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临床试验/NCT04738461
NCT04738461撤回不适用

The Effectiveness of Telerehabilitation in Patients With Subacromial Pain Syndrome: a Randomized Controlled Trial

Bezmialem Vakif University2 个研究点 分布在 1 个国家开始时间: 2022年2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
撤回
试验地点
2
主要终点
Change from Baseline Pain Intensity at 1 and 3 months

研究概览

简要总结

The main hypothesis of the study is that telerehabilitation is an effective treatment method and it is not inferior than standard physiotherapy.The aim of this study is to evaluate the effectiveness of telerehabilitation in patients with subacromial pain syndrome by comparing it with standard physiotherapy.

详细描述

Subacromial pain syndrome formerly known as subacromial impingement syndrome is the cause of approximately 44% to 65% of pain complaints related to the shoulder. Methods such as immobilization, drug therapy, injection techniques, physical therapy modalities and therapeutic exercises, manual therapy, acupuncture and surgery can be used in the treatment of the disease. Due to the Coronavirus disease 2019 (COVID-19) pandemic that started in Wuhan province of China in December 2019, the problems in patients' access to hospitals and rehabilitation services caused telerehabilitation to be on the agenda. Telerehabilitation can be summarized as the delivery of rehabilitation services to those in need by using communication technologies. This method covers the steps of evaluation, monitoring, prevention, intervention, control, training, and consultation. Although there are many studies on the effectiveness of telerehabilitation in the literature, there is no study on the superiority of telerehabilitation, physical therapy under supervision and home exercise program over each other.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

Participants will not be able to be blinded due the inherent of interventions. Staff members who are responsible for statistical analysis, investigators and outcome assessors will be blinded.

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

  • •Having subacromial pain for at least 2 weeks
  • •Positive result of Hawkins-Kennedy, painful arc or infraspinatus muscle strength tests .
  • •To have internet access and equipment to participate in videoconference .
  • •Being literate and not having cognitive dysfunction.

排除标准

  • •Positive drop arm test
  • •Signs of adhesive capsulitis (restriction in range of motion-especially in abduction and external rotation)
  • •Grade 3 or full thickness rotator cuff tear
  • •Labral tears and other intraarticular structural pathologies
  • •History of shoulder surgery

研究组 & 干预措施

Telerehabilitation

Experimental

Telerehabilitation program will be applied 5 days a week for 3 weeks to patients in the telerehabilitation group. A physiatrist will meet with patients via videoconferencing over the internet and guide the program.

干预措施: Telerehabilitation (Other)

Standard Physiotherapy

Active Comparator

Patients in the standard physiotherapy group will receive one-to-one physiotherapy sessions in the hospital 5 days a week for 3 weeks. In these sessions, active-passive exercises accompanied by a physiotherapist and physical therapy methods (electrotherapy and thermotherapy) will be applied in accordance with the standard procedure according to the patient's needs.

干预措施: Standard Physiotherapy (Other)

Home exercise group

Active Comparator

The home exercise program was explained to the patients in the control group by the physiotherapist and the relevant brochures were delivered to the patients. Home exercise program will consist of telerehabilitation group exercises. However, patients will be not under any supervision and exercise themselves at home.

干预措施: Home Exercise Group (Other)

结局指标

主要结局

Change from Baseline Pain Intensity at 1 and 3 months

时间窗: Baseline, one and three month after the randomisation

Patients will be asked to mark their pain by giving a score between zero (no pain) and 10 (the most severe pain) on a 10 cm long visual analog scale (VAS) during each visits.

次要结局

  • Change from Baseline SPADI total score at 1 and 3 months(Baseline, one and three month after the randomisation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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