Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-02-28 @ 6:47 PM
Study NCT ID:
NCT04466605
Status:
COMPLETED
Last Update Posted:
2020-07-10
First Post:
2020-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011320', 'term': 'Primary Health Care'}], 'ancestors': [{'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-09', 'studyFirstSubmitDate': '2020-07-09', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of pain', 'timeFrame': 'From baseline to 6-week post intervention', 'description': 'Pain was assessed using the Brief Pain Inventory (BPI), which rates the severity of pain on 4 items (current, worst, least, and average pain in past week)'}, {'measure': 'Interference of pain', 'timeFrame': 'From baseline to 6-week post intervention', 'description': 'Interference of pain in 7 areas (mood, physical activity, work, social activity, relations with others, sleep, enjoyment of life) were reported using BPI'}], 'secondaryOutcomes': [{'measure': 'Global rating of change in pain', 'timeFrame': 'From baseline to 6-week post interventiona', 'description': '7-point global rating of pain change was used to assess change in pain'}, {'measure': 'Intervention specific satisfaction', 'timeFrame': 'From baseline to 6-week post interventiona', 'description': '10 point scale was used to assess intervention-specific satisfaction'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tele-Yoga Therapy', 'Chronic musculoskeletal pain', 'Randomized controlled trial'], 'conditions': ['Chronic Musculoskeletal Pain']}, 'descriptionModule': {'briefSummary': 'Covid-19 outbreak and lockdown measures raised significant concerns over clinical management of chronic pain patients around the world. Patients with chronic musculoskeletal pain (CMSP) are at high risk of physical disability, psychological distress, and poor quality of life. Analgesic medications were main management during lockdown, but opioid-related concerns have prompted to find immediate alternatives.\n\nPresent study was undertaken to determine whether patients randomized to tele-yoga therapy would experience less pain, disability and improved global health, adherence and satisfaction, compared with patients assigned to usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having pain that was musculoskeletal, defined as regional (joints, limbs, back, neck) or more generalized (fibromyalgia or chronic widespread pain);\n* Persistent pain ( ≥3 months) despite trying conventional treatment.\n* Access to virtual platform with internet.\n* Ready to give informed consent\n\nExclusion Criteria:\n\n* Schizophrenia,\n* Psychiatric disorder\n* Cognitive impairment\n* Suicidal ideation\n* Current illicit drug use\n* Terminal illness'}, 'identificationModule': {'nctId': 'NCT04466605', 'briefTitle': 'Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown', 'organization': {'class': 'OTHER', 'fullName': 'Aarogyam UK'}, 'officialTitle': 'Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'AU/NMP/0921'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tele-Yoga Therapy', 'description': 'All patients randomized to the intervention group had one to one yoga sessions with yoga therapist twice a week for 45 minutes on secure virtual platform. Patients were encouraged with home practice to follow everyday at least for 30-mins.', 'interventionNames': ['Other: Tele-yoga therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Patients randomized to usual care continued to receive care for their chronic musculoskeletal pain from their primary care physician. There was no attempt by to influence clinical management unless an emergency arose', 'interventionNames': ['Other: Primary care']}], 'interventions': [{'name': 'Tele-yoga therapy', 'type': 'OTHER', 'description': 'Each session included combinations of different yoga exercises, postures, yoga breathing, yoga relaxation techniques, yoga counselling and meditative practices based on individualisation.', 'armGroupLabels': ['Tele-Yoga Therapy']}, {'name': 'Primary care', 'type': 'OTHER', 'description': 'Patients will follow standard care provided by primary care physicians including analgesics and self care management.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'NMP Medical Research Institute', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}], 'overallOfficials': [{'name': 'Naveen Meghwal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NMP Medical Research Institute, India'}, {'name': 'Neha Sharma', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aarogyam UK'}, {'name': 'Bhavna Pandya', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarogyam UK'}, {'name': 'Abhimanyu Kumar', 'role': 'STUDY_CHAIR', 'affiliation': 'Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarogyam UK', 'class': 'OTHER'}, 'collaborators': [{'name': 'NMP Medical Research Institute', 'class': 'OTHER'}, {'name': 'Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}