Clinical trial NCT01751490: Effectiveness of Surgery for Atraumatic Shoulder Instability
Official title: Does Surgery Followed by Physiotherapy Improve Short and Long Term Outcomes for Patients With Atraumatic Shoulder Instability Compared With Physiotherapy Alone?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atraumatic Shoulder Instability
Keywords: shoulder
instability
atraumatic
Lead sponsor: Royal National Orthopaedic Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: University of Sydney
First posted: 2012-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain and functional impairment, measured using the Western Ontario Shoulder Instability Index.
timeFrame: over 24 months
Secondary outcomes:
measure: Global perceived effect assessing participant-perceived improvement
timeFrame: over 24 months
Other outcomes:
Locations:
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital NHS Trust
state: Middlesex
Study officials:
affiliation: Royal National Orthopaedic Hospital NHS Trust
name: Anju Jaggi, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal National Orthopaedic Hospital NHS Trust & UCL
name: Susan Alexander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Karen Ginn, BSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal National Orthopaedic Hospital NHS Trust
name: Andrew Symonds, BSc, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal National Orthopaedic Hospital NHS Trust
name: Suzie Cro, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaggi A, Alexander S, Herbert R, Funk L, Ginn KA. Does surgery followed by physiotherapy improve short and long term outcome for patients with atraumatic shoulder instability compared with physiotherapy alone? - protocol for a randomized controlled clinical trial. BMC Musculoskelet Disord. 2014 Dec 17;15:439. doi: 10.1186/1471-2474-15-439.