Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Traditional Physiotherapy Treatment in Primary Care - a Non-Inferiority Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Mean change in shoulder function and pain after 12 weeks using The Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
The goal of this clinical trial is to test a digital treatment for patients with subacromial pain using the digital Shoulder Aid (diSAID) strategy. The participants in this study will be randomly assigned to digital treatment (diSAID) or to receive the treatment that is currently available in primary care, i.e. continue according to usual practice.
The main question this clinical trial aims to answer are:
- Can the diSAID improve shoulder function and reduce pain for patients with subacromial pain in primary care?
详细描述
Subacromial pain is the most common shoulder complaints in the general population. The pathology is multifactorial and mainly explained by pain generated from structures in the space between the caput humeri and acromion, especially the bursa and tendons of the rotator cuff. Exercises have positive effects on shoulder function, pain and satisfaction in patients with subacromial pain and is according to current evidence the primary treatment for this condition. Surgery and exercise have been shown to have an equivalent positive effect and it is possible to avoid surgery with specific training. This means that the motive for surgery has become increasingly questionable. Despite this, many patients undergo surgery without having taken part in specific supervised training and the selection of patient's prior to surgery is still inadequate. One reason for this may be that resources in healthcare are limited. Supervised training with physical visits over a longer period of time can be difficult for the primary care to offer. This require demands on physiotherapists' skills, time and resources.
Clinical studies with digital solutions are increasing and occur in several areas of healthcare. Digital interventions have proven to be effective in several diseases and disorders and can increase access to health education in a cost-effective way.
This is a single-blind, prospective, non-inferiority randomised controlled trial, designed to evaluate the feasibility and efficacy of a digital physiotherapy treatment compared to traditional physiotherapy for patients with subacromial pain in a primary care setting. The hypothesis is that clinical outcomes of the digital physiotherapy intervention for patients with subacromial pain can be effective and non-inferior compared to traditional physiotherapy in primary care.
Further the study objective is to evaluate the cost-effectiveness and impact on the environment using a digital intervention.
Sample size calculation: The estimated sample size is based the primary outcome SPADI assuming α = 0.05, β = 0.2 with a given power of 80% and a standard deviation of 18. A non-inferiority margin is set to 10 points (δ = -10) in total SPADI scores. Consequently, 82 patients have to be included, 41 per treatment group. Due to drop outs an over recruitment is planned (Total achievement of 60 per group).
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)
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
- •>18 years old
- •Pain duration >2 weeks
- •Lateral shoulder pain (C5 dermatome)
- •At least three positive tests as follows:
- •Painful arc
- •External rotation resistance test
- •Jobe's test
- •Neer's impingement sign
- •Hawkin's-Kennedy's impingement test
排除标准
- •Symptoms are related to a traumatic event in the last 6 months with suspected rotator cuff tear, dislocation or fracture.
- •Clinical features of cervical radiculopathy
- •Clinical features of Adhesive capsulitis
- •The patient does not understand or can not read Swedish
- •The patient has no access to BankID
结局指标
主要结局
Mean change in shoulder function and pain after 12 weeks using The Shoulder Pain and Disability Index (SPADI)
时间窗: Initial, 12 weeks, 6 months, 2 year
The Shoulder Pain and Disability Index has good psychometric properties with good reliability and validity. It consists of two sub-areas, the first area includes five questions for the estimation of pain and the second area includes eight questions about the impact on activity-related function of the upper extremity. Grading of pain or functional limitation goes from 0-10 where 0 indicates "no pain or disability" and 10 indicate "maximum pain or disability". The sub-areas generate individual scales as well as a common total score that is given as a percentage. Minimal Clinically Important Difference is 8 to 13 points and Minimal Detectible Change is 18 points.
次要结局
- Mean change in shoulder pain intensity at rest, arm activity and at night measured by numeric rating scale (NRS)(Initial, 12 weeks, 6 months, 2 year)
- Mean change in pain Self-Efficacy(Initial, 12 weeks, 6 months, 2 year)
- Mean change of self-reported rating of improvement(Initial, 12 weeks, 6 months, 2 year)
- Mean change of health-related quality of life(Initial, 12 weeks, 6 months, 2 year)
研究者
Teresa Holmgren
PhD Physical therapist
Region Östergötland