Shoulder Denervation as Management of Post Mastectomy Irradiation Shoulder Pain: Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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)
详细描述
The investigators hypothesize that thermal RF (radiofrequency) of shoulder individual nerves is efficacious for the management of post-mastectomy shoulder pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age (18-65) Years.
- •ASA physical status (II- III).
- •Patients with post mastectomy irradiation shoulder pain.
- •Body mass index (BMI): (20-40) kg/m2.
排除标准
- •Patient refusal.
- •Known sensitivity or contraindication to drugs used in the study.
- •Recent myocardial infarction.
- •Hemodynamically unstable.
- •Local and systemic sepsis.
- •Psychiatric illness.
研究组 & 干预措施
Group 2 (Control): Patients will receive conservative treatment.
Patients will receive conservative treatment Acetaminophen (paracetamol) 1000 mg tid and pregabalin (lyrica)75 mg bid; can be increased, oxycodone (oxynorm) 10mg IR PRN.
干预措施: conservative treatment (Drug)
Group 1 (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder i
Thermal RF therapy will be performed under ultrasound guidance and flouroscopic guidance.
干预措施: (Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF. (Device)
结局指标
主要结局
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.
时间窗: 1 month, 2 months and 3-month intervals following treatment.
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".
次要结局
- Measure oxycodone IR (immediate release) consumption(1 month, 2 months and 3-month intervals following treatment.)
研究者
Suzan Adlan Abdelrahman
Assistant professor
National Cancer Institute, Egypt