Effectiveness of Surgery for Atraumatic Shoulder Instability

Atraumatic Shoulder Instability Clinical Trial

Official title:

Does Surgery Followed by Physiotherapy Improve Short and Long Term Outcomes for Patients With Atraumatic Shoulder Instability Compared With Physiotherapy Alone?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751490
• Other study ID #: 12.024
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: December 2022

Study information

• Verified date: April 2023
• Source: Royal National Orthopaedic Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atraumatic Shoulder Instability
• Joint Instability

Intervention

Other:
• physiotherapy
physiotherapy

Procedure:
• shoulder stabilisation surgery
arthroscopic stabilisation surgery

Locations

Country	Name	City	State
United Kingdom	Royal National Orthopaedic Hospital NHS Trust	Stanmore	Middlesex

Sponsors (2)

Lead Sponsor	Collaborator
Royal National Orthopaedic Hospital NHS Trust	University of Sydney

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Global perceived effect assessing participant-perceived improvement		over 24 months

External Links

•   Royal National Orthopaedics Hospital (RNOH) main website