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临床试验/NCT04322864
NCT04322864已完成不适用

Telerehabilitation Intervention for Individuals With Shoulder Pain: Randomized Controlled Trial

Universidade Federal de Sao Carlos1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2021年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
184
试验地点
1
主要终点
Change in baseline Shoulder Pain and Disability to 12 weeks

研究概览

简要总结

Introduction: Shoulder pain is a condition of high prevalence in the general population. Studies indicate that physiotherapeutic treatment with exercise is effective in reducing pain and restoring function in patients with shoulder pain. Patients may have difficulty accessing the physiotherapy service due to the cost of treatment, transportation to the service, and long waiting lines. A possible solution is the use of a telerehabiliation intervention to increase access to physiotherapy for shoulder pain patients. Objective: To assess the effectiveness of telerehabilitation when compared to in-person physiotherapy on pain and disability in individuals with persistent rotator cuff related shoulder pain. Methods: This study is a controlled, randomized, blinded clinical trial. A total of 184 individuals with shoulder pain were randomly assigned to two groups. One group received a telerehabiliation intervention and the other group received the in-person intervention. The intervention consisted of strengthening exercises with emphasis on the lateral rotator and scapulothoracic muscles. The primary outcome was pain and disability (SPADI, Shoulder Pain and Disability Index), and the secondary outcomes were pain intensity (NPRS, Numerical Pain Rating Scale), function (DASH questionnaire, Disabilities of the Arm, Shoulder and Hand), self-efficacy (CPSS, Chronic Pain Self-Efficacy Scale), kinesiophobia (Cover Scale), patient expectation of treatment (7-point Likert Scale), and patient self-perceived improvement (Global Change Assessment Scale). All outcomes were measured before and after 12 weeks of treatment (2x/week). Normality of data was verified by Kolmogorov Smirnov's test. Differences between groups were assessed using the mixed linear models including the group × time interaction. The effect size was calculated for the variables between the groups. The significance level was set at 5%.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-60;
  • •Self-reported pain of intensity equal to or greater than 3 points on the numerical pain scale (NDT) at rest or arm movement in the anterolateral region of the shoulder;
  • •Duration of at least 3 months of shoulder pain;

排除标准

  • •History of trauma related to the onset of symptoms;
  • •History of clavicle, scapula or humerus fracture;
  • •History of surgical stabilization or rotator cuff repair;
  • •History of shoulder dislocation;
  • •Pain related to the cervical spine;
  • •Adhesive capsulitis;
  • •Systemic disease involving the joints and cognitive alteration that makes it impossible to carry out questionnaires or use the mobile application.

研究组 & 干预措施

In-person supervised intervention

Active Comparator

干预措施: Therapeutic exercises (Other)

Web-based instrument intervention

Experimental

干预措施: Therapeutic exercises (Other)

结局指标

主要结局

Change in baseline Shoulder Pain and Disability to 12 weeks

时间窗: Pre (baseline) treatment, post treatment (12 weeks)

Shoulder Pain and Disability will be measured with Shoulder Pain and Disability Index with scores ranging from 0 to 100 (higher score reflects higher pain and disability)

次要结局

  • Change in baseline Pain to 12 weeks(Pre (baseline) treatment, post treatment (12 weeks))
  • Change in baseline Function to 12 weeks(Pre (baseline) treatment, post treatment (12 weeks))
  • Change in baseline Self-efficacy to 12 weeks(Pre (baseline) treatment, post treatment (12 weeks))
  • Change in baseline Kinesiophobia to 12 weeks(Pre (baseline) treatment, post treatment (12 weeks))
  • Patients' Self-perception of improvement with the treatment at 12 weeks(Post treatment (12 weeks))
  • Patients' expectation with the treatment at baseline(Pre (baseline) treatment)

研究者

发起方
Universidade Federal de Sao Carlos
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vander Gava

Principal Investigator

Universidade Federal de Sao Carlos

研究点 (1)

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