Impact of Teleexercise and Remote Assessments in Rotator Cuff Syndrome: A Comparative Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Pain Levels
研究概览
简要总结
Rotator Cuff Syndrome (RCS) often lead to shoulder pain and reduced function, creating a demand for alternative treatments. This study examines the effectiveness of remote assessments and tele-exercise compared to traditional in-person methods for treating these injuries. The telemedicine group will receive remote consultations and asynchronous exercise videos, while the control group will have face-to-face meetings and comprehensive information. Follow-up assessments will track exercise compliance for both groups. Additionally, a questionnaire will assess functionality, and pain levels will be evaluated using a pain scale, providing a comprehensive evaluation of treatment outcomes.
详细描述
This study employs a randomized controlled clinical trial with a parallel design conducted at a hospital-based Physical Therapy and Rehabilitation Clinic. The study is planned to involve 76 voluntary participants.
Inclusion criteria for participants encompass the following: participants must be within the age range of 30 to 65, diagnosed with conditions such as rotator cuff tendinosis, tendinitis, impingement, or partial rupture, confirmed through shoulder MR imaging, have not experienced improvement through conservative methods (e.g., activity restriction, ice application, and analgesics), and must have been referred for physical therapy sessions.
Participants will be randomly assigned to two groups, with efforts to maintain balance in terms of age and gender distribution. Data collection methods include detailed documentation of participants' clinical diagnoses and demographic information (e.g., age, gender, education level, occupation, dominance of the affected side, and whether the occupation involves physical labor or heavy lifting).
Before the study commences, all participants will receive comprehensive explanations of the study's objectives, provide informed consent by signing consent forms, and share their contact information for communication purposes. Participants will be informed of their rights to discontinue treatment at any point and to reach out to the researcher with questions or concerns during the study.
Participants in the Exercise Group will have face-to-face assessments at the clinic on the first day. This includes completing the Quick- Disabilities of the Arm, Shoulder and Hand (Quick- DASH) questionnaire and the Numeric Visual Analog Scale (VAS) for pain assessment. They will receive information about their condition, a brochure containing a home exercise program, and an exercise diary to record exercise details. Follow-up assessments will occur on the 7th and 15th days at the clinic.
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)
盲法说明
The person conducting the statistical analysis will be unaware of group identities, she will perform the data analysis without knowledge of which group received which treatment.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having a diagnosis of rotator cuff tendinosis, tendinitis, impingement, or partial muscle rupture confirmed by shoulder MRI,
- •Not benefiting from conservative methods such as activity restriction, ice application and analgesics, being referred to physical therapy sessions,
- •Having single-sided shoulder problem, possessing the ability to understand and perform prescribed exercises,
- •Having the cognitive and psychological capacity to read and interpret brochures, being familiar to smartphones for accessing digital exercise materials,
- •Having internet access.
排除标准
- •Cognitive impairment,
- •Bilateral rotator cuff syndrome,
- •Total rupture of rotator cuff muscle,
- •Previous fractures or surgeries on the same shoulder,
- •Shoulder instability,
- •Visual impairments,
- •Extremity amputations,
- •Advanced cancer and complicated diabetes,
- •Recent injections to the same shoulder within the last 6 months,
- •Having received physical therapy or home exercise advice within the last 6 months,
- •Lacking personal smartphones or internet access,
- •Undergoing cancer treatment.
结局指标
主要结局
Pain Levels
时间窗: At the first day, the 15th day and the 6th month of the study.
Assessments of pain intensity using the numeric-Visual Analog Scale (VAS). The numeric-VAS typically ranges from 0 to 10, with 0 representing no pain or symptom and 10 representing the worst imaginable pain or symptom. The highest score on the VAS is 10, indicating the most severe pain or symptom.
Functional Recovery
时间窗: At the first day and the 15th day of the study.
Evaluation of upper extremity function using the Quick-Disabilities of Arm, Shoulder, Hand (DASH) questionnaire. The Quick-DASH score can range from 0 to 100, with higher scores indicating more severe disability or symptoms. A score of 0 would mean no disability or symptoms, while a score of 100 would suggest the most severe disability or symptoms. Generally, a lower Quick-DASH score represents better functioning and less disability.
Exercise Adherence
时间窗: From the first day till the 15th day of the study (15 days time frame).
Monitoring and recording participants' adherence to the prescribed home exercise program through exercise diaries. This would involve tracking the frequency and consistency of exercise performance.
次要结局
- Patient Satisfaction with Likert Satisfaction Scale(From the first day till the 15th date of the study (15 days time frame).)
- Evaluating Travel Distance and Time for Control Group In-Person Hospital Visits(Data will be collected on the first day of the study.)
研究者
Selkin Yılmaz Muluk
MD, Physical Therapy and Rehabilitation specialist
Antalya Training and Research Hospital