Clinical Outcome in Subacute Stroke Patients With Hemiplegic Shoulder Pain and Rotator Cuff Injuries After Hyaluronic Acid Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- the change from baseline on hemiplegic shoulder sonography
研究概览
简要总结
Hemiplegic shoulder pain (HSP) is one of most complications after stroke. HSP would impede rehabilitation programs and the motor recovery of affected upper extremity. HSP was associated with impaired daily life activities and prolong hospital stay after stroke. Therefore, effective managements is important in stroke patients with HSP. Rotator cuffs injuries are related to HSP. Clinically, hyaluronic acid (HA) is used for rotator cuff injuries. Previous researchers reported that HA could provide pain relief, improved motion, and increased daily activities. In this study, fifty subacute stoke patients will be enrolled. These patients will be allocated into group A and B randomly. The patients in group A received HA injection while patients in group B received normal saline injection. Patients from both groups received injection for 3 times each on the 1st, 2nd, 3rd week. All the patients will still receive rehabilitation programs of physical therapy and occupational therapy. Each patient will receive physical, sonographic examinations, and stroke Specific Quality of Life Scale (SSQOL). The aims of this study are to investigate the benefits of HA injection on pain relief, motor function recovery, and life quality in subacute stroke patients with HSP before and after HA injection.
详细描述
In this study, a two-year program is expected to receive a total cases of 50 subacute stroke patients with hemiplegic shoulder pain. The patients are randomly divided into two groups. In experimental group, the patients (25 people) will accept the shoulder hyaluronic acid injections for pain management. In control group, the patients (25 people) will receive 0.9% physiological saline injections. All participants will receive total 3 times shoulder injections at the 1st, 2nd, 3rd week. Except shoulder injections, stroke patients may receive regular rehabilitation program including physical therapy and occupational therapy. All measurements including shoulder sonography, physical examinations, and the questionnaire for life quality (SSQOL) will be conducted before the first injection, after completing shoulder injection, and 3/6 months after shoulder injection. Shoulder sonography is used to investigate shoulder soft tissue condition of hemiplegic shoulder including biceps tendon, infraspinatus tendon, supraspinatus tendon, subscapularis tendon, and subdeltoid bursa in this study. The physical examination includes all shoulder motion plane, shoulder sensory (light touch, pinprick, and position sense) and motor function (Fual Meyer scale and brunnstrom motor recovery stage), shoulder spasticity measured by modified Ashworth scale, and hemiplegic shoulder pain by visual analog scale. The investigators use Stroke Specific Quality of Life Scale to evaluate the quality of life in stroke patients with HSP. In this study, the investigators want to explore the short and long term effects of HA injection on pain relief, motor function recovery, and life quality in stroke patients with HSP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subacute stroke patients with hemiplegic shoulder pain
排除标准
- •previous shoulder pain or injury in recent 6 months
- •local infection near the injection area
- •shoulder arthropathy
- •systemic neuromuscular disease;
- •severe cardiovascular or pulmoanry disease
- •impaired cognition function leading to poor communication
研究组 & 干预措施
Hyaluronic Acid
injection Hyaluronic Acid 2.5ml and physical therapy and occupational therapy
干预措施: Hyaluronic Acid (Drug)
Placebo group
Injection 0.9% Physiological saline solution<2.5 ml and physical therapy and occupational therapy
干预措施: physical therapy and occupational therapy (Other)
Placebo group
Injection 0.9% Physiological saline solution<2.5 ml and physical therapy and occupational therapy
干预措施: Physiological saline solution (Drug)
Hyaluronic Acid
injection Hyaluronic Acid 2.5ml and physical therapy and occupational therapy
干预措施: physical therapy and occupational therapy (Other)
结局指标
主要结局
the change from baseline on hemiplegic shoulder sonography
时间窗: 1 week , 4th week, 3 month and 6 month
use sonographic to investigate the soft tissues surrounding the hemiplegic shoulder
次要结局
- shoulder pain(1 week , 4th week, 3 month and 6 month)
- motor function(1 week , 4th week, 3 month and 6 month)
- shoulder range of motion(1 week , 4th week, 3 month and 6 month)
- Quality of Life(1 week , 4th week, 3 month and 6 month)
- shoulder sensory(1 week , 4th week, 3 month and 6 month)
- shoulder spasticity(1 week , 4th week, 3 month and 6 month)