Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:24 AM
Study NCT ID:
NCT07468734
Status:
RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shock Wave Versus Traditional Physical Therapy for Adult Chronic Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain intensity', 'timeFrame': '5-week after intervention', 'description': 'Change in pain intensity will be assessed using the Visual Analogue Scale (VAS) which is a 10-cm horizontal line used to measure pain intensity, ranging from (0) "no pain" to (10) "worst imaginable pain".'}], 'secondaryOutcomes': [{'measure': 'Stiffness assessment', 'timeFrame': '5-week after intervention', 'description': 'Stiffness will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).\n\nWOMAC will be recorded at baseline, at the end of the intervention period, and during follow-up. Higher scores indicate greater symptom severity.'}, {'measure': 'Assessment of physical function', 'timeFrame': '5-week after intervention', 'description': 'Physical function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).\n\nWOMAC will be recorded at baseline, at the end of the intervention period, and during follow-up. Higher scores indicate greater symptom severity.'}, {'measure': 'Knee range of motion', 'timeFrame': '5-week after intervention', 'description': 'Knee range of motion (ROM) will be assessed.'}, {'measure': 'Incidence of adverse events', 'timeFrame': '5-week after intervention', 'description': 'Incidence of adverse events will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shock Wave', 'Traditional Physical Therapy', 'Chronic Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effectiveness of extracorporeal shock wave therapy (ESWT) versus structured therapeutic exercise in patients with chronic knee osteoarthritis (KOA), with respect to pain reduction and improvement of knee function.', 'detailedDescription': 'Knee osteoarthritis (KOA) is a highly prevalent chronic degenerative joint disease characterized by progressive cartilage loss, chronic pain, stiffness, functional disability, and reduced quality of life in adults, particularly the elderly.\n\nExtracorporeal shock wave therapy (ESWT) has emerged as a non-invasive physical modality that delivers acoustic pressure waves to musculoskeletal tissues, stimulating biological responses such as enhanced microcirculation, anti-inflammatory cytokine modulation, neovascularization, cartilage and bone repair processes, and decreased pain transmission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥ 40 years with clinical and radiographic diagnosis of chronic knee osteoarthritis (KOA) (Kellgren-Lawrence grade II-III).\n* Both sexes.\n* Persistent knee pain ≥ 3 months.\n* Ability to provide consent and participate in interventions.\n\nExclusion Criteria:\n\n* Prior knee surgery within last 6 months.\n* Intra-articular injections in the last 3 months.\n* Systemic inflammatory arthritis or other neurological conditions affecting gait.'}, 'identificationModule': {'nctId': 'NCT07468734', 'briefTitle': 'Shock Wave Versus Traditional Physical Therapy for Adult Chronic Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'German International University'}, 'officialTitle': 'Shock Wave Versus Traditional Physical Therapy for Adult Chronic Knee Osteoarthritis: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DCSR-02026-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESWT Group', 'description': 'Patients will receive extracorporeal shock wave therapy.', 'interventionNames': ['Other: Extracorporeal shock wave therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise Therapy Group', 'description': 'Patients will undergo a structured exercise therapy program.', 'interventionNames': ['Other: Exercise therapy program']}], 'interventions': [{'name': 'Extracorporeal shock wave therapy', 'type': 'OTHER', 'description': 'Patients will receive extracorporeal shock wave therapy.', 'armGroupLabels': ['ESWT Group']}, {'name': 'Exercise therapy program', 'type': 'OTHER', 'description': 'Patients will undergo a structured exercise therapy program.', 'armGroupLabels': ['Exercise Therapy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Shabana, MD', 'role': 'CONTACT', 'email': 'magdy.shabana@giu-uni.de', 'phone': '00201006053332'}], 'facility': 'German International University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Magdy M Shabana, MD', 'role': 'CONTACT', 'email': 'magdy.shabana@giu-uni.de', 'phone': '00201006053332'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor in Orthopedic, Physical Therapy', 'investigatorFullName': 'Magdy Mohamed Aly Shabana', 'investigatorAffiliation': 'German International University'}}}}