NCT01751490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 18, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

9.8 years

First QC Date

December 5, 2012

Last Update Submit

April 24, 2023

Conditions

Atraumatic Shoulder Instability

Keywords

shoulderinstabilityatraumatic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Global perceived effect assessing participant-perceived improvement

    over 24 months

Study Arms (2)

physiotherapy alone

ACTIVE COMPARATOR

patients undergoing physiotherapy only

Other: physiotherapyProcedure: shoulder stabilisation surgery

surgery and physiotherpay

ACTIVE COMPARATOR

patients receiving surgical treatment followed by physiotherapy

Other: physiotherapyProcedure: shoulder stabilisation surgery

Interventions

physiotherapyOTHER

physiotherapy

physiotherapy alonesurgery and physiotherpay
shoulder stabilisation surgeryPROCEDURE

arthroscopic stabilisation surgery

Also known as: arthroscopic stabilisation surgery
physiotherapy alonesurgery and physiotherpay

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • feelings of insecurity (apprehension) at their shoulder joint
  • provocation of apprehension with drawer and apprehension tests
  • evidence labral/capsular injury in the shoulder joint

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal National Orthopaedic Hospital NHS Trust

Stanmore, Middlesex, HA7 4LP, United Kingdom

Location

Related Publications (2)

  • Jaggi A, Herbert RD, Alexander S, Majed A, Butt D, Higgs D, Rudge W, Ginn KA. Arthroscopic capsular shift surgery in patients with atraumatic shoulder joint instability: a randomised, placebo-controlled trial. Br J Sports Med. 2023 Dec;57(23):1484-1489. doi: 10.1136/bjsports-2022-106596. Epub 2023 Jun 12.

    PMID: 37308285DERIVED

  • 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.

    PMID: 25515666DERIVED

Related Links

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • 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

    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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sponsor representative

Study Record Dates

First Submitted

December 5, 2012

First Posted

December 18, 2012

Study Start

February 1, 2013

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

GB(1)