Effectiveness of Surgery for Atraumatic Shoulder Instability

Study Overview
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Brief Summary
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We will conduct a randomised clinical trial with the primary aim of determining whether surgical intervention followed by physiotherapy rehabilitation improves pain and disability outcomes more than physiotherapy rehabilitation alone in patients suffering from atraumatic shoulder instability associated with bony/capsulolabral damage. The results of this study will have direct and immediate impact on clinical decision making by establishing definitively if patients presenting with joint damage associated with atraumatic shoulder instability should be referred for surgery before commencing physiotherapy rehabilitation. The results of this study may also result in significant cost savings to the National Health Service if surgical intervention for atraumatic shoulder instability does not result in greater improvement than physiotherapy alone.

Detailed Description
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A two-arm, patient, physiotherapist and assessor-blinded, randomised controlled clinical trial will be conducted. 140 patients will be randomly allocated into one of 2 groups: a stabilisation surgery group and a control group. Primary outcomes (pain and disability) and secondary outcomes (participant-reported improvement and incidence of shoulder dislocations) will be evaluated at baseline and 6, 12 and 24 months after randomisation. Additional secondary outcomes of shoulder rotation range of motion and strength will be evaluated 6 months after randomisation.

Official Title
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Does Surgery Followed by Physiotherapy Improve Short and Long Term Outcomes for Patients With Atraumatic Shoulder Instability Compared With Physiotherapy Alone?

Conditions
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Atraumatic Shoulder Instability

Intervention / Treatment
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* Other: physiotherapy
* Procedure: shoulder stabilisation surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: feelings of insecurity (apprehension) at their shoulder joint provocation of apprehension with drawer and apprehension tests evidence labral/capsular injury in the shoulder joint Exclusion Criteria: a history of a high collision shoulder injury precipitating apprehension symptoms evidence of bony injury around glenoid rim/and or humeral head a pristine joint i.e. no evidence of any structural injury to the joint, capsule or labrum. a rotator cuff tear neural damage affecting the upper limb previous shoulder surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: physiotherapy alone<br>patients undergoing physiotherapy only | Other: physiotherapy<br>* physiotherapy<br>Procedure: shoulder stabilisation surgery<br>* arthroscopic stabilisation surgery<br>* Other names: arthroscopic stabilisation surgery;|
| Active Comparator: surgery and physiotherpay<br>patients receiving surgical treatment followed by physiotherapy | Other: physiotherapy<br>* physiotherapy<br>Procedure: shoulder stabilisation surgery<br>* arthroscopic stabilisation surgery<br>* Other names: arthroscopic stabilisation surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain and functional impairment, measured using the Western Ontario Shoulder Instability Index. | Looking at time points of baseline, 6 months, 12 months and 24 months | over 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global perceived effect assessing participant-perceived improvement |  | over 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder, instability, atraumatic