Effects of TENS and Interference on Pain, Functional Status and Range of Motion in Shoulder Pain in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline VAS (visual analog scale) at 4th and 8th week
研究概览
简要总结
Effects of TENS and Interference on Pain, Functional Status and Range of Motion in Shoulder Pain in Stroke Patients
详细描述
Hemiplegic shoulder pain treatment methods are, analgesics, local steroid injection, physical therapy modalities and exercise. There are publications about the use of TENS and interferential currents (IFC) in the treatment of hemiplegia related shoulder pain and their effectiveness. However when we look at the literature, we did not find a study that evaluated the efficacy of TENS and IFC in hemiplegic shoulder pain. For this reason, in this study, we aimed to determine the effects of these analgesic treatment modalities on the patient's pain, functional status and shoulder range of motion (ROM) in these patients. 60 stroke patients with shoulder pain randomized to four treatment groups. 15 patients in Group 1 were given TENS treatment to the shoulder area for 25 minutes by conventional method ( 20 sessions, 5 times a week), then, a classical stroke rehabilitation program was applied under the guidance of a physiotherapist.. 15 patients in Group 2 were given shamTENS treatment to the shoulder area for 25 minutes ( 20 sessions, 5 times a week), then, a classical stroke rehabilitation program was applied under the guidance of a physiotherapist.15 patients in Group 3 were given 100 Hz IFC treatment to the shoulder area for 25 minutes ( 20 sessions, 5 times a week), then, a classical stroke rehabilitation program was applied under the guidance of a physiotherapist. 15 patients in Group 4 were given shamIFC treatment to the shoulder area for 25 minutes ( 20 sessions, 5 times a week), then, a classical stroke rehabilitation program was applied under the guidance of a physiotherapist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Having shoulder pain due to hemiplegia 2- Having had hemiplegia in the last 8 months 3- Having hemiplegia for the first time 4- Not having a problem in the painful shoulder before hemiplegia 5- normal light touch and pinprick tests of the affected shoulder 6- pain level in the affected extremity as measured by VAS is at least 4 7- Brunnstrom upper extremity stage with 1-2-3
排除标准
- •uncontrolled hypertension
- •Serious arrhythmias
- •Having pacemakers
- •Severe sensory impairment, wound, infection in the application area
- •bleeding disorders
- •Uncooperative patients 10- Patients with acute infection 11- Patients with a history of trauma to the painful shoulder 12- Treatment for pain in the affected shoulder (blockage, intra-articular injection, and physical therapy agent)
结局指标
主要结局
Change from baseline VAS (visual analog scale) at 4th and 8th week
时间窗: up to 8 weeks
The patients were asked to make an assesment of their pain level between 0 and 10 scale
次要结局
- Change from baseline shoulder range of motion (ROM) at 4th and 8th week(up to 8 weeks)
- Change from baseline Beck depression inventory (BDI) at 4th and 8th week(up to 8 weeks)
- Change from baseline Shoulder Disability Questionnaire (SDQ) at 4th and 8th week(up to 8 weeks)
- Change from baseline quality of life (short form 36) at 4th and 8th week(up to 8 weeks)
- Change from baseline Brunnstrom staging at 4th and 8th week(up to 8 weeks)
- Change from baseline Functional ambulation score (FAS) at 4th and 8th week(up to 8 weeks)
- Change from baseline functional independence measure (FIM) at 4th and 8th week(up to 8 weeks)
- Change from baseline modified ashworth scale (MAS) at 4th and 8th week(up to 8 weeks)
- Change from baseline fugl meyer assessment at 4th and 8th week(up to 8 weeks)
研究者
Hilal Yeşil
Assoc.Prof.
Afyonkarahisar Health Sciences University