Royal National Orthopaedic Hospital NHS Trust
Stanmore, Middlesex, HA7 4LP, United Kingdom
Completed
NCT Number: NCT01751490
Effectiveness of Surgery for Atraumatic Shoulder Instability
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Physiotherapy
Otherphysiotherapy
shoulder stabilisation surgery
Procedurearthroscopic stabilisation surgery
Other names: arthroscopic stabilisation surgery
Primary outcomes
-
Change in pain and functional impairment, measured using the Western Ontario Shoulder Instability Index.
Time frame: over 24 months
Looking at time points of baseline, 6 months, 12 months and 24 months
Secondary outcomes
-
Global perceived effect assessing participant-perceived improvement
Time frame: over 24 months
Sponsors and collaborators
Lead sponsor
Royal National Orthopaedic Hospital NHS Trust
Other
Collaborators
- University of Sydney
Registry information
Official study title
Does Surgery Followed by Physiotherapy Improve Short and Long Term Outcomes for Patients With Atraumatic Shoulder Instability Compared With Physiotherapy Alone?
Important dates
- Study start
- 2013
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Dec 18, 2012
- Registry last updated
- Apr 25, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.