Background
The shoulder is the most frequently dislocated joint; dislocation occurs in 8.2–23.9 per 100,000 people per year, and 95% of these are anterior dislocations.1 They occur when excessive forces during a traumatic event displace the humeral head frontwards, out of the shoulder socket (glenoid fossa), resulting in the joint surfaces completely losing contact.1–3
Traumatic anterior shoulder dislocation (TASD) predominantly affects males under 25 years during high-impact incidents and females over 80 years during low-impact incidents. This is an increasing health problem in this group because of our ageing population.1
Regardless of their age, people sustaining TASD may have ongoing pain, disability and substantial morbidity linked to high recurrence rates and subsequent need for repeated episodes of management.1–3 Re-dislocation following a first-time traumatic event typically occurs within 12 months of the index dislocation.4 Common reasons leading to re-dislocation include soft-tissue damage surrounding the shoulder, such as a Bankart lesion in which there is damage to the glenoid rim, and bony injuries such as Hill–Sachs lesions whereby the humeral head sustains a compression fracture during the index event.5,6
Rehabilitation may reduce ongoing re-dislocations and restore a functional, painless and stable shoulder through early restoration of joint movement and promotion of exercises to retrain muscles to maintain stability.2 However, prior to the start of this trial a 2014 Cochrane review did not find an evidence base to support this.2 Dutch national guidelines explicitly state no referral to physiotherapy should be made,3 while UK guidelines state that referral ‘may be helpful’.1 Thus, the nature and extent of physiotherapy required for the management of patients following TASD are unclear.
A typical course of six physiotherapy sessions costs around £378; a single assessment and advice session costs £63 (lead centre costs). Hence, the choice of physiotherapy package after TASD has large resource implications for the NHS. Assuming, conservatively, an incidence of 10/100,000 of first TASD, by 2020 there will be around 67,000 TASDs annually treated by the NHS.
In addition to the cost of providing physiotherapy services, there was a clear message from our patient workshop that attending a typical course of six sessions of physiotherapy is burdensome. Younger people may need to take time from work or arrange care for dependents, while older people may find travel challenging, particularly if unable to drive following the dislocation. For both groups this can be time-consuming and costly. If a single advice session were all that is required, it would have a positive impact on patient experience after TASD, lessening the burden on patients and their friends and families.
Consequently, a course of supervised, tailored physiotherapy needs to be of clear additional benefit, when compared to a single session and an advice leaflet, if it is to be implemented as standard care in the NHS. There is no clinical consensus or high-quality evidence on how best to manage TASDs.1 With increasing numbers, because of an ageing population and the need to remain active in older age through continued participation in sporting activities, there is a need for evidence regarding the nature and extent of what physiotherapy is required for the management of patients following TASD.
Existing knowledge
Joint British Elbow and Shoulder Society (BESS) and British Orthopaedic Association (BOA) guidelines, and two Cochrane reviews, advocate non-operative management for people with a first TASD who are aged 25 years or over and suggest further research on the possible benefits of surgery in those under 25.1,2,7 Despite non-operative care being the predominant first-line strategy, at the start of this study there was no randomised controlled trial (RCT) evidence regarding what to do once the decision not to operate has been made.1–3 A 2014 Cochrane review on methods of non-operative management concluded that there were no published RCTs comparing rehabilitation methods after the initial 2 weeks of immobilisation.2 The review also found no evidence of any ongoing studies.1–3
With more people receiving first-line non-operative management, combined with the large personal and societal cost associated with this injury, the evidence gap in rehabilitation was a clear priority. Crucially, we needed to know whether resourcing an intensive physiotherapy package was clearly superior to a single advice session.
An updated review in 2019 identified one ongoing study, in addition to this study, that has since completed (n = 56).8,9 The researchers randomised 56 participants, across three orthopaedic shoulder units in Denmark, to either a home-based exercise intervention or a supervised 12-week intervention, led and supervised by a physiotherapist. No further ongoing studies were identified in an updated search of trial registries.
Intervention development
The Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN) trial intervention was developed following the Medical Research Council (MRC) guidance for developing and evaluating complex interventions.10 Using an iterative process, based on research evidence, clinical guidelines, current practice, clinicians’ and patients’ opinions, we developed a rehabilitation intervention following a TASD. The intervention had four phases: (1) education, (2) range of movement exercises, (3) strengthening exercises and (4) returning to sports. We developed an intervention manual for physiotherapists, and patient materials consisting of paper booklets and web-based materials.
Our aim was to ensure that the single-session ARTISAN intervention was scientifically grounded, acceptable to patients and clinicians, and deliverable in the UK NHS setting.
Clinical guidelines
In the UK, the BESS and the BOA published joint guidelines advocating conservative management for TASD for those aged 25 years and over, alongside early referral to physiotherapy.1 They did not make any recommendations regarding the content of rehabilitation. Outside of the UK, only one further set of national guidelines was identified. Dutch Orthopaedic Association guidelines state that physiotherapy is not recommended after a TASD.3
Literature review of best practice prior to trial
We obtained full papers included in a second Cochrane review entitled ‘Surgical versus non-surgical treatment for acute anterior shoulder dislocation’.7 The aim was to collate and summarise rehabilitation protocols following conservatively managed TASD from these RCTs. However, rehabilitation protocols were either absent from the research papers or not sufficiently detailed to replicate.
Within the limited literature identified, there was a consensus on a phased approach to rehabilitation based on the underlying mechanism of injury and recovery timescales: beginning with simple range of movement exercises and progressing to strengthening exercises that are manipulated to be easier or more challenging by altering load, frequency and repetitions.
Consultation and national survey of practice
A synthesis of clinical guidelines and current evidence was used as a basis for consultation exercises at five physiotherapy departments. The findings from these were used to inform a national survey, administered to 43 NHS sites which had expressed an interest in taking part in the ARTISAN RCT, to establish (1) what protocols are in use across the UK and (2) current care pathways. Of the 43 responders, 7 used locally developed physiotherapy protocols. Sites were consistent with an educational component and phased exercise approach for rehabilitation.
Patient and public involvement
We presented the intervention to a patient group who framed the intervention around their experiences and expectations of physiotherapy after TASD. The patient and public involvement (PPI) group discussed that although the content was relevant, it lacked information to help them understand their injury more fully and aid with adherence to the programme, which the group all agreed was difficult at times.
Subsequently, the intervention was further refined to include behavioural components to facilitate self-management and aid with adherence. This included additional information to improve understanding of the injury and expected length of recovery, goal-setting and an exercise log. Following these refinements, the intervention was presented back to both our patient group and clinicians for final feedback prior to clinical implementation.
Research objectives
Our primary objective was to quantify and draw inferences about observed differences in Oxford Shoulder Instability Score (OSIS) between the trial treatment groups 6 months post randomisation, for adults with first-time TASD managed non-operatively. Our secondary objectives were:
- To estimate comparative cost-effectiveness [cost/quality-adjusted life-year (QALY)] of the two trial treatments, from an NHS and personal social services (PSS) perspective.
- To determine the complication rate (i.e. shoulder re-dislocation) in the first 12 months between the trial treatment groups.
- To quantify and draw inferences between the functional status (OSIS) of the trial treatment groups at 6 weeks and at 3 and 12 months.
- To quantify and draw inferences on observed differences in the functional status (QuickDASH) between the trial treatment groups at 6 weeks and at 3, 6 and 12 months.
- To quantify and draw inferences on observed differences of health-related quality of life [EuroQol-5 Dimensions, five-level version (EQ-5D-5L)] between the trial treatment groups at 6 weeks and at 3, 6 and 12 months.
- To qualitatively explore participants’ experience of receiving the trial treatments and facilitators and obstacles to adhering to them.