Shoulder Exercises in Patients With Hypermobility Spectrum Disorder and Long-lasting Shoulder Symptoms: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Change in Western Ontario Shoulder Instability Index (WOSI) questionnaire total score
研究概览
简要总结
Hypermobility Spectrum Disorder (HSD) is a recent diagnosis that covers generalised joint hypermobility with one or more secondary symptomatic musculoskeletal manifestations. Current clinical management of this population with shoulder symptoms is based on limited evidence and includes a combination of non-specific physiotherapy modalities and exercise prescription. There is some evidence suggesting that strength training may be valuable for treatment of this patient-group. Therefore, the aim of this study is to evaluate the effectiveness of a heavy shoulder strengthening exercise programme in patients with HSD and shoulder symptoms.
详细描述
Hypermobility Spectrum Disorder (HSD) is a recent diagnosis that covers generalised joint hypermobility with one or more secondary symptomatic musculoskeletal manifestations such as chronic shoulder pain and shoulder instability. The evidence for treatment is sparse, but current clinical management of this patient-group with persistent shoulder symptoms is a combination of non-specific physiotherapy modalities and exercise prescription. There is some evidence suggesting that strength training may be valuable for treatment of this patient-group. The intervention consisting of heavy shoulder strengthening exercises has recently been tested to be feasible, and since clinical improvements were seen, the intervention is ready to be studied in a randomised controlled trial. Therefore, the aim of this study is to evaluate the effectiveness of a heavy shoulder strengthening exercise programme and general advice as compared to shoulder stability exercises and general advice (current standard care) in patients with HSD and persistent shoulder symptoms. The primary hypothesis is that a heavy shoulder strengthening exercise programme is superior to standard care.
Sample size considerations: a clinically significant effect of 252 points or more out of 2100 points (SD = 350 points) between the two groups over the 16 weeks is desired, which with a two-sided significance of 0.05, a power of 0.9, and 16% dropout, requires a total of 100 patients. In case 100 patients are not included within 24 months, a stopping rule will be applied as soon as at least 76 patients are included, corresponding to a power of minimum 0.8.
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 (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
- •Men and women aged 18 - 65
- •Generalized HSD (G-HSD) defined with Beighton score cut-off ≥ 5 for women up to the age of 50 years and ≥ 4 for those above 50 years and all men, or Historical HSD (H-HSD) if the Beighton score was 1 point below the age and sex-specific cut-off AND the five-part questionnaire (5PQ) was positive (= at least two positive items).
- •Present with one or more secondary symptomatic musculoskeletal manifestations, defined as either
- •musculoskeletal pain in minimum one shoulder for at least three months
- •recurrent joint dislocations or joint instability without a reported history of trauma defined as either a) minimum three atraumatic dislocations in same shoulder, b) minimum two atraumatic dislocations in two different joints (minimum one in the shoulder) occurring at different times, or c) medical confirmation of joint instability in minimum two joints (minimum one in the shoulder) not related to trauma.
排除标准
- •Clinically suspected referred pain from the cervical spine
- •Systemic inflammatory rheumatic diseases
- •Connective tissue diseases (e.g. Marfans, Stickler's or Loeys Dietz syndromes, Ehlers-Danlos Syndromes except hypermobile type)
- •Neurological diseases
- •Pregnancy or childbirth within the past year or planning to get pregnant during the study period
- •Shoulder surgery within the past year
- •Steroid injection in the affected shoulder within three months
- •Inability to speak and understand Danish.
- •Unable to comply with protocol
研究组 & 干预措施
Shoulder strengthening exercises
Progressive heavy shoulder strengthening exercises three times weekly and advice on load and pain management. Exercise sessions are supervised twice a week corresponding to 32 supervised exercise sessions during the 16 weeks.
干预措施: Exercise (Other)
Shoulder stability exercises
Recommendations of shoulder stability exercises which are to be performed unsupervised (e.g. at home) three times weekly and advice on load and pain management. Three supervised sessions are offered during the 16 weeks, and exercises are primarily performed unsupervised at home.
干预措施: Exercise (Other)
结局指标
主要结局
Change in Western Ontario Shoulder Instability Index (WOSI) questionnaire total score
时间窗: 16 weeks
Western Ontario Stability Index questionnaire (WOSI) is a tool designed for self-assessment of shoulder function for patients with instability problems. This questionnaire has 21 questions, each scored on a scale from 0 to 100, with 0 being the best score (no limitations related to the shoulder) and 100 representing the worst score. Overall, the questionnaire is scored from 0-2100 points (better to worse). There are subscale components reporting on: physical symptoms (questions 1 through 10; maximum score of 1000); sports/recreation/work (questions 11 through 14; maximum score 400); lifestyle (questions 15 through 18; maximum score 400); and emotion (questions 19-21; maximum score 300). Subscale scores are added to determine the total score out of a possible 2100 points, with 2100 representing the worst possible score.
次要结局
- Change in pain level on numeric pain rating scale(12 months.)
- Change in symptom level on numeric rating scale(12 months.)
- Change in Checklist Individual Strength (CIS), fatigue subscale(12 months.)
- Change in Dartmouth Primary Care Cooperative Research Network/World Organization of National Colleges, Academies and Academic Associations of General Practitioners/Family Physicians (COOP/WONCA)(12 months.)
- Change in Tampa Scale of Kinesiophobia (TSK-11)(12 months.)
- Change in EuroQol 5 dimension 5 level (EQ-5D-5L)(12 months.)
- Change in isometric shoulder strength(16 weeks.)
- Change in active and passive shoulder range of motion(16 weeks)
- Change in shoulder proprioception(16 weeks)
- Change in Patient Specific Functional Scale (PSFS)(12 months.)
- Change in clinical shoulder tests(16 weeks.)
- Adverse events(12 months.)
- Change in subscales of the Western Ontario Shoulder Instability Index (WOSI) questionnaire(12 months.)
- Physical Activity(Baseline)
- Global Perceived Effect (GPE)(16 weeks)
- Compliance with exercise(16 weeks)
- Demographic(Baseline)
- Anthropometrics(Baseline and 16 weeks)
研究者
Behnam Liaghat
Principal Investigator
University of Southern Denmark