Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 5:59 AM
Study NCT ID:
NCT01920360
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2013-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation Study of the Effects of Sulphurous Water in the Treatment of Knee Osteoarthritis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001452', 'term': 'Balneology'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-10', 'studyFirstSubmitDate': '2013-08-01', 'studyFirstSubmitQcDate': '2013-08-08', 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': '10 weeks', 'description': 'Tools:\n\nWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC): 5 questions about pain, 2 about stiffness, 17 about physical function. Each question receives a score from 0 to 100. After is done the arithmetic mean. The higher the score on each subscale, the greater deficit.\n\nVisual Analogic Scale (VAS): horizontal line marked from 0 (no pain) to 10 (intense pain).\n\nLEQUESNE: 11 questions about pain, discomfort and function, 6 about pain and discomfort, 1 about to walk away, and 4 on daily activities. The scores range from 0 (no impairment) to 24 (severe).\n\nShort Form-36 (SF-36): 36 items grouped into eight areas. The final score from 0 (worst quality) to 100 (the best).'}, {'measure': 'Life Quality', 'timeFrame': '10 weeks', 'description': 'Tools:\n\nShort Form-36 (SF-36): 36 items grouped into eight areas. The final score from 0 (worst quality) to 100 (the best).'}, {'measure': 'Physical Function', 'timeFrame': '10 weeks', 'description': 'Tools:\n\nWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC): 5 questions about pain, 2 about stiffness, 17 about physical function. Each question receives a score from 0 to 100. After is done the arithmetic mean. The higher the score on each subscale, the greater deficit.\n\nLEQUESNE: 11 questions about pain, discomfort and function, 6 about pain and discomfort, 1 about to walk away, and 4 on daily activities. The scores range from 0 (no impairment) to 24 (severe).\n\nHealth Assessment Questionnaire (HAQ): Each question ranges from zero (no functional impairment) to three (task disabling).\n\nShort Form-36 (SF-36): 36 items grouped into eight areas. The final score from 0 (worst quality) to 100 (the best).'}], 'secondaryOutcomes': [{'measure': 'Intake of pain medication', 'timeFrame': '10 weeks', 'description': 'After randomization, patients were instructed to report home about taking medication for pain in the knees, noting in a spreadsheet every time you wear some medicine to relieve pain in the knees. The result of this analysis was based on the number of times each individual ingested some medication.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['KNEE OSTEOARTHRITIS', 'BALNEOTHERAPY', 'SULPHUROUS WATERS', 'WOMAC', 'LEQUESNE', 'HEALTH ASSESSMENT QUESTIONNAIRE', 'SHORT FORM - 36', 'VAS'], 'conditions': ['KNEE OSTEOARTHRITIS']}, 'referencesModule': {'references': [{'pmid': '17943920', 'type': 'BACKGROUND', 'citation': 'Verhagen AP, Bierma-Zeinstra SM, Boers M, Cardoso JR, Lambeck J, de Bie RA, de Vet HC. Balneotherapy for osteoarthritis. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006864. doi: 10.1002/14651858.CD006864.'}, {'pmid': '16832639', 'type': 'RESULT', 'citation': 'Yurtkuran M, Yurtkuran M, Alp A, Nasircilar A, Bingol U, Altan L, Sarpdere G. Balneotherapy and tap water therapy in the treatment of knee osteoarthritis. Rheumatol Int. 2006 Nov;27(1):19-27. doi: 10.1007/s00296-006-0158-8. Epub 2006 Jul 11.'}]}, 'descriptionModule': {'briefSummary': 'The objectives are to evaluate the effects of immersion bath with sulphurous water in pain, joint mobility and quality of life in patients with knee osteoarthritis. Patients will undergo three weekly baths in sulphurous water and not sulphurous, twenty minutes each, for ten weeks.\n\nThe expected results are: reduction of pain, improved range of motion of the lower limbs with consequent increase in muscle mass improvement in postural balance, which will come due to the reduction of pain and improvement movements of the lower limbs; greater independence in performing the activities of daily living, better quality of life.', 'detailedDescription': 'The baths were performed in individual tubs, properly disinfected, supplied with thermal water and sulphurous thermal sulphurous not at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects drank two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water. Treatment consisted of 30 individual treatment sessions, three times a week, lasting twenty minutes each session, for ten weeks. The experiment was performed at the Therms Antonio Carlos, institution belonging to the Municipality of Poços de Caldas, Minas Gerais, Brazil.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWe selected individuals of both genders, diagnosed with Osteoarthritis of the knee according to the classification criteria of the American College of Rheumatology (ACR) only grades I to III chronic pain at some knees, for a minimum period of three months.\n\nExclusion Criteria:\n\n* Patients with fibromyalgia;\n* Individuals with respiratory diseases;\n* Rheumatic diseases autoimmune inflammatory;\n* Patients with uncontrolled thyroidopathies;\n* Patients with injuries or amputations of lower limbs;\n* Patients with psychiatric disorders or cognitive;\n* Patients with a history of osteoporotic fracture;\n* Patients with malignant\n* Patients with infectious processes;\n* Patients pregnant;\n* Individuals who failed to enter the baths due to physical limitations;\n* Were also excluded those who were engaged in other forms of treatment or using painkillers and anti-inflammatory drugs for other diseases. Note: were not excluded participants who were diagnosed with osteoarthritis in the spine, herniated, or degenerative disc protrusions.'}, 'identificationModule': {'nctId': 'NCT01920360', 'briefTitle': 'Evaluation Study of the Effects of Sulphurous Water in the Treatment of Knee Osteoarthritis.', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Study of the Effects of Immersion Baths in Sulphurous Water in Patients With Knee Osteoarthritis: Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': '65463'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SULPHUROUS WATERS IMMERSION BATHS', 'description': 'The baths will be held in individual tubs, properly disinfected, supplied with sulphurous thermal water at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects will drink two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water.', 'interventionNames': ['Other: SULPHUROUS WATERS IMMERSION BATHS']}, {'type': 'EXPERIMENTAL', 'label': 'NOT SULPHUROUS WATERS IMMERSION BATHS', 'description': 'The baths will be held in individual tubs, properly disinfected, supplied with not sulphurous thermal water at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects will drink two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water.', 'interventionNames': ['Other: NOT SULPHUROUS WATERS IMMERSION BATHS']}, {'type': 'EXPERIMENTAL', 'label': 'CONTROL GROUP', 'description': 'This group did not receive any treatment, only received some verbal directions as to the care that should be taken to prevent and control the knee pain.', 'interventionNames': ['Other: CONTROL GROUP']}], 'interventions': [{'name': 'SULPHUROUS WATERS IMMERSION BATHS', 'type': 'OTHER', 'otherNames': ['Balneotherapy', 'Termalism'], 'description': 'SULPHUROUS WATERS IMMERSION BATHS: The baths will be held in individual tubs, properly disinfected, supplied with sulphurous thermal water at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects will drink two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water.', 'armGroupLabels': ['SULPHUROUS WATERS IMMERSION BATHS']}, {'name': 'NOT SULPHUROUS WATERS IMMERSION BATHS', 'type': 'OTHER', 'otherNames': ['Balneotherapy', 'Termalism'], 'description': 'NOT SULPHUROUS WATERS IMMERSION BATHS:The baths will be held in individual tubs, properly disinfected, supplied with not sulphur thermal water at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects will drink two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water.', 'armGroupLabels': ['NOT SULPHUROUS WATERS IMMERSION BATHS']}, {'name': 'CONTROL GROUP', 'type': 'OTHER', 'description': 'CONTROL GROUP: This group did not receive any treatment, only received some verbal directions as to the care that should be taken to prevent and control the knee pain.', 'armGroupLabels': ['CONTROL GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37701-000', 'city': 'Poços de Caldas', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Therms Antonio Carlos', 'geoPoint': {'lat': -21.78778, 'lon': -46.56139}}], 'overallOfficials': [{'name': 'Marcelo Branco', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo UNIFESP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'physiotherapist', 'investigatorFullName': 'Marcelo Branco', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}