Get them moving early: sling immobilisation following arthroscopic anterior shoulder stabilisation offers no advantage
| ISRCTN | ISRCTN13628010 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13628010 |
| Secondary identifying numbers | 10/S0802/39 |
- Submission date
- 07/08/2017
- Registration date
- 10/08/2017
- Last edited
- 02/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Arthroscopic shoulder stabilisation is a commonly performed operation to treat recurrent dislocation of the shoulder. There is lack of agreement about rehabilitation after arthroscopic shoulder stabilisation surgery, with most surgeons recommending immobilisation of the shoulder for three to six weeks after surgery to allow the ligaments to heal and prevent recurrence. However, one of the risks of prolonged immobilisation is residual shoulder stiffness. Advocates of early mobilisation argue that there is no apparent increased risk of recurrence and excess stiffness is avoided. It also permits early strengthening and exercises. The aim of this study is to assess the recurrence rate and shoulder function of patients after arthroscopic stabilisation of the shoulder with two different rehabilitation regimes.
Who can participate?
Patients with recurrent shoulder instability undergoing arthroscopic anterior shoulder stabilisation
What does the study involve?
On the day of surgery, participants are randomly allocated to either the early mobilisation (EM) or sling immobilisation (SI) group. The EM group is immediately allowed to move the shoulder freely as pain allows. The SI Group is kept in a sling for 6 weeks. All participants are followed up at 6 weeks, 3, 6, 12 and 24 months to assess their shoulder function and to find out whether the surgery has worked or not.
What are the possible benefits and risks of participating?
The results will show which rehabilitation programme is best for patients undergoing arthroscopic shoulder stabilisation surgery. Possible benefits of early mobilisation include reduced risk of stiffness and increased proprioception (the body's ability to sense joint movement and position). The risk of early mobilisation is the theoretical risk of the surgical repair failing.
Where is the study run from?
Woodend General Hospital (UK)
When is the study starting and how long is it expected to run for?
August 2010 to August 2015
Who is funding the study?
NHS Grampian R&D (UK)
Who is the main contact?
Mr Sriskandarasa Senthilkumaran
Contact information
Scientific
Department of Orthopaedics
Woodend General Hospital
Eday Road
Aberdeen
AB15 6XS
United Kingdom
 ORCID ID |
0000-0002-7043-5339 |
|---|
Study information
| Study design | Single-centre single-blind randomised control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Randomised control study to compare sling immobilisation with early mobilisation in patients undergoing arthroscopic anterior shoulder stabilisation surgery |
| Study objectives | There should be no difference in the recurrence rate and shoulder function between the sling immobilisation and early mobilisation groups. |
| Ethics approval(s) | NHS Grampian R&D, 30/06/2010, ref: 10/S0802/39 |
| Health condition(s) or problem(s) studied | Arthroscopic anterior shoulder stabilisation for instability |
| Intervention | On the day of surgery, participants were randomised using sealed envelopes to either early mobilisation (EM) or sling immobilisation (SI) group. The EM group was allowed to move the shoulder freely as pain allowed immediately. The SI Group was kept in a sling for 6 weeks. All patients were followed up at 6 weeks, 3, 6, 12 and 24 months. Their function and failure of surgery were assessed using Oxford Shoulder Instability Score (OSIS). |
| Intervention type | Other |
| Primary outcome measure | Failure of surgery, defined as subluxation or redislocation at 6 weeks, 3 months, 6 months, 12 months and 24 months |
| Secondary outcome measures | Shoulder instability, assessed using the Oxford Shoulder Instability Score at pre-op, 6 weeks, 3 months, 6 months, 12 months and 24 months |
| Overall study start date | 01/08/2010 |
| Completion date | 30/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 but stopped after 28 |
| Key inclusion criteria | 1. Patients with recurrent instability who had a Bankart lesion 2. Deemed suitable clinically and radiologically for an arthroscopic anterior shoulder stabilisation 3. No restriction on age |
| Key exclusion criteria | 1. Patients with previous failed stabilisation, multi-directional instability or posterior instability 2. Patients who were unwilling to participate |
| Date of first enrolment | 25/08/2010 |
| Date of final enrolment | 10/07/2013 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Aberdeen
AB15 6XS
United Kingdom
Sponsor information
Hospital/treatment centre
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
Scotland
United Kingdom
"ROR" |
https://ror.org/00ma0mg56 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The trialists are hoping to submit the study to a journal as soon as it is registered. |
| IPD sharing plan | The anonymised dataset will be available for review but not for sharing with other institutions as consent was not obtained for this. The data is kept by Mr Sriskandarasa Senthilkumaran and Mr Kapil Kumar (principal investigator for the study). Consent from participants was obtained for analysis. |
Editorial Notes
02/12/2019: The intention to publish date has been changed from 08/11/2017 to 30/06/2020.
26/11/2019: No publications found, verifying study status with principal investigator.
