Shoulder Denervation for Post Mastectomy Irradiation Shoulder Pain

Официальное название

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

Обзор

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)

Подробное описание

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

Вмешательства

• Устройство (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
• Препарат 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.

Первичные конечные точки

• 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. [Срок оценки: 1 month, 2 months and 3-month intervals following treatment.]

Вторичные конечные точки (1)

• Measure oxycodone IR (immediate release) consumption [Срок оценки: 1 month, 2 months and 3-month intervals following treatment.]

Критерии участия

Критерии включения

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

Критерии исключения

• Patient refusal.
• Known sensitivity or contraindication to drugs used in the study.
• Pregnancy.
• Recent myocardial infarction.
• Hemodynamically unstable.
• Local and systemic sepsis.
• Psychiatric illness.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• National Cancer institute — Cairo

Идентификаторы

NCT: NCT07095569 · IORG003381

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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