Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-02 @ 8:10 AM
Study NCT ID:
NCT06867003
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2025-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Exercise With & Without Bracing in Office Workers With Kyphosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007738', 'term': 'Kyphosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D001915', 'term': 'Braces'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'this study follows an analytical research model designed to compare effectiveness of Physical Therapy with and without Bracing on Posture, Pain, and Functional Outcomes in Office Workers with Kyphosis'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RCT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2025-03-04', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': '4 weeks', 'description': 'The questionnaire consists of 10 sections, each with 6 response options (scored 0 to 5). If all 10 sections are completed, the maximum score is 50.'}, {'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': '4 weeks', 'description': 'A 10 cm horizontal line with "No Pain" (0) on the left and "Worst Pain" (10) on the right.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kyphosis'], 'conditions': ['Kyphosis']}, 'descriptionModule': {'briefSummary': 'The study aims to Compare PT and bracing in improving posture, pain, and functionality in patient with kyphosis.\n\nIt also assess the additive benefits of combining PT with bracing. It also identify sustainable, non-surgical approaches for managing kyphosis in office', 'detailedDescription': 'The study focuses on understanding Kyphosis, defined as excessive forward curvature of the thoracic spine, has become increasingly prevalent in modern work environments due to the sedentary nature of desk jobs. Kyphosis, characterized by a rounded upper back or "hunchback" appearance, is a clinical and postural problem with significant physical, functional, and psychosocial implications. Among office workers, the condition is primarily postural, driven by long hours of desk work, inappropriate ergonomic settings, and inadequate postural awareness. The increasing prevalence of kyphosis in this demographic has led to a pressing need for effective nonsurgical management strategies, including physical therapy (PT) and spinal bracing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Office workers diagnosed with Postural Kyphosis\n* age limit 30 to 45years\n* Experience of upper back or neck pain lasting at least three months\n* Spend a minimum of 6 hours per day in a seated position for work.\n\nExclusion Criteria:\n\n* History of spinal surgery, severe scoliosis, or other significant spinal deformities.\n\nCurrent engagement in any structured physical therapy program or use of bracing for posture. Any neurological or musculoskeletal disorders impacting posture or movement.'}, 'identificationModule': {'nctId': 'NCT06867003', 'briefTitle': 'Comparison of Exercise With & Without Bracing in Office Workers With Kyphosis', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effectiveness of Physical Therapy With &Amp; Without Bracing on Posture, Pain and Functional Outcomes in Office Workers With Kyphosis', 'orgStudyIdInfo': {'id': 'REC-01009 Yasir Khan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical therapy with bracing', 'description': 'Effectiveness of physical therapy with bracing', 'interventionNames': ['Other: physical therapy with bracing']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'physical therapy without bracing', 'description': 'Effectiveness of physical therapy without bracing', 'interventionNames': ['Other: physical therapy without bracing']}], 'interventions': [{'name': 'physical therapy with bracing', 'type': 'OTHER', 'otherNames': ['Exercise'], 'description': 'Strengthens the upper back muscles and reduces tension:\n\n1. Stand or sit with an upright posture and shoulders pulled back\n2. Squeeze your shoulder blades together as tightly as you can and hold for five to ten seconds', 'armGroupLabels': ['Physical therapy with bracing']}, {'name': 'physical therapy without bracing', 'type': 'OTHER', 'description': 'Strengthens the upper back muscles and reduces tension:\n\n1. Stand or sit with an upright posture and shoulders pulled back\n2. Squeeze your shoulder blades together as tightly as you can and hold for five to ten seconds', 'armGroupLabels': ['physical therapy without bracing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23060', 'city': 'Malakand', 'state': 'KPK', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Ataur Rahman, MS', 'role': 'CONTACT', 'email': 'ataur.rahman@riphah.edu.pk', 'phone': '03038371112'}, {'name': 'Ataur Rahman, MS', 'role': 'CONTACT', 'email': 'ataur.rahman@riphah.edu.pk', 'phone': '0311015233'}], 'facility': 'Riphah international University malakand campus', 'geoPoint': {'lat': 34.56561, 'lon': 71.93043}}], 'centralContacts': [{'name': 'Ataur Rahman', 'role': 'CONTACT', 'email': 'ataur.rahman@riphah.edu.pk', 'phone': '03038371112'}], 'overallOfficials': [{'name': 'Ataur Rahman, MS-PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}