Efficacy of High Intensity Laser Treatment in Hemiplegic Shoulder Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
High intensity laser therapy (HILT) has been considered as a treatment option for shoulder pain. In randomized controlled studies with high-intensity laser therapy (HILT), there are publications showing its effectiveness in conditions such as shoulder pathologies such as subacromial impigment syndrome and adhesive capsulitis. However, there are few studies in the literature that focus on the effectiveness of HILT, especially in hemiplegic shoulder pain. In this study, we intended to investigate the effectiveness of HILT on pain, disability, function and quality of life in patients with HSP accompanied by PTRCT.
详细描述
The study was designed as prospective, randomized, controlled trial. Participants with HSP accompanied by PTRCT (n=40) were randomly assigned to HILT and control groups. Group 1 (HILT group, n=20) received 3 sessions of HILT per week for 3 weeks in addition to the exercise program which performed 5 sessions per week for 3 weeks. Group 2 (Control group, n=20) received an exercise program for HSP of 5 sessions per week for 3 weeks.
Participants were evaluated with Visual Analog Scale (VAS), passive Range of Motion (ROM), Shoulder Pain and Disability Index (SPADI), Nottingham Health Profile (NHP), Functional Independence Measure (FIM) and ultrasonographic PTRCT size,Fugl Meyer Assessment, Brunnstrom Stages, Modified Ashworth Scale (MAS) Nottingham Health Profile (NHP).
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with HSP aged 50-85 years with hemiplegia duration> 2 months, suffered a stroke resulting in unilateral hemiplegia for the first time
排除标准
- •Cases who had inflammatory rheumatic disease, cervical radiculopathy, diabetes mellitus, thyroid disease, coronary heart disease, cardiac pace-maker, neurological disease, shoulder surgery, and shoulder injection in the last 3 months
研究组 & 干预措施
High intensity laser therapy + exercise
HILT will be applied to the patients five times a week for a period of three weeks and one session per day for a total of 15 sessions by a physical therapy technician who is experienced in using a laser device. (BTL-6000 high intensity laser 12 W, Stevenage, Hertfordshire, England). The laser device generates a maximum power of 12 W and emits a wavelength of 1064 nm (Nd: YAG laser). In the HILT group, it will be used in the rotator cuff muscles area in two stages, Phase I and Phase II. For analgesic effect in phase I. Phase II will also be applied for the biostimulation effect. Exercise program was applied in five sessions a week for three weeks, with a total of 15 sessions a day.
干预措施: High intensity laser therapy (Device)
High intensity laser therapy + exercise
HILT will be applied to the patients five times a week for a period of three weeks and one session per day for a total of 15 sessions by a physical therapy technician who is experienced in using a laser device. (BTL-6000 high intensity laser 12 W, Stevenage, Hertfordshire, England). The laser device generates a maximum power of 12 W and emits a wavelength of 1064 nm (Nd: YAG laser). In the HILT group, it will be used in the rotator cuff muscles area in two stages, Phase I and Phase II. For analgesic effect in phase I. Phase II will also be applied for the biostimulation effect. Exercise program was applied in five sessions a week for three weeks, with a total of 15 sessions a day.
干预措施: Therapeutic Exercise (Other)
Exercise only
Exercise program was applied in five sessions a week for three weeks, with a total of 15 sessions a day.
干预措施: Therapeutic Exercise (Other)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: Baseline (pre-treatment), immediately post-treatment, and at 3-week follow-up (Change in hemiplegic shoulder pain from baseline)
Severity of pain was assessed using the standart 10 cm VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end
次要结局
- Range of motion (ROM) of the hemiplegic shoulder(Baseline (pre-treatment), immediately post-treatment, and at 3-week follow-up (Change in hemiplegic shoulder ROM from baseline))
- Shoulder Pain and Disability Index (SPADI)(Baseline (pre-treatment), immediately post-treatment, and at 3-week follow-up (Change in hemiplegic arm motor recovery from baseline))
- Spastisity(Baseline (pre-treatment), immediately post-treatment, and at 3-week follow-up (Change in hemiplegic arm spasticity from baseline))
- Functional status (FIM)(Baseline (pre-treatment), immediately post-treatment, and at 3-week follow-up (Change in functional status from baseline))
- Quality of life of the hemiplegic patient(Baseline (pre-treatment), immediately post-treatment, and at 3-week follow-up (Change in quality of life from baseline))
- Fugl Meyer Assessment (upper extremity)(Baseline (pre-treatment), immediately post-treatment, and at 3-week follow-up (Change in quality of life from baseline))
研究者
Nur Doğanlar
Medical Doctor
Afyonkarahisar Health Sciences University