Shoulder dislocation Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Participants deemed eligible to take part in the trial, according to the protocol will be approached to be invited to the study. After time to consider, written informed consent will be obtained. Part
Oxford Shoulder Instability Score (OSIS), QuickDASH, and EQ5D-5L. Referral to a physiotherapist will be made at this stage. Eligibility will then be re-checked and participants will be requested to c
Sponsors
University Hospitals Coventry and Warwickshire NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. Aged 18 years or over 3. Patients have a primary traumatic acute shoulder dislocation, confirmed by radiology
Exclusion criteria
Exclusion criteria: 1. Bilateral shoulder dislocation 2. Having first-line surgical treatment (Indications include a displaced greater tuberosity fracture for example) 3. Cannot receive first session of physiotherapy within 6 weeks of injury 4. In the opinion of the assessing clinician there is a neurovascular complication associated with TASD 5. Unable to adhere to trial procedures or complete questionnaires; for example, a history of permanent cognitive impairment 6. Previous randomisation in the present trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxford Shoulder Instability Score (OSIS): The OSIS is a self-completed outcome measure containing 12 questions (0-4 points each), with possible scores from 0 (best function) to 48 (worst function) (8, 11). These questions relate to activities of daily living particularly relevant to patients exhibiting shoulder instability. The OSIS has been specifically designed to assess outcome of therapy (both surgical and non-surgical) by measuring activities of daily living and pain of patients exhibiting shoulder instability. Measured at 6 months after injury. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at 6 weeks, 3, 6 and 12 months after taking part in the study: 1. QuickDASH: The QuickDASH is a self-completed shortened version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The questionnaire was designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time 2. EQ-5D-5L: Is a well validated, generic health-related quality of life measure consisting of five dimensions each with 5-levels of response. Each combination of answers can be converted into a health utility score. It has good test-retest reliability, is simple for participants to use, and gives a single preference based index value for health status that can be used for broader cost-effectiveness comparative purposes 3. Complications: Complications will be reported through the following mechanisms: a) Participant reported during routine collection of follow up data; b) Local research teams will report any additional investigations or treatment of participants c) Local physiotherapists delivering the trial interventions will report any events occurring during treatment sessions d) Medical records of non-responding participants may be retrieved by local research teams at site. Complications will be defined into three categories: a) Pre-defined complications directly related to the trial interventions b) Pre-defined complications directly caused by the primary TASD event not identified by the initial assessing clinician, but subsequently identified c) Complications not related to the intervention or TASD event and will subsequently not be formally analysed or reported 4. Resource use questionnaires: The primary health-economic analysis will concentrate on direct intervention and healthcare/personal social services costs, whil | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed