Exercise Into Pain in Subacromial Shoulder Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
The aim of the 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.
详细描述
Exercise therapy is the first choice of treatment in the treatment of subacromial shoulder pain (SSP). Guidelines suggest exercise therapy for at least three months and research underlines the importance of progressive loaded exercise therapy at high dosage. However, it is not clear which is the best type of exercise and if pain should be provoked or avoided 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 is to investigate if one painful exercise can give better and faster results in the management of SSP than non-painful program.
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 (Participant, Investigator, Outcomes Assessor)
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
- •shoulder pain for at least 3 months, elicited in the anterolateral shoulder region
- •at least 3 out of 5 of the following tests positive: Neer test, Hawkins-Kennedy, Jobe, painful arc, external resistance test
- •resting pain should be at 2/10 maximum on verbal numerical pain rating scale (NPRS)
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
- •previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder
- •primary complaint of spinal pain or signs of central nervous system involvement or signs of cervical nerve root involvement; reproduction of shoulder pain with cervical rotation or axial compression
- •primary diagnosis of acromioclavicular pathology, shoulder instability
- •a radiologically confirmed fracture or previous medical imaging confirming the presence of calcification larger than 5 mm
- •presence of competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy, psychiatric illness, osteoporosis, hemophilia, rheumatic polymyalgia)
- •more than 4h of training in sport overhead shoulder activities per week
研究组 & 干预措施
exercising into pain
The participants will train during 12 with progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, including 2 in closed kinetic chain exercises and 2 executed with the elastic band or with dumbbell/weight. One exercise will be performed with pain ranging between 4 and 7 on a NPRS (Numeric Pain Rating Scale) and the rest of the exercises will be performed with no/slight pain, ranging between 0 and 2 on NPRS. At week 9, patients will continue to exercise with pain between 0 and 2 in all exercises. 10/15 minutes of manual therapy (posterior capsular release) will be applied during the physiotherapy session.
干预措施: exercising into pain (Other)
exercising with no/slight pain
The participants will train during 12 weeks with progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, including 2 in closed kinetic chain exercises and 2 executed with the elastic band or with dumbbell/weight. All the exercises will be performed with no/slight pain, ranging between 0 and 2 on NPRS. 10/15 minutes of manual therapy (posterior capsular release) will be applied during the physiotherapy session.
干预措施: exercising with no/slight pain (Other)
结局指标
主要结局
Shoulder Pain and Disability Index (SPADI)
时间窗: Change from baseline to 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
- Scapular Correction(Change from baseline to 6 months)
- Visual Analogue Scale (VAS)(Change from baseline to 6 months)
- Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption(Change from baseline to 6 months)
- Supraspinatus Tendon Thickness(Change from baseline to 6 months)
- Health-Related Quality of Life(Change from baseline to 6 months)
- Fear-Avoidance Beliefs Questionnaire (FABQ)(Change from baseline to 6 months)
- Scapular Dyskinesis(Change from baseline to 6 months)
- Acromiohumeral Distance(Change from baseline to 6 months)
- Fear of Pain Questionnaire (FPQ-9)(Change from baseline to 6 months)
- Range of Movement (ROM) in internal rotation, external rotation, scaption(Change from baseline to 6 months)
- Coracohumeral distance(Change from baseline to 6 months)
- Subscapularis Tendon Thickness(Change from baseline to 6 months)
- Shoulder Pain and Disability Index (SPADI)(Change from baseline to 6 months)
- Visual Analogue Scale (VAS)(Change from baseline to 12 weeks)
- Health-Related Quality of Life(Change from baseline to 12 weeks)
- Fear-Avoidance Beliefs Questionnaire (FABQ)(Change from baseline to 12 weeks)
- Fear of Pain Questionnaire (FPQ-9)(Change from baseline to 12 weeks)
- Range of Movement (ROM) in internal rotation, external rotation, scaption(Change from baseline to 12 weeks)
- Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption(Change from baseline to 12 weeks)
- Scapular Dyskinesis(Change from baseline to 12 weeks)
- Scapular Correction(Change from baseline to 12 weeks)
- Acromiohumeral Distance(Change from baseline to 12 weeks)
- Coracohumeral distance(Change from baseline to 12 weeks)
- Supraspinatus Tendon Thickness(Change from baseline to 12 weeks)
- Subscapularis Tendon Thickness(Change from baseline to 12 weeks)
研究者
Filip Struyf
Professor
Universiteit Antwerpen