The Effects of Additional Home-based Strengthening Exercises in Shoulder Impingement Rehabilitation (The SEXSI-Trial): A Pragmatic Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- SPADI
研究概览
简要总结
This study evaluates the addition of a high dose of simple home-based elastic band strengthening exercises to usual care in patients with subacromial impingement syndrome. Half of the participants receive instructions in simple home-based elastic band strengthening exercises in addition to usual care, while the other half receive usual care.
详细描述
The SEXSI trial is a pragmatic, assessor and participant blinded, randomized, controlled, superiority trial, with a two-group parallel design. Patients with subacromial impingement syndrome will be randomized to either usual care or a home-based intervention consisting of progressive high volume resistance training in addition to usual care using a 1:1 allocation. The primary end-point will be change in the Shoulder Pain and Disability Index (SPADI) 16 weeks after baseline.
The overall frame for the trial is a main clinical effectiveness-part and an embedded mechanistic part. The clinical effectiveness-part will be reported in the main trial paper, and include the following outcomes: SPADI (primary outcome), Abduction strength, External rotation strength, Abduction ROM, Pain last week, QoL-index, QoL-VAS, Global impression of change and PASS. Missing outcome data will be imputed using multiple imputations based on the following variables: All previous scores in the relevant outcome, Age, Gender and Allocation.
A full trial protocol will be published and made publicly available. A constrained Linear Mixed Model (cLMM) will be applied for all continuous outcomes with Time Frame 16 weeks (including the primary outcome), to compare the change from baseline to 16 weeks in the intervention group (IG) to that in the control group (CG). The outcome at 16 weeks will be included as dependent variable, treatment group (IG or CG) as main effect and both baseline score and any additional follow up measurements as repeated measurements. The covariance structures will be selected based on the MAICE procedure. Binary outcomes will be reported as proportions with corresponding 95% confidence intervals, and will be compared using Chi-squared tests, and Odds Ratios computed from random effects logistic regression models. All of these analyses will be conducted as intention to treat (ITT) analyses, including all randomized participants, regardless of protocol adherence, meaning that all participants will be analysed as randomized. In the primary trial report, all collected outcomes will be listed, and it will be stated that the below-mentioned variables - belonging to the mechanistic part - will be reported in secondary publications.
The mechanistic part will be reported in secondary papers with a clear reference to the primary trial and trial registration, and it will hold the label "secondary analyses from a pragmatic randomized controlled trial" in the title. The following outcomes will be reported:
Outcomes regarding pain sensitization (temporal summation of pain, conditioned pain modulation, pain pressure threshold and pain catastrophizing) will be reported in a subsequent paper where we also plan to investigate:
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
- Double (Participant, 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
- •Convened for the first time to the clinic, for examination of their current shoulder disorder
- •Shoulder disorder lasting at least three months
- •Living in Capitol Region of Denmark
- •Not pregnant
- •Do not permanently use strong pain medication
- •Able to understand spoken and written Danish
- •≥3 positive of the five diagnostic test for subacromial impingement syndrome (Hawkins-Kennedy test, Neer's test, pain-full arc, Resisted External Rotation test and Jobe's test)
- •Offered a rehabilitation plan due to a medically justified need for general rehabilitation after discharge from the hospital under the Danish Health Act §
- •Completed Shoulder Pain And Disability Index (SPADI) questionnaire on the day of the medical examination
排除标准
- •A radiologically verified new or previous fracture related to the shoulder joint, including the scapula
- •Clinically suspected Glenohumeral osteoarthritis
- •A clinically suspected luxation or sub-luxation of the glenohumeral, acromioclavicular or sternoclavicular joint
- •A clinically suspected labral lesion, complete tear of the rotator cuff, frozen shoulder or other competing diagnoses (i.e. rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, psychiatric illness)
结局指标
主要结局
SPADI
时间窗: 16 weeks
Shoulder Pain And Disability Index score (continuous) For all continuous outcomes with Time Frame 16 weeks, a constrained Linear Mixed Model (cLMM) is applied to compare the change from baseline to 16 weeks in the intervention group (IG) to that in the control group (CG), with the outcome at 16 weeks as dependent variable, treatment group (IG or CG) as main effect and both baseline score and any additional follow up measurements as repeated measurements. The covariance structures will be selected based on the MAICE procedure. These analyses will be conducted as intention to treat (ITT) analyses, including all randomized participants, regardless of protocol adherence. Participants will be analysed as randomized.
次要结局
- Abduction ROM(16 weeks)
- PPT-deltoid(16 weeks)
- Surgery(52 weeks)
- Abduction strength(16 weeks)
- Pain last week(16 weeks)
- QoL-index(52 weeks)
- PCS(16 weeks)
- CPM-Threshold(16 weeks)
- PPT-Supraspinatus(16 weeks)
- PPT-worst(16 weeks)
- External rotation strength(16 weeks)
- QoL-VAS(52 weeks)
- Temporal summation of pain (TS)(16 weeks)
- CPM-Detection(16 weeks)
- PPT-Infraspinatus(16 weeks)
- Sick leave(52 weeks)
- Global impression of change(16 weeks)
- SDT(16 weeks)
- mSAT(16 weeks)
- PASS(16 weeks)
- SPADI(52 weeks)
研究者
Mikkel Bek Clausen
PhD-Student
Copenhagen University Hospital, Hvidovre