Effectiveness of Surgery for Atraumatic Shoulder Instability
Primary Purpose
Atraumatic Shoulder Instability
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
physiotherapy
shoulder stabilisation surgery
Sponsored by
About this trial
This is an interventional treatment trial for Atraumatic Shoulder Instability focused on measuring shoulder, instability, atraumatic
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
Sites / Locations
- Royal National Orthopaedic Hospital NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
physiotherapy alone
surgery and physiotherpay
Arm Description
patients undergoing physiotherapy only
patients receiving surgical treatment followed by physiotherapy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Global perceived effect assessing participant-perceived improvement
Full Information
NCT ID
NCT01751490
First Posted
December 5, 2012
Last Updated
April 24, 2023
Sponsor
Royal National Orthopaedic Hospital NHS Trust
Collaborators
University of Sydney
1. Study Identification
Unique Protocol Identification Number
NCT01751490
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2022 (Actual)
Study Completion Date
December 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal National Orthopaedic Hospital NHS Trust
Collaborators
University of Sydney
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atraumatic Shoulder Instability
Keywords
shoulder, instability, atraumatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
physiotherapy alone
Arm Type
Active Comparator
Arm Description
patients undergoing physiotherapy only
Arm Title
surgery and physiotherpay
Arm Type
Active Comparator
Arm Description
patients receiving surgical treatment followed by physiotherapy
Intervention Type
Other
Intervention Name(s)
physiotherapy
Intervention Description
physiotherapy
Intervention Type
Procedure
Intervention Name(s)
shoulder stabilisation surgery
Other Intervention Name(s)
arthroscopic stabilisation surgery
Intervention Description
arthroscopic stabilisation surgery
Primary Outcome Measure Information:
Title
Change in pain and functional impairment, measured using the Western Ontario Shoulder Instability Index.
Description
Looking at time points of baseline, 6 months, 12 months and 24 months
Time Frame
over 24 months
Secondary Outcome Measure Information:
Title
Global perceived effect assessing participant-perceived improvement
Time Frame
over 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anju Jaggi, BSc
Organizational Affiliation
Royal National Orthopaedic Hospital NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Alexander, MD
Organizational Affiliation
Royal National Orthopaedic Hospital NHS Trust & UCL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Ginn, BSc, PhD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Symonds, BSc, MSc
Organizational Affiliation
Royal National Orthopaedic Hospital NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suzie Cro, BSc
Organizational Affiliation
Royal National Orthopaedic Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal National Orthopaedic Hospital NHS Trust
City
Stanmore
State/Province
Middlesex
ZIP/Postal Code
HA7 4LP
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25515666
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.
Results Reference
derived
Links:
URL
http://www.rnoh.nhs.uk/
Description
Royal National Orthopaedics Hospital (RNOH) main website
Learn more about this trial
Effectiveness of Surgery for Atraumatic Shoulder Instability
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