Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-28 @ 12:47 AM
Study NCT ID:
NCT06062459
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2023-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synergistic Benefits of MCE and BT in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-25', 'studyFirstSubmitDate': '2023-09-25', 'studyFirstSubmitQcDate': '2023-09-25', 'lastUpdatePostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '6 Weeks', 'description': "The pain intensity was assessed Using a numeric pain rating scale (NPRS), It's a 11 point scale, where zero indicates no pain and 10 indicates severe pain"}, {'measure': 'Functional disability', 'timeFrame': '6 Weeks', 'description': 'Functional limitation was assessed by using Oswestry disability Index questionnaire Each section is scored on a 0-5 scale, 5 representing the greatest disability.'}, {'measure': 'self-reported measure of health', 'timeFrame': '6 Weeks', 'description': 'It comprises 36 questions that cover eight domains of health'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sacroiliac Joint Dysfunction']}, 'descriptionModule': {'briefSummary': 'This research aimed to ascertain the combined and individual efficacies of MCE and BT in alleviating SIJD symptoms.', 'detailedDescription': 'The study will be based on a four-arm parallel group randomized control design. one hundred and twenty participants with SIJD will be recruited from the Physiotherapy department, at Integral University, India. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly divided into four groups A, B, C, and D. Experimental group A will be receiving the hot pack, Stretching exercise, and MCE intervention, group B will receive the hot pack, Stretching exercise, and BT exercise and Group C will be receiving the hot pack, Stretching exercise, and MCE \\& BT intervention, control group D will receive the hot pack, Stretching exercise intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age-30-60 Years\n* sacroiliac joint pain (\\>3 months)\n* Presence of pain exacerbated as a result of bending laterally or backward\n* Positive results on at least 2 of the pain-provocation tests \\[FABER, Posterior shear and Gaenslen pain provocation tests) and one of the motion palpation tests (ie, Gillet and forward flexion tests)\n\nExclusion Criteria:\n\n* past or current history of surgery or major trauma to spine, pelvis, lower limb, chest or abdomen in the past 12 months\n* lower extremity musculoskeletal disorders; known localized spinal pathology\n* known congenital anomalies of hip, pelvis or spine that limits mobility\n* known systematic arthropathy, neuropathy or metabolic disorder\n* Presence of other causes of LBP such as lumbar discopathy and spinal stenosis discovered via clinical examination and MRI scanning\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT06062459', 'briefTitle': 'Synergistic Benefits of MCE and BT in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Najran University'}, 'officialTitle': 'Synergistic Benefits of Motor Control Exercises and Balance Training in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IE/IIMS&R/2022/87'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'MCE Group', 'interventionNames': ['Other: Motor Control Exercise', 'Other: Control Group']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'BT Group', 'interventionNames': ['Other: Balance Training', 'Other: Control Group']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'Combined MCE \\& BT Group', 'interventionNames': ['Other: Motor Control Exercise', 'Other: Balance Training', 'Other: Control Group']}, {'type': 'OTHER', 'label': 'Group D', 'description': 'Control Group', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'Motor Control Exercise', 'type': 'OTHER', 'description': 'Motor control exercises focusing on the activation and control of deep spinal muscles', 'armGroupLabels': ['Group A', 'Group C']}, {'name': 'Balance Training', 'type': 'OTHER', 'description': 'Balance training exercises on to enhance proprioception and stability', 'armGroupLabels': ['Group B', 'Group C']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'Participants received hot pack and stretching exercise', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lucknow', 'state': 'Uttar Pardesh', 'country': 'India', 'facility': 'Integral University Hospital', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '1988', 'city': 'Najrān', 'state': 'Najran Region', 'country': 'Saudi Arabia', 'facility': 'Hashim Ahmed', 'geoPoint': {'lat': 17.49326, 'lon': 44.12766}}], 'overallOfficials': [{'name': 'Hashim Ahmed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Najran University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Najran University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hashim Ahmed', 'investigatorAffiliation': 'Najran University'}}}}