NCT07095569

Shoulder Denervation for Post Mastectomy Irradiation Shoulder Pain

Shoulder Denervation as Management of Post Mastectomy Irradiation Shoulder Pain: Randomized Control Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Cancer Institute, Egypt · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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 . After 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. Various 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. Innervation 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)

Detailed description

The investigators hypothesize that thermal RF (radiofrequency) of shoulder individual nerves is efficacious for the management of post-mastectomy shoulder pain.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	(Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF.	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.
DRUG	conservative treatment	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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-08-01
• Completion: 2026-08-30
• First posted: 2025-07-31
• Last updated: 2025-07-31