Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT07095569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-31
First Post:
2025-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shoulder Denervation for Post Mastectomy Irradiation Shoulder Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the changes in NPRS (numerical pain rating scale) for assessment of pain relief which will be recorded before treatment and at 1 month, 2 months and 3-month intervals following treatment.', 'timeFrame': '1 month, 2 months and 3-month intervals following treatment.', 'description': 'numerical pain rating scale is a measurement tool that uses numbers to represent the intensity of a characteristic or quality, where 0 might represent "no pain" and 100 the highest number represents "the worst pain imaginable".'}], 'secondaryOutcomes': [{'measure': 'Measure oxycodone IR (immediate release) consumption', 'timeFrame': '1 month, 2 months and 3-month intervals following treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Breast cancer is the second most common cancer world-wide following lung cancer. It afflicts about 1.7 million patients annually, of which 60% mandate surgery of the breast and/or the axilla, and nearly 20-50% of them may develop post mastectomy pain syndrome .\n\nAfter breast cancer surgery, between 6% and 86% of people may develop tight bands of fibrous tissue under their skin, known as axillary web syndrome. These bands can cause pain in the shoulder area by trying to raise or extend the arm. Shoulder pain is a common side effect of breast cancer surgery and treatment.\n\nVarious medical and interventional procedures have been tried for treating postmastectomy shoulder pain, with varying efficacy . Among the interventional procedures that may have a role for treatment.\n\nInnervation of the glenohumeral joint (GHJ) can be divided into anterior and posterior innervation from articular branches of the suprascapular nerve (SN):C5 \\&6 (posterior-lateral), axillary nerve (AN):C5 \\&6 (anterior-lateral, inferior, and posteriorlateral), and lateral pectoral nerve (LPN): C5 \\&6 (anterior superior)', 'detailedDescription': 'The investigators hypothesize that thermal RF (radiofrequency) of shoulder individual nerves is efficacious for the management of post-mastectomy shoulder pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age (18-65) Years.\n2. ASA physical status (II- III).\n3. Patients with post mastectomy irradiation shoulder pain.\n4. Body mass index (BMI): (20-40) kg/m2.\n\nExclusion Criteria:\n\n1. Patient refusal.\n2. Known sensitivity or contraindication to drugs used in the study.\n3. Pregnancy.\n4. Recent myocardial infarction.\n5. Hemodynamically unstable.\n6. Local and systemic sepsis.\n7. Psychiatric illness.'}, 'identificationModule': {'nctId': 'NCT07095569', 'briefTitle': 'Shoulder Denervation for Post Mastectomy Irradiation Shoulder Pain', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Shoulder Denervation as Management of Post Mastectomy Irradiation Shoulder Pain: Randomized Control Trial', 'orgStudyIdInfo': {'id': 'IORG003381'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder i', 'description': 'Thermal RF therapy will be performed under ultrasound guidance.', 'interventionNames': ['Device: (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 (Control): Patients will receive conservative treatment.', 'description': 'Patients will receive conservative treatment Acetaminophen (paracetamol) 1000 mg tid and pregabalin (lyrica)75 mg bid; can be increased to 150 mg bid, oxycodone (oxynorm) 10mg IR PRN.', 'interventionNames': ['Drug: conservative treatment']}], 'interventions': [{'name': '(Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF.', 'type': 'DEVICE', 'description': 'Shoulder individual nerves thermal RF technique: The patient will be put in the sitting position, monitored with electrocardiography, pulse oximetry, and non-invasive blood pressure. after disinfection A high-frequency linear transducer (10-15 Hz) will be placed parallel and cephalad to the spine of the scapula. The probe will be moved from cephalad to caudad until the trapezius and supraspinatus muscles were identified. The suprascapular nerve will be identified as a hyperechogenic structure in the suprascapular fossa deep to the superior transverse scapular ligament. A 10 cm radiofrequency needle, with a 10 mm active tip, will be inserted in plane with the ultrasound beam and advanced to reach the proximity to the nerve. A nerve stimulator was used as an additional nerve-finding modality.', 'armGroupLabels': ['Group 1 (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder i']}, {'name': 'conservative treatment', 'type': 'DRUG', 'description': 'Patients will receive conservative treatment Acetaminophen (paracetamol 1000 mg tid and pregabalin (lyrica) 75 mg bid; can be increased to 150 mg bid, oxycodone (oxynorm) 10mg IR PRN.', 'armGroupLabels': ['Group 2 (Control): Patients will receive conservative treatment.']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'suzan Adlan', 'role': 'CONTACT', 'email': 'dr_s.adlan@hotmail.com', 'phone': '+201111068300'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Suzan Adlan Abdelrahman', 'investigatorAffiliation': 'National Cancer Institute, Egypt'}}}}