Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-31 @ 9:35 AM
Study NCT ID:
NCT06913803
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-06
First Post:
2025-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Find Effectiveness of Stretching Versus Soft Tissue Mobilization in Coccydynia in Postpartum Females
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003047', 'term': 'Coccidioidomycosis'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-29', 'studyFirstSubmitDate': '2025-03-29', 'studyFirstSubmitQcDate': '2025-03-29', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NUMERIC PAIN RATING SCALE(NPRS)', 'timeFrame': '12 Months', 'description': 'The Numeric Pain Rating Scale (NPRS) is a widely used, 11-point scale (0-10) for measuring pain intensity, with 0 representing "no pain" and 10 representing "worst pain imaginable'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': '12 Months', 'description': 'The Oswestry Disability Index (ODI) scores disability levels related to low back pain on a scale of 0 to 100, with 0 indicating no disability and 100 representing the highest level of disability'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coccidioidomycosis']}, 'descriptionModule': {'briefSummary': 'This research is to determine the effectiveness of stretching versus soft tissue mobilization in coccydynia patients.The main purpose of the study is the the development of evidence based therapeutic protocols for postpartum coccydynia patients to improve functional impairment, range of motion, and reduction of pain.', 'detailedDescription': "The study design is randomized controlled trial.The interventions were carried out twice a week for three weeks with each session lasting approximately 20 min.Group A contains 34 patients and received STM focusing on mobilizing soft tissue to enhance circulation reduce scar tissue and improve functional flexibility.Group B received both STM and stretching twice a week for three weeks with each session lasting approximately 20 min.During entire treatment the therapist kept close eye on patient discomfort.The significance of the study lies in it's potential to enhance more effective non invasive treatment to alleviate symptoms"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed by orthopedic surgeon with sign and symptoms of coccydynia and radiograph X ray for confirmation.: postpartum females after 2 to 3 months after delivery\n* office working females\n* aged 20 to 35 years\n* females with c section\n\nExclusion Criteria:\n\n* FEMALES with vaginal delivery\n* experience severe post operative pain\n* active pelvic or abdominal infections\n* ovarian cyst, fibroids,or obstructive endometrial polyps\n* neurological conditions'}, 'identificationModule': {'nctId': 'NCT06913803', 'briefTitle': 'To Find Effectiveness of Stretching Versus Soft Tissue Mobilization in Coccydynia in Postpartum Females', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'To Find Effectiveness of Stretching Versus Soft Tissue Mobilization in Coccydynia in Postpartum Females', 'orgStudyIdInfo': {'id': 'MSRSW/Batch-Fall23/809'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stretching', 'interventionNames': ['Diagnostic Test: Stretching']}, {'type': 'EXPERIMENTAL', 'label': 'Soft Tissue Mobilization', 'interventionNames': ['Combination Product: Soft Tissue Mobilization']}], 'interventions': [{'name': 'Stretching', 'type': 'DIAGNOSTIC_TEST', 'description': 'The group A contains 34 patients and received STM for twice a week for three weeks with each session lasting approximately 20 min.focusing on mobilizing soft tissue to enhance circulation, reduce scar tissue and improve tissue flexibility.', 'armGroupLabels': ['Stretching']}, {'name': 'Soft Tissue Mobilization', 'type': 'COMBINATION_PRODUCT', 'description': 'Group B received both STM and stretching twice a week for three weeks with each session lasting approximately 20 min.encourage the patient to breathe deeply and slowly to promote relaxation.The stretching of tight muscles 1 set of 10 repetitions hold of 5 second of each exercise,then breathing for 1 min', 'armGroupLabels': ['Soft Tissue Mobilization']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Sir Ganga Ram Hospital Physiotherapy department , Mozang', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}