To Evaluate the Therapeutic Effect of Laser Acupuncture in Patients With Acute or Subacute Post Stroke Shoulder Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Numerical rating scale
研究概览
简要总结
Investigators propose a research design protocol to evaluate the efficacy of laser acupuncture in improving shoulder pain and improving shoulder function recovery after stroke.
详细描述
Shoulder pain after stroke, also known as hemiplegic shoulder pain, is one of the common complications after stroke. The overall incidence rate increases with the time after stroke.The existing treatment methods for shoulder pain after stroke are divided into non-drug and drug. Investigators propose a research design protocol to evaluate the efficacy of laser acupuncture in improving shoulder pain and improving shoulder function recovery after stroke.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Beyond the age of
- •Normal consciousness before and after stroke who can reply and fill in the questionnaire.
- •Subacute (subacute phase: 7 days to 6 months after stroke) and Chronic (chronic phase: more than 6 months after stroke) with shoulder pain after stroke and in post- stroke recovery period.
- •Stop taking painkillers for more than 1 day,
- •Without received intramuscular drugs (steroids, botulinum toxin, glucose, etc.) injections in the shoulder joint or around the shoulder for more than 2 weeks
- •Those willing to sign the written subject consent form.
排除标准
- •Participants with shoulder pain symptoms before the stroke
- •Acute shoulder trauma on the affected side of shoulder pain in the past.
- •Surgery on the affected side of shoulder pain in the past.
- •Those who cannot complete the scale assessment due to aphasia, post-stroke depression, and obvious cognitive impairment.
- •Women who are pregnant or planning to become pregnant.
- •Those who have a history of epilepsy and are receiving anti-epileptic drug treatment.
- •Who are receiving any herbal or folk remedies related to shoulder pain.
- •Any other conditions deemed unsuitable in the assessment of the responsible physician.
- •Those who have not signed the written subject consent form.
研究组 & 干预措施
Intervention group (verum laser acupuncture group )
After blind random allocation, investigators applied verum laser acupuncture on patient with shoulder pain after stroke.
干预措施: Verum laser acupuncture (Device)
Control group (sham laser acupuncture group)
After blind random allocation, investigators applied sham laser acupuncture on patient with shoulder pain after stroke.
干预措施: Sham laser acupuncture (Device)
结局指标
主要结局
Numerical rating scale
时间窗: 3 weeks
Measuring the pain level by Numerical rating scale (scale unit: point). The scales ranged form 1 to 10 and the higher scores mean the worse outcome.
Passive range of motion of shoulder
时间窗: 3 weeks
Measuring the passive range of motion (Scale unit: angular degree) of shoulder (Abduction ranged from 0-180 degree, flexion ranged from 0-180 degree, external rotation ranged from 0-90 degree) of patient with shoulder pain. The higher degree of range of motion mean the better outcome.
次要结局
- Brief Pain Inventory - Short Form (BPI-sf)(3 weeks)
- Meridian energy by Meridian Energy Analysis Devices(3 weeks)
- Visual graphic rating scale (VGRS) of ShoulderQ(3 weeks)