Changes in Spasticity, Range of Motion and Pressure Pain Sensitivity in Patients With Stroke After the Application of Dry Needling in the Shoulder Musculature
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Changes in spasticity before and after the intervention
研究概览
简要总结
Stroke is the leading cause of physical disability due to the presence of spasticity. Different needling techniques, including Botulinum Toxin A are proposed for management of spasticity; however results are conflicting. The presence of spasticity in the upper extremity implies several impairments for daily life activities. No study has investigated the effects of deep dry needling inserted into the targeted spastic musculature of the shoulder region in patients who had suffered a stroke. The investigators will conduct a randomized controlled trial investigating the effects of the inclusion of deep dry needling into a rehabilitation program over the musculature of the shoulder region, pressure pain hyperalgesia and range of motion in individuals with chronic stroke. The investigators hypothesize that patients receiving dry needling into the spastic shoulder musculature would exhibit greater improvements in spasticity, pressure sensitivity and range of motion than those who will not receive the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first-ever unilateral stroke;
- •hemiplegia resulting from stroke;
- •age between 40 and 65 years old;
- •presence of hypertonicity in the upper extremity;
- •restricted range of motion of the shoulder
排除标准
- •recurrent stroke;
- •previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time;
- •previous treatment with BTX-A in the 6 months prior the study;
- •severe cognitive deficits; 5, progressive or severe neurologic diseases, e.g., heart conditions, unstable hypertension, fracture or implants in the lower extremity;
- •fear to needles;
- •any contraindication for deep dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.
结局指标
主要结局
Changes in spasticity before and after the intervention
时间窗: Baseline and immediate after the interventionBaseline (1 week before) and 1 week after intervention
Spasticity in the affected ankle joint will be evaluated with the Modified Modified Ashworth Scale (MMAS). The examiner passively moved the upper extremity in a stretching direction of each muscle (shoulder depression, shoulder external rotation, shoulder internal rotation, and shoulder abduction 90º combined with external rotation, respectively), back and forth at least 5 times and evaluated the degree of resistance to the movement on a scale from 0-4
次要结局
- Changes in shoulder mobility before and after the intervention(Baseline (1 week before) and 1 week after intervention)
- Changes in pressure pain sensitivity before and after the intervention(Baseline (1 week before) and 1 week after intervention)
研究者
César Fernández-de-las-Peñas
Proffesor
Universidad Rey Juan Carlos