Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 1:13 AM
Study NCT ID:
NCT07440550
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Extracorporeal Shockwave Therapy on Painful Bone Spur in Traumatic Transfemoral Amputees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054850', 'term': 'Osteophyte'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D005096', 'term': 'Exostoses'}, {'id': 'D015576', 'term': 'Hyperostosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}, {'id': 'D005081', 'term': 'Exercise 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'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'At baseline, 4 weeks post-application, and 12 weeks post-application', 'description': 'Visual Analog Scale at rest and during walking with the prosthesis. It is a 10 cm scale, that 0 demostrates no pain and 10 indicates the most unbearable pain'}], 'secondaryOutcomes': [{'measure': 'Lower Extremity Functional Scale', 'timeFrame': 'At baseline, 4 weeks post-application, and 12 weeks post-application', 'description': 'The scale can be scored from 0 to 80 points. Higher scores indicate better functionality.'}, {'measure': 'Houghton Scale', 'timeFrame': 'At baseline, 4 weeks post-application, and 12 weeks post-application', 'description': 'The total score ranges from a minimum of 0 to a maximum of 12; higher scores indicate better performance and comfort.'}, {'measure': 'Locomotor Capacity Index', 'timeFrame': 'At baseline, 4 weeks post-application, and 12 weeks post-application', 'description': 'The maximum score is 42, and locomotor ability increases as the total score increases.'}, {'measure': 'Radiologically determined size of bone spur', 'timeFrame': 'At baseline, 4 weeks post-application, and 12 weeks post-application', 'description': 'Anterior-posterior/lateral X-ray images of the remaining femur are taken, and the size of the bony prominence is measured in millimeters.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amputation', 'Bone spur', 'Extracorporeal Shockwave Therapy', 'Pain'], 'conditions': ['Traumatic Transfemoral Amputation', 'Painful Bone Spur']}, 'descriptionModule': {'briefSummary': 'Painful bone spur is one of the causes of residual limb pain in individuals with traumatic lower extremity amputation and can be a significant problem in rehabilitation clinics. This study aimed to investigate the effectiveness of extracorporeal shockwave therapy (ESWT) on pain and size of bone spur in traumatic transfemoral amputees with painful bone spur. Twenty nine traumatic transfemoral amputees who had painful spur were randomized into two groups: Group 1 (ESWT + therapeutic exercise) and Group 2 (sham ESWT + therapeutic exercise). The visual analog scale for pain felt in the stump at rest and during walking with the prosthesis, the lower extremity functional scale, Houghton scale, Locomotor capacity index, and radiologically determined bone spur size were used as outcome measures. All participants were evaluated before, 4 weeks after, and 12 weeks after ESWT/sham ESWT application.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Erkek', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria for the current study :\n\n* unilateral transfemoral amputation due to trauma for at least 6 months\n* male aged between 18 and 65\n* pain in the stump region of 3 or more on the visual analog scale (VAS) for at least 1 month\n* bone spur in the stump diagnosed by radiography\n* failure to provide sufficient benefit from previous conservative treatment (lack of at least 50% pain reduction with analgesics and nonsteroidal anti-inflammatory drugs)\n* failure to provide adequate response to socket revision\n\nExclusion Criteria:\n\n* infection, cellulite, neuroma, fracture, skin problems that may cause pain in the stump other than bone spur\n* corticosteroid injection or surgery to the stump in the last 6 months\n* conditions in which the use of ESWT is contraindicated, such as bone tumors, metabolic bone problems, nerve conduction and blood circulation disorders'}, 'identificationModule': {'nctId': 'NCT07440550', 'briefTitle': 'Efficacy of Extracorporeal Shockwave Therapy on Painful Bone Spur in Traumatic Transfemoral Amputees', 'organization': {'class': 'OTHER', 'fullName': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital'}, 'officialTitle': 'Efficacy of Extracorporeal Shockwave Therapy on Painful Bone Spur in Traumatic Transfemoral Amputees: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'E-68869993-000-1309046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ESWT + therapeutic exercise', 'interventionNames': ['Device: Extracorporeal shockwave therapy (ESWT)', 'Other: Therapeutic exercise']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham ESWT + therapeutic exercise', 'interventionNames': ['Other: Therapeutic exercise', 'Device: sham ESWT']}], 'interventions': [{'name': 'Extracorporeal shockwave therapy (ESWT)', 'type': 'DEVICE', 'description': 'Participants in Group 1 received a total of four sessions of ESWT, once a week for four consecutive weeks, with an intensity of 0.3 mj/mm2, a frequency of 4 Hz, and 1500 pulses/session', 'armGroupLabels': ['ESWT + therapeutic exercise']}, {'name': 'Therapeutic exercise', 'type': 'OTHER', 'description': 'Balance-coordination and endurance-enhancing exercises, range of motion exercises, isometric and isotonic strengthening exercises were applied to patients in both groups five days a week for four weeks', 'armGroupLabels': ['ESWT + therapeutic exercise', 'sham ESWT + therapeutic exercise']}, {'name': 'sham ESWT', 'type': 'DEVICE', 'description': 'Participants in Group 2 received a total of four sessions of sham ESWT, once a week for four consecutive weeks, with an intensity of 0 mj/mm2, a frequency of 4 Hz, and 1500 pulses/session', 'armGroupLabels': ['sham ESWT + therapeutic exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'Turkey', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziler Physical Therapy and Rehabilitation Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There should be a commitment that patient data will only be shared with the ethics committee upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nurdan Korkmaz', 'investigatorAffiliation': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital'}}}}