Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-26 @ 7:16 AM
Study NCT ID:
NCT06248866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect Of Extracorporeal Shock Wave Therapy On Ultrasonography Changes In Patients With Palmar Fibromatosis: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004387', 'term': 'Dupuytren Contracture'}], 'ancestors': [{'id': 'D005350', 'term': 'Fibroma'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003286', 'term': 'Contracture'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, '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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'opaque sealed envelope'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'extracorporeal shock wave therapy and traditional treatment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2024-01-31', 'studyFirstSubmitQcDate': '2024-01-31', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'thickness of lesion', 'timeFrame': 'up to six weeks', 'description': 'Ultrasonography will be used to assess the thickness of lesion'}], 'secondaryOutcomes': [{'measure': 'Disabilities of the Arm, Shoulder, and Hand', 'timeFrame': 'up to six weeks', 'description': 'The Arabic version of the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire will be administered to evaluate functional outcomes.The questionnaire consists of 11 items related to daily activities and symptoms. Each item is rated on a 5-point Likert scale, with higher scores indicating greater disability'}, {'measure': 'pressure pain threshold', 'timeFrame': 'up to six weeks', 'description': 'algometer will be used to assess pressure pain threshold'}, {'measure': 'hand grip strength', 'timeFrame': 'up to six weeks', 'description': 'Jamar hand held dynamometer will be used to assess hand grip strength'}, {'measure': 'finger range of motion', 'timeFrame': 'up to six weeks', 'description': 'goniometer will be used to assess finger range of motion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extracorporeal Shock Wave Therapy', 'Ultrasonography Changes', 'Palmar Fibromatosis'], 'conditions': ['Palmar Fibromatosis']}, 'descriptionModule': {'briefSummary': 'this study will be conducted to investigate the effect of extracorporeal shock wave therapy on ultrasonography chnges In patients with palmar fibromatosis', 'detailedDescription': "Palmar fibromatosis, also known as Dupuytren's contracture, is a condition that affects the hand and fingers. It is characterized by the thickening and tightening of the fascia, a layer of connective tissue beneath the skin of the palm. This thickening and tightening can lead to the formation of nodules or cords that restrict the movement of the affected fingers. The treatment options for palmar fibromatosis vary depending on the severity of the condition and its impact on hand function. Mild cases may not require immediate treatment but should be regularly monitored. However, if the symptoms worsen or hinder hand function, there are several treatment options available. Extracorporeal shock wave therapy (ESWT) is a non-invasive physical therapy procedure that uses high-energy sound waves to treat various musculoskeletal conditions. It is commonly used to manage pain and promote healing in conditions such as plantar fasciitis, tendinitis, calcific tendinitis, and other similar disorders The ESWT has shown promising results in reducing pain, improving function, and promoting healing in various musculoskeletal conditions. sixty patients with palmar fibromatosis will be assigned randomly to two groups; first one will receive extracorporeal shock wave with traditional therapy and the other one will receive traditional therapy only"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with palmar fibromatosis.\n* Adults aged 18 to 70 years.\n* Patients of any stage of physiological change of the disease (nodules cords and contractures).\n\nExclusion Criteria:\n\n* Patients with contraindications to extracorporeal shock wave therapy.\n* Patients with a history of previous surgery for palmar fibromatosis.\n* Patients with comorbidities or conditions that may affect the outcomes of the study.\n* Patients of ganglions and palmar tendon fibrosis.\n* Patients of sever and morbid obesity.\n* End stage disease with psychological disturbance nature.\n* Pregnant women.\n* Cardiac and pulmonary unstable patients may affect results.'}, 'identificationModule': {'nctId': 'NCT06248866', 'acronym': 'ESWT', 'briefTitle': 'Effect Of Extracorporeal Shock Wave Therapy On Ultrasonography Changes In Patients With Palmar Fibromatosis: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect Of Extracorporeal Shock Wave Therapy On Ultrasonography Changes In Patients With Palmar Fibromatosis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004965'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extracorporeal Shock Wave Therapy', 'description': 'patients will receive Extracorporeal Shock Wave Therapy and traditional treatment three times a week for six weeks', 'interventionNames': ['Other: Extracorporeal Shock Wave Therapy', 'Other: traditional treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'traditional treatment', 'description': 'patients will receive traditional treatment three times a week for six weeks', 'interventionNames': ['Other: traditional treatment']}], 'interventions': [{'name': 'Extracorporeal Shock Wave Therapy', 'type': 'OTHER', 'description': 'The affected hand or fingers will be positioned comfortably to ensure optimal access to the fibromatosis lesion. Gel or oil will be applied to the skin to enhance the transmission of shock waves. Shock wave therapy will be administered using the selected energy level and frequency settings. Energy level and frequency will be customized based on individual patient requirements. (1000-1500 shock/session, frequency between 5-12HZ, compression power of 1.5- 2.5 bars).and will receive traditional treatment', 'armGroupLabels': ['Extracorporeal Shock Wave Therapy']}, {'name': 'traditional treatment', 'type': 'OTHER', 'description': 'the patients will receive traditional treatment in the form of laser (A low-level laser device with a wavelength of 830 nm and power output of 50 mW will be used as one Of the pain relief methods), ultrasound (An ultrasound device with a frequency of 1 MHz and an intensity of 1.5 W/cm² will be used), stretching and strengthening exercise and splinting.', 'armGroupLabels': ['Extracorporeal Shock Wave Therapy', 'traditional treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'nabil abdel-aal, professor', 'role': 'CONTACT', 'email': 'nabil.mahmoud@cu.edu.eg', 'phone': '01080619880'}, {'name': 'mohamed soliman, spescialist', 'role': 'CONTACT', 'email': 'abosma3il@yahoo.com', 'phone': '01111505351'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator nabil mahmoud ismail abdel-aal', 'investigatorFullName': 'Nabil Mahmoud Ismail Abdel-Aal', 'investigatorAffiliation': 'Cairo University'}}}}