Effectiveness and Safety of Electroacupuncture for Poststroke Patients With Shoulder Pain: Study Protocol for a Multicenter, Randomized, Patient and Assessor Blinded, Sham Controlled, Parallel, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Mean difference of visual analogue scale (VAS) between baseline and endpoint
研究概览
简要总结
This is a multicenter, randomized, sham-controlled, patient- and assessor-blinded, and parallel trial to explore the effectiveness and safety of electroacupuncture (EA) therapy, compared with sham EA, for poststroke shoulder pain.
详细描述
This study is aimed at showing the effectiveness and safety of electroacupuncture therapy for the stroke survivors with shoulder pain. 60 stroke survivors with shoulder pain will be enrolled in two traditional Korean medicine hospitals and randomly divided into either of verum or sham electroacupuncture group with 1:1 of allocation ratio. The participants will receive 9 sessions of electroacupuncture procedures for 3 weeks. Patients and outcome assessors will be blinded from the beginning to the study completion. Visual analogue scale will be primarily evaluated, and pain rating scale, Fugl-Meyer assessment upper extremity, modified Ashworth scale, manual muscle test, passive range of motion, Korean version of modified Barthel index, and Korean version of Beck depression inventory will be measured, too. Blinding index will be assessed. For safety, adverse events will be collected.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with cerebral hemorrhage or infarction examined by computed tomography (CT) magnetic resonance imaging (MRI) at least 2 weeks or more ago;
- •complaining hemiplegic shoulder pain of VAS ≥4;
- •agreeing that any treatments, including analgesics, for hemiplegic shoulder pain will not be changed from the previous 2 weeks prior to the enrollment until the last evaluation, if applicable;
- •fully explained about the clinical research and sign the informed consents.
排除标准
- •disorders, traumatic injury, or surgery of shoulders even before their stroke;
- •pacemakers, embedded neural stimulator, cardiac arrhythmia, epilepsy, peripheral neural injury on their medical history;
- •psychiatric disorders;
- •cancer within the past 5 years, regardless of its prognosis and location;
- •cognitive impairment that interferes with clinical assessment;
- •hypersensitivity or fears to acupuncture;
- •bleeding disorders (e.g. hemophilia or von Willebrand disease, etc.),
- •pregnancy,
- •difficulty in communicating with researchers, or
- •any other conditions who are considered inappropriate for participating in the trial by experienced practitioners.
研究组 & 干预措施
verum electroacupuncture
- Electroacupuncture on LI4, LI15, TE14, SI9, SI11, and GB21, unilaterally
- Needle insertion by 10-15 mm and de qi sensation
- Park sham guide tubes
- Low frequency electronic stimulation (30 Hz)
- Retention for 20 minutes.
干预措施: electroacupuncture (Device)
sham electroacupuncture
- Park sham device on on LI4, LI15, TE14, SI9, SI11, and GB21, unilaterally
- Needle installation without penetration
- Park sham guide tubes
- Low frequency electronic stimulation (30 Hz) for a fake noise without conduction
- Retention for 20 minutes.
干预措施: sham electroacupuncture (Device)
结局指标
主要结局
Mean difference of visual analogue scale (VAS) between baseline and endpoint
时间窗: 3 weeks
VAS is a patient-rated outcome with a 10-cm line representing 'not painful at all' for zero and 'most painful' for ten. Patient marks x on the line by oneself, based on how intense he/she thinks the pain is and assessor measures the length from zero point to x mark, which is the pain score.
次要结局
- before-after change of visual analogue scale (VAS) (intragroup effect)(1~3 weeks)
- Mean difference of pain rating scale (PRS) between baseline and endpoint(3 weeks)
- Mean difference of Fugl-Meyer assessment - upper extremity (FMA-UE) between baseline and endpoint(3 weeks)
- Mean difference of passive ranges of motion (PROM) between baseline and endpoint(3 weeks)
- Mean difference of manual muscle test (MMT) between baseline and endpoint(3 weeks)
- Mean difference of modified Ashworth scale (MAS) between baseline and endpoint(3 weeks)
- Mean difference of Korean version of modified Barthel index (K-MBI) between baseline and endpoint(3 weeks)
- Mean difference of Korean version of Beck depression inventory (K-BDI) between baseline and endpoint(3 weeks)
- mean difference of the occurrence numbers of adverse events(3 times per week, 3 weeks, through study completion,)
研究者
Lee Eui-ju
Professor, Ph.D. KMD.
Kyunghee University