Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Shoulder Instability Return to Sport Index (SIRSI)
研究概览
简要总结
This study will compare functional outcomes after an arthroscopic Bankart repair between patients that underwent conventional arthroscopic Bankart repair rehabilitation, following the American Society of Shoulder and Elbow Therapists guideline and patients that underwent 'multifactorial approach training', which focusses on decreasing kinesiophobia and fear of recurrent dislocations.
The study population comprises patients who will undergo Arthroscopic Bankart Repair (ABR) after a traumatic anterior shoulder dislocation at Spaarne Gasthuis Haarlem/Hoofddorp, OLVG Amsterdam, Amstelland Ziekenhuis Amstelveen, Gelre Ziekenhuizen, Medisch Spectrum Twente, or Flevoziekenhuis Almere.
详细描述
Background: Fear for (recurrent) dislocation is a frequently reported patient perception regarding the treatment of anterior shoulder instability and is associated with poor outcomes like decrease in quality of life and unsuccesful return to sport. There is lack of standard multifactorial aftercare of shoulder instability surgery incorporating the psychological component of the experiences trauma of patients with shoulder instability. Therefore, a newly developed Rehabilitation Protocol (REPRO) aims to reduce fear for dislocation in order to increase psychological readiness to return to sport. The aim of this study is to compare the effect on the psychological readiness to return to sport between our new Multifactorial Approach Training (MAT) and Conventional Arthroscopic Bankart Repair Rehabilitation (CABRR) in a single-blinded, multi-center randomized controlled trial.
Methods: Patients, aged 18-67 years, with traumatic anterior shoulder instability, undergoing ABR will be included. Rehabilitation is started within 4 weeks following surgical treatment. Patients will be randomized to either the control group (A) or the MAT group (B). Group A will receive CABRR, according to the American Society of Shoulder and Elbow Therapists (ASSET) guidelines. Group B will receive MAT, following the REPRO. A total of 92 patients will be included, with 46 patients per study arm. Patients will be followed-up for 52 weeks. The primary outcome is change from baseline (surgical intervention; ABR) in Shoulder Instability Return to Sport Index (SIRSI) at 26 weeks postoperatively. Secondary outcomes include Oxford Shoulder Instability Score (OSIS), Subjective Shoulder Value (SSV), fear for dislocation measured with a Numeric Rating Scale (NRS), Tampa Scale of Kinesiophobia in patients with Shoulder Instability (TSK-SI), World Health Organization Quality of Life Questionnaire - BREF (WHOQoL-BREF), Return To Work (RTW), Return To Sports (RTS), shoulder pain measured with a NRS, , number of physiotherapy and outpatient clinic visits and patient satisfaction (VAS). At baseline and at 26 weeks postoperatively patients will undergo a task-based brain activity analysis using functional Magnetic Resonance Imaging (fMRI) to determine functional cerebral changes after treatment. The MATASI trial is to be conducted between 2024 and 2026.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or recurrent traumatic anterior shoulder dislocation (MRI-confirmed labral tear)
- •Aged between 18-67 years
- •Planned arthroscopic Bankart repair (ABR) surgery
- •Understanding of spoken and written Dutch language
- •Written informed consent (according to the ICH-GCP guidelines)
- •Positive apprehension sign at physical examination
排除标准
- •Posterior or multidirectional shoulder instability
- •Presence of hyperlaxity of the upper extremity and absence of sulcus sign and >85 degrees of external rotation with the arm at the side at physical examination
- •Connective tissue disorders (e.g. Ehlers-Danlos)
- •Aged <18 or >67 years
- •Assymetry in rotator cuff strength, bilateral component ((sub)luxations on contralateral side)
- •History of soft tissue repair or bone block procedure on one of both shoulders
- •Current or past anxiety disorders or use of anxiety supressing drugs (e.g. anti-psychotics)
- •Implantable cardioverter defibrillator (ICD) (unable to be included for functional MRI)
- •Neurological disorders or systemic disease
- •Loss of anteroinferior sclerotic contour of the glenoid on AP view of the shoulder
- •Hill-Sachs lesion visible on external rotation radiographs
- •Greater tubercle fracture
结局指标
主要结局
Shoulder Instability Return to Sport Index (SIRSI)
时间窗: 26 weeks postoperative
Patient reported outcome measure to assess psychological readiness to return to sport in patients with shoulder instability
次要结局
- The number of physiotherapy and orthopedic surgeon visits(From start to end of treatment)
- Level of shoulder pain measured by Visual Analogue Scale (VAS)(baseline, 26 and 52 weeks postoperative)
- Shoulder function, measured by Subjective Shoulder value (SSV)(baseline, 26 and 52 weeks postoperative)
- Tampa Scale for Kinesiophobia in patients with Shoulder Instability (TSK-SI)(baseline, 26 and 52 weeks postoperative)
- Number of patients that return to work (RTW) following the surgery(26 and 52 weeks postoperative)
- Oxford Shoulder Instability Score (OSIS)(26 and 52 weeks postoperative)
- Fear of recurrent dislocation, measured by Numeric Rating Scale (NRS)(baseline, 26 and 52 weeks postoperative)
- World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF)(baseline, 26 and 52 weeks postoperative)
- Number of patients tha return to sport (RTS) following the surgery(26 and 52 weeks postoperative)
- Task-based brain activity, measured in voxels(baseline and 26 weeks postoperative)
- Patient satisfaction regarding the surgical treatment and rehabilitation, measured by VAS(baseline, 26 weeks and 52 weeks postoperative)