A Randomized Controlled Trial to Evaluate a Comprehensive Protocol With Four Therapeutic Modalities for the Treatment of Upper Limb Spasticity in Post-stroke Hemiplegic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Quality of Life - SF-36 questionnaire
研究概览
简要总结
The general objective of this study was to evaluate the efficacy of the comprehensive protocol in improving post-stroke upper limb spasticity. The specific objectives were to evaluate pain improvement and changes in quality of life and functional capacity in patients who were subjected to the comprehensive protocol compared with those in the patients who underwent sham interventions.
详细描述
Background: Managing post-stroke upper limb spasticity is a major challenge in the rehabilitation field. The objective of this study was to evaluate the efficacy of a comprehensive treatment protocol with four therapeutic modalities in the recovery of patients with chronic stroke by evaluating clinical, neurological and functional outcomes.
Methodology: Thirty-two subjects diagnosed with a stroke at least six months prior to the study were randomized to receive ten sessions of either the treatment protocol or a sham intervention. The treatment protocol consisted of transcranial low-frequency electrical stimulation using subcutaneous needles over the scalp, paraspinous blocks, spastic muscle needling and functional electrical stimulation. Spasticity, range of motion, pain, functionality and quality of life were evaluated.
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)
盲法说明
The Sham Group received the four modalities of the intervention, but these modalities were all inactive. For simulation of transcranial electrical stimulation and FES, electrodes were placed on the scalp and in the upper extremity muscles and were connected to a device similar to the real electric current generator. This device did not transmit any electric current but had blinking lights and produced sound to provide the subjects visual and auditory feedback. To simulate dry needling and paraspinous block, retractile needles were used. The patients were blinded to their assigned treatment group. Blinded examiners evaluated patients at baseline, one week post-treatment and three months post-treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 18 years;
- •Diagnosis of ischemic or hemorrhagic stroke at least six months previously;
- •Presence of single upper limb spasticity
排除标准
- •Spasticity due to conditions other than stroke;
- •Hypersensitivity to lidocaine;
- •Use of cardiac pacemakers;
- •Presence of coagulation disturbances;
- •Insufficient perceptual and cognitive capacity to understand the proposed treatment and answer the questionnaires
研究组 & 干预措施
Protocol Group (PG)
The PG received the following combination of four therapeutic modalities twice a week for five weeks:
- Low-frequency transcranial electrical stimulation;
- Paraspinous block;
- Dry needling of spastic upper limb muscles;
- Muscular functional electrical stimulation (FES).
干预措施: Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES) (Procedure)
Sham Group (SG)
The Sham Group also received the four modalities of the intervention, but these modalities were all inactive. For simulation of transcranial electrical stimulation and FES, electrodes were placed on the scalp and in the upper extremity muscles and were connected to a device similar to the real electric current generator. This device did not transmit any electric current but had blinking lights and produced sound to provide the subjects visual and auditory feedback. To simulate dry needling and paraspinous block, retractile needles were used. The patients were blinded to their assigned treatment group.
干预措施: SHAM Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES) (Procedure)
结局指标
主要结局
Quality of Life - SF-36 questionnaire
时间窗: 3 months
To measure patients' quality of life after the interventions for each domain. Minimum value (for each domain) = 0 (bad quality of life); Maximum value for each domain = 100 (good quality of life)
Visual analogue scale (VAS)
时间窗: 3 months
To measure patients pain after the interventions. Minimun value = 0 (Painless); Maximum value = 10 (painful)
Modified Ashworth scale
时间窗: 3 months
To measure spasticity, and shoulder, elbow and wrist active and passive goniometry was performed to measure range of motion improvement. Minimum value = 0 (No increase in tone); Maximum value = 4 (Affected part in rigid flexion and extension)
Functional independence measure (FIM)
时间窗: 3 months
To measure independence of patients after the interventions. The Functional Independence Measure (FIM) is a functional assessment with 18 items in the areas of personal care, sphincter control, mobility, communication and social-cognition, through a broad questionnaire. Minimun value = 18 (total dependence); maximum value = 126 (total independence)
次要结局
未报告次要终点
研究者
Wu Tu Hsing
Director of Center of Acupuncture of Orthopaedics and Traumatology Institute
University of Sao Paulo General Hospital