Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-02 @ 2:26 AM
Study NCT ID:
NCT07102992
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Burn Cubital Tunnel Syndrome Response to High Intensity Laser Therapy Versus Shock Wave Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a parallel group randomized controlled trial with 3 arms receiving different interventions.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-09', 'studyFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nerve Conduction Studies of ulnar nerve', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Nerve conduction studies will assess the function/integrity of the ulnar nerve. Patients will be evaluated at base line before treatment and after completion of treatment using Neuropack S1MEB-9004 NIHON KODEN, JAPAN for measuring the motor conduction velocity of the ulnar nerve.'}], 'secondaryOutcomes': [{'measure': 'The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire', 'timeFrame': 'Baseline and 4 weeks', 'description': 'The DASH questionnaire consists of 30 questions regarding limitations to complete physical activities due to upper extremity pain/impairment. Participants will be asked to respond to each question based on their experiences over the preceding week according to a 5-point Likert scale ranging from\n\n1 (no difficulty) to 5 (unable to do). Responses will be scored out of 5 and averaged to produce a score out of 100 with higher scores representing greater disability.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Burn Cubital Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'Significant morbidity in burn patients occurs frequently because of Post burn nerve entrapment syndromes. Nerve entrapment arises due to direct compression because of edema; they may also present due to scar tissue formation.\n\nBurns of the forearm and elbow are associated with swelling, redness and pain. In second to third-degree burns, the eschar forms a tight band constricting the circulation distally and forms edema that leads to compression neuropathy of ulnar nerve. Also the hyper metabolic response of the burned patients, has been suggested as a cause of the peripheral neuropathies, as the basal metabolic rate (B.M.R) of the burned patients increase more than 2 to 2.5 times normal.', 'detailedDescription': 'Significant morbidity in burn patients occurs frequently because of Post burn nerve entrapment syndromes. Nerve entrapment arises due to direct compression because of edema; they may also present due to scar tissue formation.\n\nBurns of the forearm and elbow are associated with swelling, redness and pain. In second to third-degree burns, the eschar forms a tight band constricting the circulation distally and forms edema that leads to compression neuropathy of ulnar nerve. Also the hyper metabolic response of the burned patients, has been suggested as a cause of the peripheral neuropathies, as the basal metabolic rate (B.M.R) of the burned patients increase more than 2 to 2.5 times normal.\n\nCubital tunnel syndrome is the second most common entrapment neuropathy of the upper extremity, after carpal tunnel syndrome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 20-50 years.\n2. Both sexes.\n3. Post healed elbow burn.\n4. Diagnosed with cubital tunnel syndrome.\n5. Willing and able to provide informed consent.\n\nExclusion Criteria:\n\n1. Patients with brachial plexopathy.\n2. C8-T1 radiculopathy, polyneuropathy.\n3. Previous elbow fractures or operation.\n4. Systemic diseases such as diabetes mellitus, malignancy, and active infection.\n5. Patients with any contraindications to high intensity laser therapy or shock wave therapy.'}, 'identificationModule': {'nctId': 'NCT07102992', 'briefTitle': 'Post Burn Cubital Tunnel Syndrome Response to High Intensity Laser Therapy Versus Shock Wave Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Ahram Canadian University'}, 'officialTitle': 'Post Burn Cubital Tunnel Syndrome Response to High Intensity Laser Therapy Versus Shock Wave Therapy', 'orgStudyIdInfo': {'id': 'HILT-SHWT 2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High intensity laser therapy', 'description': 'Device: High intensity laser therapy 25 Patients', 'interventionNames': ['Device: High intensity laser therapy', 'Other: Ulnar nerve gliding exercises.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Shock Wave therapy', 'description': 'Extracorporeal shock wave therapy, 25 patients', 'interventionNames': ['Device: Shock Wave therapy', 'Other: Ulnar nerve gliding exercises.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ulnar nerve gliding exercises.', 'description': 'Ulnar nerve gliding exercises, 25 patients', 'interventionNames': ['Other: Ulnar nerve gliding exercises.']}], 'interventions': [{'name': 'High intensity laser therapy', 'type': 'DEVICE', 'description': 'High intensity Laser Therapy :A standard handpiece endowed with fixed spacers will used to provide the same distance to the skin and perpendicularly to the zone to be treated with a laser beam diameter of 5 mm. Three phases of treatment will be performed for every session. The total energy that will be delivered to the patient during one session will be 1275 J through three phases of treatment.\n\nFrequency of treatment: Treatment will be given 5 times / week for 20 sessions.', 'armGroupLabels': ['High intensity laser therapy']}, {'name': 'Shock Wave therapy', 'type': 'DEVICE', 'description': 'radial extracorporeal shock wave therapy (2,000 shots, 4 Bar, 5 Hz) (once a week) will be administered to the ulnar nerve at the proximal cubital tunnel region.\n\nFrequency of treatment: Treatment will be given 1 time / week for 4 sessions', 'armGroupLabels': ['Shock Wave therapy']}, {'name': 'Ulnar nerve gliding exercises.', 'type': 'OTHER', 'otherNames': ['Ulnar nerve gliding exercises'], 'description': 'While keeping patients head in a neutral position, will teach the patient to:\n\n1. Begin with your arm out, palm side of the hand facing up.\n2. Bend the elbow toward you, palm side facing you.\n3. Rotate the palm of your hand outward and bend your wrist so that the fingers are pointing towards you.\n4. Twist your wrist so that the palm of your hand is now facing upward.\n5. While your wrist remains bent, stretch out your arm into a straight position, with your fingers bent towards the floor.\n\nHold each position for 5 seconds, repeat series 3-5 times. Frequency of treatment: Treatment will be given 5 times / week for 20 sessions.', 'armGroupLabels': ['High intensity laser therapy', 'Shock Wave therapy', 'Ulnar nerve gliding exercises.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banhā', 'state': 'Al Qalyubia', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Out patient clinic , faculty of Physical Therapy, Benha university', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}, {'city': 'Giza', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Out patient clinic , faculty of Physical Therapy, ahram Canadian university', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Mahmoud Mohamed, Ph.D', 'role': 'CONTACT', 'email': 'mahmoud.mohamed@fpt.bu.edu.eg', 'phone': '01111750888'}, {'name': 'Waleed Mansour, Ph.D', 'role': 'CONTACT', 'phone': '01005311168'}], 'overallOfficials': [{'name': 'Waleed Mansour, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Physical Therapy, Benha university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahram Canadian University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Benha University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mahmoud H Mohamed, PhD', 'investigatorAffiliation': 'Ahram Canadian University'}}}}