Changes in Clinical Outcomes After Application of Physical Therapy and Dry Needling Intervention in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Changes in spasticity before and after the intervention
研究概览
简要总结
The investigators aim to determine if dry needling technique in a non myofascial trigger point area generate the same changes in spasticity, function and pain responses as with dry needling in a myofascial trigger point area.
详细描述
Spasticity is a consequence of multiple diseases that affect the Central Nervous System, such as stroke and other neurodegenerative diseases. Its pathophysiology is unclear and the variety of clinical symptoms is determined by the injury location. Several studies have suggested the possibility of active pain treatment effectiveness through myofascial trigger points management. One of these interventions is dry needling, which has been used in several scientific studies. However, these investigations have been based on spasm response or deep dry needling mechanisms always over a trigger point, but none of the participants compare the possible mechanical effects of the insertion of a needle into a spastic muscle without targeting specifically a trigger point. Therefore, the aim of this study is to evaluate the effects on spasticity, pain and motor function after a dry needling intervention versus the insertion of a needle into a non trigger point area in patients who had experienced a stroke.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical diagnosis of unilateral ischemic Stroke
- •Unilateral hemiplegia resulting from Stroke
- •Evolution of at least 6 months since the Stroke
- •Age between 35 and 81 years of age
- •Presence of hypertonia in the upper extremity
- •Restricted shoulder range of motion
排除标准
- •Recurrent Stroke
- •Previous treatment with nerve blocks, motor point injections with neurolytic agents for Spasticity at any time, or with BTX-A in the previous 6 months
- •Cognitive deficits
- •Progressive or severe neurological diseases, eg, heart conditions, unstable hypertension, fractures or implants in upper extremity
- •Belonephobia (fear to needles)
- •Have received pharmacological treatment for shoulder pain 3 months before the study
- •Existence of peripheral nerve injury
- •Previous history of fracture in the gleno-humeral joint
- •Episodes of epilepsy in the year prior to participation in the study
结局指标
主要结局
Changes in spasticity before and after the intervention
时间窗: Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention
It will be measured using the Modified Ashworth Scale. The Modified Ashworth Scale evaluates the muscle tone in patients with central nervous system lesions. It consists of 5 ordinal categories: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder less than half of the range of motion), 2 (more marked increase in muscle tone through most of the range of motion, but affected parts easily moved), 3 (considerable increase in muscle tone, passive movement difficult) and 4 (the part affects this rigid extension or flexion).
次要结局
- Changes in shoulder pain before and after the intervention(Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention)
- Changes in Function of the Upper Extremity before and after the intervention(Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention)
研究者
Alma Rocío Hernández Ortíz
Principal Investigator
Universidad Rey Juan Carlos