Development and Evaluation of Efficacy of a Web App With Multimedia Animations to Teach Therapeutic Exercise in Shoulder Pain Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Correctness in exercise performance
研究概览
简要总结
The aim of this trial is to develop and evaluate a web app to teach patients about how to correctly perform a tailored program of shoulder exercises.
The exercise program will be evidence based, and there will be two groups in the study, both exercising. The follow up will be of 6 months.
详细描述
The web app will consist of 3D multimedia animations (video and audio) which the patient will be able to access from any device with internet connection (cell phone included).
The trial will include patients with shoulder pain because of rotator cuff tendinopathy.
The investigators will carry on a pilot study with 100 patients randomly distributed into two groups, with 6 months follow up. Both groups will perform the same treatment, but the control group won´t use the exercise app. There will be four dependent variables: correct exercise performance, compliance degree, satisfaction with the treatment and expectations to improve with treatment. As secondary dependent variables will be analyzed pain (at rest, with movement and at night), functional disability (SPADI questionnaire), and patient´s assessment of app video characteristics (usability, utility and satisfaction) and co-interventions.
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 trial will be simple blinded because of the impossibility to blind patients nor physiotherapists to treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 with uni or bilateral shoulder region pain
- •Being able to read and write in Spanish
- •Pain for at least 3 months
- •Pain intensity (in rest, activity and/or at night) of at least 3/10
- •Two positive clinical sings at least from: Neer sign, Hawkins-Kennedy sign, empty can or pain arc
- •Must have and use at least 3 times/week email of their own and a device with internet connection
排除标准
- •Polyarticular or generalized pain
- •Cognitive impairment
- •Serious neurological disease
- •Other shoulder pain causes
- •History of main trauma
- •Sings or symptoms of cervical pain (excluding upper trapezius) or cervical radiculopathy
- •Apprehension sing, sulcus sing
- •Passive movement limitation (but final degree in horizontal abduction or extension)
- •Tendon rupture in ultrasound
- •Glenohumeral arthritis in plain radiographs or calcium bigger than 5mm
研究组 & 干预措施
Web app exercises
An evidence based exercise program for the shoulder pain. Web application with multimedia animations with the tailored exercise program for each patient in this group.
干预措施: Web app exercises program (Behavioral)
Exercises
An evidence based exercise program for the shoulder pain.
干预措施: Exercise program (Behavioral)
结局指标
主要结局
Correctness in exercise performance
时间窗: 6 weeks
25% of patients enrolled will be checked by video recording of 3 exercise performance, and the videos will be graded by two blinded assessors with a 6 points scale, 4 evaluating motor memory and 2 evaluating declaratory memory. Every exercise recording will be form 0 to 6, so the total score will range from 0 to 18.
Compliance degree
时间窗: 6 months
It will be measured by a simple monthly diary where the patient will have to register everyday if has done or not the exercises and the degree of pain every week. Total score will correspond to the percentage of days exercising over the total expected.
Treatment satisfaction: numerical visual scale
时间窗: 6 months
This outcome will be measured with a numerical visual scale of 11 points, where on the right will be "10" as completely satisfied, and on the left "0" absolutely unsatisfied.
Expectancy of improvement with treatment
时间窗: 2 weeks
This outcome will be measured using a modified question from the "Credibility/expectancy Questionnaire", that will be pointed on a numerical visual scale of 11 points having on the right "10" as complete recovery, and on the left "0" as "no improvement". The question that will be made is "how much improvement do you think you will reach in your limitations because of the shoulder pain?"
次要结局
- Functional limitation(6 months)
- Evaluation of the app and videos(3 months)
- Pain intensity: numerical scale(6 months)