule': {'nctId': 'NCT00334620', 'briefTitle': 'Effectiveness of Radon Spa Therapy in Multimodal Rehabilitative Treatment of Rheumatoid Arthritis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster'}, 'orgStudyIdInfo': {'id': 'BB-3I_1998'}}, 'armsInterventionsModule': {'interventions': [{'name': '15 radon(+CO2) baths vs 15 CO2 baths; beside rehabilitation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-08648', 'city': 'Bad Brambach', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Klinik Bad Brambach', 'geoPoint': {'lat': 50.21667, 'lon': 12.31667}}], 'overallOfficials': [{'name': 'Hans-Egbert Schröder, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director III. Med. Hospital, University hospital, Technical University Dresden,'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'In-patient rehabilition hospital Klinik Bad Brambach', 'class': 'UNKNOWN'}, {'name': 'University hospital Dresden, III. Medical hospital and Outpatient clinic', 'class': 'OTHER'}]}}}