The Effect of a Dual-Task Technique-Based Exercise Program on Clinical Outcomes in Rotator Cuff Related Shoulder Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
The aim of this clinical trial is to investigate the effects of a dual-task-based exercise program on clinical outcomes in individuals with rotator cuff-related shoulder pain. The study will evaluate the effects of a dual-task exercise approach, in which physical exercises are performed concurrently with cognitive tasks, on pain, functional status, pain catastrophizing and kinesiophobia. These results will be compared with those of a standard shoulder rehabilitation program. The main questions this study aims to answer are:
- Is there a difference in pain levels between individuals with rotator cuff-related shoulder pain who participate in a dual-task-based exercise program and those who participate in a standard exercise program?
- Is there a difference between these two exercise approaches in terms of shoulder function and psychosocial factors?
Participants will:
- Participate in either a dual-task-based shoulder exercise program or a standard shoulder exercise program twice per week for 6 weeks.
- Undergo clinical assessments at baseline, at week 6, and at week 12.
详细描述
A total of 46 patients will be included in the study based on the results of a power analysis. Participants will be randomly allocated into two groups using a computer-based randomization program: the Dual-Task Technique-Based Exercise Group (Group 1) and the Standard Exercise Group (Group 2). Both groups will receive patient education and participate in a supervised exercise program. In the Dual-Task Technique-Based Exercise Group, exercise sessions will be performed concurrently with cognitive tasks. The Standard Exercise Group will undergo a standard shoulder exercise program without cognitive task integration. The intervention will be administered twice per week for a total of 12 sessions over a 6-week period. Clinical assessments will be conducted for both groups at baseline (before treatment), at the end of the intervention (week 6), and at week 12 as a follow-up assessment. The primary outcome measure will be pain intensity, assessed using the Numeric Pain Rating Scale (NPRS). Secondary outcome measures will include the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (Q-DASH), the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), the Pain Catastrophizing Scale (PCS) and the Tampa Scale of Kinesiophobia-11 (TSK-11).
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 65 years
- •Diagnosis of impingement syndrome, subacromial bursitis, rotator cuff tendinopathy, or partial rotator cuff tear
- •Shoulder pain level ≥3 according to the Numeric Pain Rating Scale (NPRS)
- •Shoulder pain persisting for at least 3 months
排除标准
- •Diagnosis of shoulder instability, adhesive capsulitis, or full-thickness or massive rotator cuff tear
- •Presence of musculoskeletal, neurological, and/or psychological conditions that would prevent participation in an exercise program
- •History of shoulder surgery
- •Having received physiotherapy or corticosteroid injection treatment for shoulder pain within the past 6 months
- •Presence of cognitive impairment that would prevent participation in dual-task exercise activities
研究组 & 干预措施
Dual-Task Technique-Based Exercise Group
Patients will receive a treatment program consisting of patient education and exercise therapy twice per week for a total of 12 sessions. Exercise sessions will be performed concurrently with cognitive tasks.
干预措施: Patient Education (Other)
Dual-Task Technique-Based Exercise Group
Patients will receive a treatment program consisting of patient education and exercise therapy twice per week for a total of 12 sessions. Exercise sessions will be performed concurrently with cognitive tasks.
干预措施: Dual-Task-Based Exercise Therapy (Other)
Standard Exercise Group
Patients will receive a treatment program consisting of patient education and exercise therapy twice per week for a total of 12 sessions, following a standard shoulder exercise approach.
干预措施: Patient Education (Other)
Standard Exercise Group
Patients will receive a treatment program consisting of patient education and exercise therapy twice per week for a total of 12 sessions, following a standard shoulder exercise approach.
干预措施: Standard Exercise Therapy (Other)
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: At baseline, at week 6, and at week 12
NPRS will be used to evaluate pain levels. The scale consists of a numeric rating system ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will be asked to rate the intensity of their shoulder pain.
次要结局
- Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)(At baseline, at week 6, and at week 12)
- The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)(At baseline, at week 6, and at week 12)
- Pain Catastrophizing Scale (PCS)(At baseline, at week 6, and at week 12)
- Tampa Scale of Kinesiophobia-11 (TSK-11)(At baseline, at week 6, and at week 12)
研究者
Derya Celik
Professor
Istanbul University - Cerrahpasa