Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-04 @ 8:19 PM
Study NCT ID:
NCT03840304
Status:
COMPLETED
Last Update Posted:
2019-02-21
First Post:
2019-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Yoga@Work Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2019-02-09', 'studyFirstSubmitQcDate': '2019-02-11', 'lastUpdatePostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale for pain', 'timeFrame': 'change from baseline to 8 weeks', 'description': '100-mm visual analog scale (VAS), horizontal line ranging from 0mm (no pain) to 100mm (worst imaginable pain).'}], 'secondaryOutcomes': [{'measure': 'Neck disability index (NDI)', 'timeFrame': 'Change from baseline to 8-weeks', 'description': 'The NDI is a standard instrument for measuring self-rated disability due to neck pain.10-item, 50-point index; each of the 10 items is scored from 0 - 5. Higher points represent worse pain'}, {'measure': 'Shoulder pain disability index', 'timeFrame': 'Change from baseline to 8-weeks', 'description': 'The SPADI is a 13-item patient completed instrument. Its categories include pain (5 items) and disability (8 items), overall total scores range from 0 to 130. Higher score represent worse disability'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Musculoskeletal Pain', 'Neck Pain', 'Shoulder Pain']}, 'descriptionModule': {'briefSummary': 'Employees working in IT industry are prone to develop musculoskeletal pain,specifically back, neck and shoulder pain. This study evaluates the effectiveness of work-site yoga intervention, Yoga@work on neck and shoulder pain in IT employees.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IT companies employee\n* Full time employment\n* Neck and Shoulder Pain\n* pain of at least 3 months duration\n* able to comply with intervention schedule\n\nExclusion Criteria:\n\n* Pregnancy\n* Refuse to give informed consent\n* spinal fracture\n* recent cervical spine or shoulder surgery\n* recent (3 months) chemotherapy/radiotherapy/ intervention'}, 'identificationModule': {'nctId': 'NCT03840304', 'briefTitle': 'Effect of Yoga@Work Program', 'organization': {'class': 'OTHER', 'fullName': 'NMP Medical Research Institute'}, 'officialTitle': 'Effectiveness of Yoga@Work Program on Neck and Shoulder Pain in Information Technology (IT) Employees', 'orgStudyIdInfo': {'id': 'NMP 0198'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yoga Group', 'description': 'Participants in the intervention group engaged in a 8-week yoga program delivered at their place of work (IT companies). Sessions were group-based, prescribed three sessions per week during break time (30-mins).', 'interventionNames': ['Other: Yoga@work']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list Group', 'description': 'Participants in Wait-List control were not given any intervention. 8-weeks, group followed usual break time.'}], 'interventions': [{'name': 'Yoga@work', 'type': 'OTHER', 'otherNames': ['Yoga'], 'description': 'Each session included warm-up practices(for the large joints, spine, and extremities), Physical postures (Asana), breathing exercises (pranayama) and supine meditation/relaxation (savasana).', 'armGroupLabels': ['Yoga Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'NMP Medical Reserach Institute', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}], 'overallOfficials': [{'name': 'Neha Sharma', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yog-Kulam'}, {'name': 'Durga Prasad Sharma', 'role': 'STUDY_CHAIR', 'affiliation': 'International Labour Organization, UN'}, {'name': 'Divya Gaur', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NMP Medical Research Institute, India'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NMP Medical Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Warwick Research Services', 'class': 'OTHER'}, {'name': 'Yog-Kulam', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}