Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-01-01 @ 8:08 PM
Study NCT ID:
NCT02020668
Status:
UNKNOWN
Last Update Posted:
2014-05-07
First Post:
2013-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Physiotherapy on the Health and Quality of Life of the Rheumatic Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012213', 'term': 'Rheumatic Fever'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-06', 'studyFirstSubmitDate': '2013-12-19', 'studyFirstSubmitQcDate': '2013-12-24', 'lastUpdatePostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Functional capacity', 'timeFrame': 'Change from baseline in Barthel Index at 16 weeks'}], 'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Change from baseline in Numerical Scale Downie at 16 weeks'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'Change from Baseline in Short Form (SF) 36 at 16 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pain', 'Functional capacity', 'Quality of Life'], 'conditions': ['Rheumatic Arthritis']}, 'descriptionModule': {'briefSummary': 'Despite leading cause of morbidity, treatment strategies for Rheumatic diseases are geared almost exclusively toward medical-pharmacological area away from offering the patient the possibility of an interdisciplinary approach to their disease.\n\nPresent study test whether treatment of physiotherapy reduces stiffness and pain inherent in rheumatic disease and improve their quality of life related to health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years\n* History of Rheumatoid Arthritis (RA) symptoms for less than 7 years\n* Had RA by American College of Rheumatology (ACR) criteria\n* ACR functional RA class I, II or III\n* Hemoglobin more than 8g/dL without evidence of active bleeding\n* Positive for rheumatoid factor (RF) or anti cyclic citrullinated protein\n* standard conventional medicine were allowed within the approved dosage regimen\n\nExclusion Criteria:\n\n* connective tissue disease\n* any other alternative or complementary medicine with in last 3 months.\n* corticosteroid, disease modifying medicines\n* Poorly controlled diabetes, hypertension, hepatitis, cardiac disease, liver diseases, carcinoma, drug abuse'}, 'identificationModule': {'nctId': 'NCT02020668', 'briefTitle': 'Efficacy of Physiotherapy on the Health and Quality of Life of the Rheumatic Patient', 'organization': {'class': 'INDUSTRY', 'fullName': 'Macmillan Research Group UK'}, 'officialTitle': 'Phase II Study of Physiotherapy in Rheumatoid Arthritis: Randomized Single Blind Wait-list Controlled Trial', 'orgStudyIdInfo': {'id': 'Mac/NMP 1210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physiotherapy', 'description': 'Physiotherapy included joint protection strategies, performance of therapeutic exercises and patient education.', 'interventionNames': ['Other: Physiotherapy']}, {'type': 'OTHER', 'label': 'Wait list control', 'description': 'Wait list control received standard care and were invited to join the physiotherapy once intervention period is finished.', 'interventionNames': ['Other: Wait list control']}], 'interventions': [{'name': 'Physiotherapy', 'type': 'OTHER', 'armGroupLabels': ['Physiotherapy']}, {'name': 'Wait list control', 'type': 'OTHER', 'armGroupLabels': ['Wait list control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sīkar', 'state': 'Rajasthan', 'country': 'India', 'contacts': [{'name': 'Deepika Ratan', 'role': 'CONTACT', 'phone': '9413623113'}], 'facility': 'Life Line Hospital', 'geoPoint': {'lat': 27.61206, 'lon': 75.13996}}], 'centralContacts': [{'name': 'Virendra Shekhawat, MA', 'role': 'CONTACT', 'email': 'shekhawatvans21@gmail.com', 'phone': '+91-8824260512'}], 'overallOfficials': [{'name': 'Neha Sharma, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Macmillan Research Group'}, {'name': 'Om Prakash Sharma, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Life Line Hospital, Sikar, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Macmillan Research Group UK', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'NMP Medical Research Institute', 'class': 'OTHER'}, {'name': 'Warwick Research Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}