Comparison of the Effects of Ultrasound-guided Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from Baseline in Visual Analog Scale (VAS) score
研究概览
简要总结
Hemiplegic shoulder pain is the most common poststroke painful condition. Hemiplegic shoulder pain reduces range of motion (ROM) and hand function, resulting in limited daily life activity and decreased quality of life.
In the literature, the effectiveness of suprascapular nerve block and subacromial injection in hemiplegia patients with shoulder pain has been previously evaluated, but these injection treatments have not been compared.
Therefore, the aim of this study is to compare the effectiveness of suprascapular nerve block and subacromial injection on pain, shoulder (ROM), function and quality of life in hemiplegia patients with shoulder pain.
详细描述
Patients will be randomly assigned Subacromial injection group or Suprascapular nerve block group
In the suprascapular nerve block group, suprascapular nerve block will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the suprascapular fossa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 22 gauge 90-mm injector.
In the subacromial injection group, subacromial injection will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the subacromial bursa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 21 gauge 38-mm injector.
A home exercise program will be given both groups. The exercise program consisted of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Brunstrom stage 2 to 5
- •spasticity <4 according to the modified Ashworth scale
- •having hemiplegia less than 12 months
- •Presence of shoulder pain lasting more than 3 months
- •Conservative treatment for painful shoulder before injection
排除标准
- •Patients over 75 years old, under 30 years old
- •Anti-coagulant or antiaggregant use
- •Presence of diabetes mellitus
- •Patients who could not be cooperated and Mini-mental Test (MMSE) score <24
- •Having previously had suprascapular block or subacromial injection
- •Presence of complex regional pain syndrome (type I),
- •The presence of neglect syndrome
结局指标
主要结局
Change from Baseline in Visual Analog Scale (VAS) score
时间窗: baseline, month 1 and month 3
Self-reported neck pain intensity will be evaluated with the Visual Analog Scale (VAS). Patients will be asked about the average pain intensity that they had felt in the past week ("0" defines "no pain" and "10" defines "unbearable pain'').
次要结局
- Shoulder ROM(baseline, month 1 and month 3)
- Functional Independence Measure (FIM)(baseline, month 1 and month 3)
- EuroQol 5D-3L questionnaire (EQ-5D-3L)(baseline, month 1 and month 3)
研究者
Mustafa Corum
Principal Investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital