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?

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.

Study Overview

• Status: Completed
• Conditions: Atraumatic Shoulder Instability
• Intervention / Treatment: Other: physiotherapy; Procedure: shoulder stabilisation surgery

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iva Hauptmannova, BSc, MA; Phone Number: 5529 0044(0)208909 5529; Email: research@rnoh.nhs.uk
• Study Contact Backup: Name: Anju Jaggi, BSc; Phone Number: 2300 0044(0)2089542300; Email: anju.jaggi@rnoh.nhs.uk

Study Locations

• United Kingdom
  • Middlesex
    • Stanmore, Middlesex, United Kingdom, HA7 4LP
      • Royal National Orthopaedic Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: physiotherapy alone; patients undergoing physiotherapy only	Other: physiotherapy; physiotherapy; Procedure: shoulder stabilisation surgery; arthroscopic stabilisation surgery; Other Names: arthroscopic stabilisation surgery
Active Comparator: surgery and physiotherpay; patients receiving surgical treatment followed by physiotherapy	Other: physiotherapy; physiotherapy; Procedure: shoulder stabilisation surgery; arthroscopic stabilisation surgery; Other Names: arthroscopic stabilisation surgery

What is the study measuring?

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	Time Frame
Global perceived effect assessing participant-perceived improvement	over 24 months

Collaborators and Investigators

• Sponsor: Royal National Orthopaedic Hospital NHS Trust
• Collaborators: University of Sydney

Publications and helpful links

General Publications

• 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.

Helpful Links

• Royal National Orthopaedics Hospital (RNOH) main website

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: December 5, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (Estimate): December 18, 2012

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: instability; shoulder; atraumatic
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Joint Instability
• Other Study ID Numbers: 12.024