The Effect of the Treatment Environment on Pain, Function, Self Efficacy and Satisfaction in Rotator Cuff Related Shoulder Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
Brief Summary
The aim of this randomized controlled study is to reveal the short-term effects of physical and social factors in different therapeutic environments on patients with rotator cuff related shoulder pain following the same exercise program. The main questions it aims answer are:
- Is there any difference in terms of pain levels among groups with rotator cuff related shoulder pain who treated in different therapeutic settings.
- Is there any difference in terms of functionality and self-efficacy among groups with rotator cuff related shoulder pain who treated in different therapeutic settings.
详细描述
The investigators will include patients who applied to the physiotherapy clinic of Kadikoy Florence Nightingale Medical Center with the complaint of shoulder pain. 46 individuals who volunteer to participate in the study will be included. Participants will be randomised through a computer-based randomization program into two groups; the enriched therapeutic environment group (Group 1) and the isolated therapeutic environment group (Group 2). The same treatment including patient education, exercise therapy and ice application will be performed to both groups. Participants will receive a total of 15 sessions of treatment, 3 sessions per week. Before the treatment, 3rd week and 6th week, the following evaluations will be made to both groups; Numerical Pain Rating Scale (NPRS) to asses pain, Arm, Shoulder, Hand Problems Quick Survey (Quick-DASH) and Western Ontario Rotator Cuff Index (WORC) to asses functionality, Pain Self-Efficacy Questionnaire (PSEQ) to asses self efficacy and Global Scale of Change (GRC) to asses the effectiveness of the treatment.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 单盲 (结局评估者)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 18-75 years old
- diagnosed with impingement syndrome, subacromial bursitis, rotator cuff tendinopathy or partial rotator cuff tear
- pain level between 3-7 according to visual analog scale
- pain persisted for at least 3 months
排除标准
- having a full-thickness or massive rotator cuff tear
- history of shoulder surgery
- having a musculoskeletal disease that prevents exercise
- having a neurological disease or psychological disorder
研究组 & 干预措施
The isolated therapeutic environment group (Group 2).
Group 2 will receive treatment in a quiet single room. The room is illuminated by artificial light, curtains are closed so that patients cannot see outside view. Patients will receive a treatment consisting of patient education, exercise therapy and cold application for a total of 15 sessions, 3 times a week. Each session will last approximately 60 minutes. After the patient education and exercise therapy is completed, the participants will rest silently for 15 minutes of cold application.
干预措施: Exercise Therapy (Behavioral)
The enriched therapeutic environment group (Group 1)
Group 1 will receive treatment in a physiotherapy unit which has following characteristics ; enlightened with sunlight, has a view of green trees and includes other participants exercising. This enviroment also had an intrumental music playing in the background. Patients will receive a treatment consisting of patient education, exercise therapy and cold application for a total of 15 sessions, 3 times a week. Each session will last approximately 60 minutes. After the patient education and exercise therapy is completed, the participants will rest for 15 minutes of cold application.
干预措施: Patient Education (Behavioral)
The enriched therapeutic environment group (Group 1)
Group 1 will receive treatment in a physiotherapy unit which has following characteristics ; enlightened with sunlight, has a view of green trees and includes other participants exercising. This enviroment also had an intrumental music playing in the background. Patients will receive a treatment consisting of patient education, exercise therapy and cold application for a total of 15 sessions, 3 times a week. Each session will last approximately 60 minutes. After the patient education and exercise therapy is completed, the participants will rest for 15 minutes of cold application.
干预措施: Exercise Therapy (Behavioral)
The enriched therapeutic environment group (Group 1)
Group 1 will receive treatment in a physiotherapy unit which has following characteristics ; enlightened with sunlight, has a view of green trees and includes other participants exercising. This enviroment also had an intrumental music playing in the background. Patients will receive a treatment consisting of patient education, exercise therapy and cold application for a total of 15 sessions, 3 times a week. Each session will last approximately 60 minutes. After the patient education and exercise therapy is completed, the participants will rest for 15 minutes of cold application.
干预措施: Cold Application (Behavioral)
The isolated therapeutic environment group (Group 2).
Group 2 will receive treatment in a quiet single room. The room is illuminated by artificial light, curtains are closed so that patients cannot see outside view. Patients will receive a treatment consisting of patient education, exercise therapy and cold application for a total of 15 sessions, 3 times a week. Each session will last approximately 60 minutes. After the patient education and exercise therapy is completed, the participants will rest silently for 15 minutes of cold application.
干预措施: Patient Education (Behavioral)
The isolated therapeutic environment group (Group 2).
Group 2 will receive treatment in a quiet single room. The room is illuminated by artificial light, curtains are closed so that patients cannot see outside view. Patients will receive a treatment consisting of patient education, exercise therapy and cold application for a total of 15 sessions, 3 times a week. Each session will last approximately 60 minutes. After the patient education and exercise therapy is completed, the participants will rest silently for 15 minutes of cold application.
干预措施: Cold Application (Behavioral)
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: Baseline, 3rd week, 6th week
Participants' pain at rest, at night and during activity was measured using the NPRS. The NPRS is an 11-point scale that can be scored from 0 to 10. A score of zero (0) indicates "no pain" and 10 indicates score defines "the most severe pain". The patient will be asked to mark shoulder pain on the scale
次要结局
- Quick - The Disabilities of the Arm, Shoulder and Hand (Quick DASH) Questionnaire(Baseline, 3rd week, 6th week)
- Western Ontario Rotator Cuff (WORC) Index(Baseline, 3rd week, 6th week)
- Pain Self-Efficacy Questionnaire (PSEQ)(Baseline, 3rd week, 6th week)
- Global Rating of Change, GRC(Baseline, 3rd week, 6th week)
研究者
Merve Koyuncu Cenikli
Research Asistant, PT
Istanbul University - Cerrahpasa
研究点 (1)
标识符
- NCT 编号
- NCT06449534
- 其他研究编号
- 2150060
日期
- 首次提交
- (2年前)
- 首次发布
- (2年前)
- 主要完成日期
- (去年)
- 研究完成日期
- (去年)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否