Exercise Into Pain in Chronic Rotator Cuff Related Shoulder Pain: a Prospective Single-Group Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Rate of Adherence (Physiotherapy Session)
研究概览
简要总结
The purpose of this study is to evaluate a) the feasibility of applying a painful exercise program in the treatment of subacromial shoulder pain and b) the time needed to collect clinical outcomes for a future randomized controlled trial.
详细描述
Exercise therapy is the first choice of treatment in the management of subacromial shoulder pain (SSP). Guidelines suggest active rehabilitation program for at least three months and existing research highlights the importance of progressive loaded exercise therapy at higher dosage. However, it is not clear which is the best type of exercise and if pain should be provoked during exercise. Recent research found that painful exercises are beneficial in short term on pain and function in patients with different kinds of chronic musculoskeletal pain. The aim of the future randomized clinical trial is to investigate if "exercising into pain" gives better results in term of clinical outcomes compared to a non-painful exercise program. Since the intervention consists in painful exercises, it is essential to test the rate of adherence in the intervention group (both during physiotherapist-led session and home-based exercises). Moreover, the practicability of clinical questionnaire via online survey will be tested and the time needed to collect clinical data will be calculated as well. Furthermore, feedback from physiotherapists and participants will be collected and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Shoulder pain for at least 3 months
- •Pain in the antero-lateral shoulder region
- •At least 3 out of 5 of the following tests positive: Neer test, Hawkins-Kennedy, Jobe, painful arc between 60° and 120°, external resistance test
- •Resting pain should be at 2/10 maximum on verbal NRS scale
- •All types of occupations were included: students, workers (including overhead workers or heavy duty workers), people on sick leave and retired people
排除标准
- •Bilateral shoulder pain
- •Corticosteroid injections 6 weeks prior to the study
- •Pregnancy, inability to understand spoken or written Dutch
- •Clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests and drop arm test)
- •Evidence of adhesive capsulitis (50% or more than 30° loss of passive external rotation)
- •Previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder
- •Symptoms of cervical radiculopathy as primary complaint (tingling, radiating pain in the arm associated with neck complaints)
- •Primary diagnosis of acromioclavicular pathology, shoulder instability
- •A radiologically confirmed fracture or presence of calcification larger than 5 mm
- •Presence of competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy)
- •More than 4h of training in sport overhead shoulder activities per week
结局指标
主要结局
Rate of Adherence (Physiotherapy Session)
时间窗: measurement every session, final measure at the end of 12 weeks
It is analysed in terms of attendance to the physiotherapist-led sessions. Good level of adherence is defined by attendance of 7/9 (78%) of physiotherapist led-sessions
Rate of Adherence (Adherence Home Exercises)
时间窗: measurement every home exercise session, final measure at the end of 12 weeks
It is analysed in terms of adherence to home exercises. Good level of adherence is achieved when patients completed at least 22 of 27 (81%) sessions. One session of non-supervised (home) exercise was considered completed when at least 80% of the total amount of sets and repetitions were executed as prescribed by the physiotherapist.
Shoulder Pain and Disability Index (SPADI)
时间窗: value at baseline minus value at 12 weeks
There are 13 items, divided in two subscales: pain (5 items) and function (8 items). Each item is scored from 0 (no pain/no difficulty) to 10 (worst imaginable pain/so difficult it requires help) on a NPRS. The final score is a percentage derived from an average of the two subscales, where higher score means worse outcome.
次要结局
- MVC in Scaption(values at 12 weeks minus baseline)
- Fear-Avoidance Beliefs Questionnaire (FABQ-PA)(value at baseline minus value at 12 weeks)
- Fear-Avoidance Beliefs Questionnaire (FABQ-W)(value at baseline minus value at 12 weeks)
- Fear of Pain Questionnaire (FPQ-9)(value at baseline minus value at 12 weeks)
- Passive Range of Motion (ROM) in External Rotation(value at 12 weeks minus baseline)
- Passive ROM in Internal Rotation(value at 12 weeks minus baseline)
- Passive ROM in Scaption(value at 12 weeks minus baseline)
- Active ROM in External Rotation(value at 12 weeks minus baseline)
- Active ROM in Internal Rotation(value at 12 weeks minus baseline)
- Active ROM in Scaption(value at 12 weeks minus baseline)
- Maximum Voluntary Contraction (MVC) in External Rotation(value at 12 weeks minus value at baseline)
- MVC in Internal Rotation(values at 12 weeks minus values at baseline)
研究者
Filip Struyf
Professor
Universiteit Antwerpen