Effectiveness of Surgery for Atraumatic Shoulder Instability
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Atraumatic Shoulder Instability |
Other: physiotherapy Procedure: shoulder stabilisation surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Does Surgery Followed by Physiotherapy Improve Short and Long Term Outcomes for Patients With Atraumatic Shoulder Instability Compared With Physiotherapy Alone? |
- Change in pain and functional impairment, measured using the Western Ontario Shoulder Instability Index. [ Time Frame: over 24 months ] [ Designated as safety issue: No ]Looking at time points of baseline, 6 months, 12 months and 24 months
- Global perceived effect assessing participant-perceived improvement [ Time Frame: over 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 140 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: physiotherapy alone
patients undergoing physiotherapy only
|
Other: physiotherapy
physiotherapy
Procedure: shoulder stabilisation surgery
arthroscopic stabilisation surgery
Other Name: 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 Name: arthroscopic 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Iva Hauptmannova, BSc, MA | 0044(0)208909 5529 ext 5529 | research@rnoh.nhs.uk |
| Contact: Anju Jaggi, BSc | 0044(0)2089542300 ext 2300 | anju.jaggi@rnoh.nhs.uk |
| United Kingdom | |
| Royal National Orthopaedic Hospital NHS Trust | Not yet recruiting |
| Stanmore, Middlesex, United Kingdom, HA7 4LP | |
| Contact: Iva Hauptmannova, BSc, MA 0044(0)2086065529 research@rnoh.nhs.uk | |
| Contact: Anju Jaggi, BSc 0044(0)2089542300 anju.jaggi@rnoh.nhs.uk | |
| Principal Investigator: | Anju Jaggi, BSc | Royal National Orthopaedic Hospital NHS Trust |
| Principal Investigator: | Susan Alexander, MD | Royal National Orthopaedic Hospital NHS Trust & UCL |
| Principal Investigator: | Karen Ginn, BSc, PhD | The University of Sydney |
| Principal Investigator: | Andrew Symonds, BSc, MSc | Royal National Orthopaedic Hospital NHS Trust |
| Principal Investigator: | Suzie Cro, BSc | Royal National Orthopaedic Hospital NHS Trust |
More Information
Additional Information:
No publications provided
| Responsible Party: | Iva Hauptmannova, Sponsor representative, Royal National Orthopaedic Hospital NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01751490 History of Changes |
| Other Study ID Numbers: | 12.024 |
| Study First Received: | December 5, 2012 |
| Last Updated: | December 17, 2012 |
| Health Authority: | United Kingdom: Department of Health |
Keywords provided by Royal National Orthopaedic Hospital NHS Trust:
|
shoulder instability atraumatic |
ClinicalTrials.gov processed this record on May 19, 2013