Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Sydney | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| physiotherapy alone | Active Comparator | patients undergoing physiotherapy only |
|
| surgery and physiotherpay | Active Comparator | patients receiving surgical treatment followed by physiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physiotherapy | Other | physiotherapy |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Global perceived effect assessing participant-perceived improvement | over 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal National Orthopaedic Hospital NHS Trust | Stanmore | Middlesex | HA7 4LP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37308285 | Derived | 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. | |
| 25515666 | Derived |
| Label | URL |
|---|---|
| Royal National Orthopaedics Hospital (RNOH) main website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| shoulder stabilisation surgery |
| Procedure |
arthroscopic stabilisation surgery |
|
|
| 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. |