Combined Platelet Rich Plasma Intra-articular Shoulder Injection and Stellate Ganglion Block. A New Technique for Management of Chronic Post-mastectomy Shoulder Pain Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Visual analogue score
研究概览
简要总结
Background and Purpose: Adhesive capsulitis of the shoulder is commonly found in patients after breast cancer treatment. We aimed to determine the effectiveness of combined shoulder joint intra-articular injection of platelet rich plasma (PRP) with stellate ganglion block (SGB) with ketamine &bupivacaine injection as a new technique for frozen shoulder (FS) management after mastectomy.
Methods: Sixty four patients with chronic post-mastectomy shoulder pain and stiffness were randomly allocated into one of two groups: group A; ultrasound guided SGB (1 ml ketamine in a dose of 0.5mg/kg plus 5ml bupivacaine 0.5% in total volume 10 ml) and group B; ultrasound guided SGB plus posterior approach shoulder injection with PRP. Visual analogue score (VAS) at rest and at shoulder movement, range of motions (ROM) of shoulder and disability of arm, shoulder and hand (DASH) questionnaire were recorded.
详细描述
Introduction:
Pain after breast surgery is a significant complication and can persist for several months up to years.The most common sites for pain localization are the axilla, medial upper arm and or lateral / anterior chest wall. Pain can be severe enough to cause long-term disabilities leading to shoulder adhesive capsulitis (frozen shoulder) or complex regional pain syndrome. Of course, this could also interfere with daily activities and sleep leading to negative influence on the quality of life of the affected women. Scar formation, protective posture and tension of the soft tissue after surgery can also cause alteration of the shoulder girdle alignment and immobility.
Adhesive capsulitis of the shoulder is commonly found in breast cancer patients with a prevalence can be as high as 86%.Adhesive capsulitis of the shoulder joint is one of the main producers of Post-mastectomy chronic shoulder pain syndrome , the shoulder joint becomes tight due to capsular inflammation resulting in painful and global ROM restriction. Frozen shoulder management has focused around prolonged courses of physiotherapy to maintain shoulder mobility. Corticosteroids and anti-inflammatory medications are also considered as adjuvant therapies in reducing pain and inflammation.
The stellate ganglion is a nerve bundle related to the sympathetic nervous system providing sensation to the upper body. It is present on either side of the trachea at the 7th cervical vertebrae. The stellate ganglion has second and third order neurons that modulate neuropathic pain to the central nervous system and body temperature. The stellate ganglion block (SGB) is mainly indicated for management of chronic neuropathic painful disorders of the head and neck, upper limb, and upper chest by reducing levels of nerve growth factor leading to a decrease in norepinephrine level that plays a fundamental role in pain transmission in these cases. Ketamine enhances the effect of sympathetic blockade with relief of pain, ischaemia and maintains circulation. And so, ketamine is a useful adjuvant to STGB and it clarify the need of permanent destruction of the ganglion by chemical/ radiofrequency neurolysis in patients with peripheral vascular disease.
Recently, platelet-rich plasma (PRP) have been used in treatment of many soft tissue disorders with positive results being rich in several growth factors and other cytokines that can stimulate healing of soft tissues and joints.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Investigators were not allowed to know randomization codes and block size until all calculations and measurements had been entered into the database for all patients. All medical caregivers, investigators and patients were blinded to group allocation. One hour before the injection procedure of an enrolled patient, a nurse (not otherwise participating in the study) opened a sealed opaque envelope containing group allocation, and then filled the assigned drug injection for each patient according to the protocol of randomization.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •post-mastectomy shoulder pain
- •age of 18 to less than 65 years
排除标准
- •refusal to participate
- •Patients with acute shoulder pain (trauma, acute postsurgical pain)
- •secondary adhesive capsulitis (prior surgery or non-surgically induced states of shoulder affection by adhesive capsulitis)
- •hypersensitivity to amide local anesthetics
- •general contraindications to SGB and cardiac and hepatic, renal or respiratory failure.
研究组 & 干预措施
Group A
patients were subjected to ultrasound guided SGB using 1 ml ketamine in a dose of 0.5mg/kg plus 5ml bupivacaine 0.5% in total volume 10 ml
干预措施: ketamine and bupivacaine injection (Drug)
Group B
patients were subjected to ultrasound guided SGB using 1 ml ketamine in a dose of 0.5mg/kg plus 5ml bupivacaine 0.5% in total volume 10 ml plus posterior approach shoulder injection with PRP.
干预措施: Platelet rich plasma (Combination Product)
Group B
patients were subjected to ultrasound guided SGB using 1 ml ketamine in a dose of 0.5mg/kg plus 5ml bupivacaine 0.5% in total volume 10 ml plus posterior approach shoulder injection with PRP.
干预措施: ketamine and bupivacaine injection (Drug)
结局指标
主要结局
Visual analogue score
时间窗: Before injection and 1, 2, 3 months after injection
Visual analogue score (VAS) was done at rest and at shoulder movement before injection, one, two and three months after injection. VAS was explained to the patients during assessment as 0 equal no pain and 10 equal worst imaginable pain. Shoulder mobility was assessed while the patient was sitting using goniometry.
次要结局
- Disability of arm(Before injection and 1, 2 , 3 months after injection)
- Range of motion(Before injection and one month after injection)
研究者
Nevert Adel
Principal investigator
Mansoura University