Effectiveness of Surgery for Atraumatic Shoulder Instability

Not Applicable

Completed

• Conditions: Atraumatic Shoulder Instability
• Interventions: Other: physiotherapy; Procedure: shoulder stabilisation surgery

• Registration Number: NCT01751490
• Lead Sponsor: Royal National Orthopaedic Hospital NHS Trust

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-18
• Study Start: 2013-02
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
physiotherapy alone	physiotherapy	patients undergoing physiotherapy only
surgery and physiotherpay	physiotherapy	patients receiving surgical treatment followed by physiotherapy
surgery and physiotherpay	shoulder stabilisation surgery	patients receiving surgical treatment followed by physiotherapy
physiotherapy alone	shoulder stabilisation surgery	patients undergoing physiotherapy only

Primary Outcome Measures

Name	Time	Method
Change in pain and functional impairment, measured using the Western Ontario Shoulder Instability Index.	over 24 months	Looking at time points of baseline, 6 months, 12 months and 24 months

Secondary Outcome Measures

Name	Time	Method
Global perceived effect assessing participant-perceived improvement	over 24 months

Trial Locations

Locations (1)

Royal National Orthopaedic Hospital NHS Trust; 🇬🇧 Stanmore, Middlesex, United Kingdom