Investigation of the Effectiveness of Flossing in Hemiplegic Patients With Shoulder Pain: Randomized Controlled Trial
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
- 2
- 主要终点
- Shoulder Pain and Disability Index
研究概览
简要总结
This study aims to contribute to clinical practice by investigating the effectiveness of flossband application on range of motion, functionality, pain and sleep quality in hemiplegic patients with shoulder pain.
详细描述
This study will be conducted at the NRL Physical Therapy Center. Participants must sign an informed consent form before starting the study. Participants will be randomly assigned to two groups: a control and an experimental group. A Visual Analog Scale will be used to assess pain. A score of 0 represents no pain, and a score of 10 represents unbearable pain. The Pittsburgh Sleep Quality Scale will be used to assess sleep quality. Assessments will be made before starting treatment and at the end of treatment after 6 weeks. The experimental group will receive conventional physical therapy and flossband application. This group will receive conventional physical therapy and flossband application three sessions per week, each session lasting approximately 40-50 minutes, for 6 weeks. The flossband application will cover the area around the shoulder joint (specifically the deltoid, pectoralis major, and subscapularis line). A spiral bandage will be applied starting from the mid-distal portion of the deltoid muscle, working distally from proximal to distal.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with a clinical diagnosis of stroke
- •Individuals between the ages of 30 and 55
- •Individuals experiencing hemiplegic shoulder pain (VAS ≥ 3) and/or limited joint movement
- •Individuals who have been at least 6 months post-stroke (chronic phase)
- •Individuals who have an active range of motion of at least 90° in shoulder flexion and abduction
- •Individuals with stable vital signs
- •Individuals who volunteer to participate in the study and who understand the purpose and process of the study and sign a written informed consent form
排除标准
- •Presence of serious orthopedic problems such as shoulder fractures, dislocations, or rotator cuff tears
- •Presence of skin lesions or circulatory disorders that may prevent flossband application
- •Spasticity in the affected arm (Modified Ashworth Scale ≥1)
- •Those with a latex allergy to the flossband material
- •Those with acute inflammatory conditions or acute pain
研究组 & 干预措施
control
conventional physiotherapy
干预措施: control (Other)
flossing group
conventional physiotherapy + flossing
干预措施: flossing (Other)
结局指标
主要结局
Shoulder Pain and Disability Index
时间窗: 6 weeks
It's a self-reported questionnaire consisting of two subgroups: pain and shoulder disability level. It consists of 13 questions: five for pain and eight for shoulder disability level. In the pain section, a visual analog scale score of 0 indicates no pain and 10 indicates the most severe pain. In the shoulder disability level section, a score of 0 indicates no difficulty and 10 indicates very difficult (I need help). Scoring is performed by measuring the distance between the individual's chosen point and 0 using a ruler and recording the score in centimeters. The total score is calculated by averaging the two subgroup scores. A higher score indicates shoulder pain and functional impairment.
The Pittsburgh Sleep Quality Index
时间窗: 6 weeks
Pittsburgh Sleep Quality Index; It evaluates sleep duration, sleep disturbance, sleep efficiency, subjective sleep quality, sleep medication use, daytime dysfunction, and sleep delay and consists of a total of 24 questions. 19 of them are self-report scales and 5 of them consist of questions to be answered by a friend or spouse. There are 7 components with 18 questions scored in the scale, and each component is evaluated between 0 and 3 points. The total score ranges from 0 to 21, and 5 or more is an indicator of "poor sleep quality".
Shoulder Pain and Disability Index
时间窗: 8 weeks
It's a self-reported questionnaire consisting of two subgroups: pain and shoulder disability level. It consists of 13 questions: five for pain and eight for shoulder disability level. In the pain section, a visual analog scale score of 0 indicates no pain and 10 indicates the most severe pain. In the shoulder disability level section, a score of 0 indicates no difficulty and 10 indicates very difficult (I need help). Scoring is performed by measuring the distance between the individual's chosen point and 0 using a ruler and recording the score in centimeters. The total score is calculated by averaging the two subgroup scores. A higher score indicates shoulder pain and functional impairment.
The Pittsburgh Sleep Quality Index
时间窗: 8 weeks
Pittsburgh Sleep Quality Index; It evaluates sleep duration, sleep disturbance, sleep efficiency, subjective sleep quality, sleep medication use, daytime dysfunction, and sleep delay and consists of a total of 24 questions. 19 of them are self-report scales and 5 of them consist of questions to be answered by a friend or spouse. There are 7 components with 18 questions scored in the scale, and each component is evaluated between 0 and 3 points. The total score ranges from 0 to 21, and 5 or more is an indicator of "poor sleep quality".
次要结局
未报告次要终点
研究者
Doç.Dr.Ömer Şevgin
Assoc.Prof.Dr.
Uskudar University