Shoulder Denervation for Post Mastectomy Irradiation Shoulder Pain

National Cancer Institute, Egypt

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Drug: conservative treatment; Device: (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF.

Study type: Interventional

Funder types: Other

Identifiers

NCT07095569

IORG003381

Details and patient eligibility

About

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)

Full description

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age (18-65) Years.
2. ASA physical status (II- III).
3. Patients with post mastectomy irradiation shoulder pain.
4. Body mass index (BMI): (20-40) kg/m2.

Exclusion criteria

1. Patient refusal.
2. Known sensitivity or contraindication to drugs used in the study.
3. Pregnancy.
4. Recent myocardial infarction.
5. Hemodynamically unstable.
6. Local and systemic sepsis.
7. Psychiatric illness.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Group 1 (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder i

Experimental group

Description:

Thermal RF therapy will be performed under ultrasound guidance.

Treatment:

Device: (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF.

Group 2 (Control): Patients will receive conservative treatment.

Active Comparator group

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.

Treatment:

Drug: conservative treatment