Effectiveness of Surgery for Atraumatic Shoulder Instability

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01751490

Enrollment

Registered

2012-12-18

Start date

2013-02-28

Completion date

2022-12-31

Last updated

2023-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atraumatic Shoulder Instability

Keywords

shoulder, instability, atraumatic

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.

Interventions

OTHERphysiotherapy

physiotherapy

PROCEDUREshoulder stabilisation surgery

arthroscopic stabilisation surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Global perceived effect assessing participant-perceived improvement	over 24 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026