Authors' objectives: The extra benefit of a programme of physiotherapy in addition to advice alone, following first-time traumatic shoulder dislocation, is uncertain. We compared the clinical and cost-effectiveness of a single session of advice with a single session of advice and a programme of physiotherapy. The primary objective was to quantify and draw inferences about observed differences in the Oxford Shoulder Instability Score between the trial treatment groups 6 months post randomisation, in adults with a first-time traumatic shoulder dislocation. 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 [Brownson P, Donaldson O, Fox M, Rees JL, Rangan A, Jaggi A, et al. BESS/BOA Patient Care Pathways: Traumatic anterior shoulder instability. Shoulder Elbow 2015;7(3):214–26]. 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 [Brownson et al. 2015; Hanchard NC, Goodchild LM, Kottam L. Conservative management following closed reduction of traumatic anterior dislocation of the shoulder. Cochrane Database Syst Rev 2014;(4):CD004962; Berendes TD, Pilot P, Nagels J, Vochteloo AJ, Nelissen RG. Survey on the management of acute first-time anterior shoulder dislocation amongst Dutch public hospitals. Arch Orthop Trauma Surg 2015;135(4):447–54]. People with a traumatic anterior shoulder dislocation (TASD) may have ongoing pain, disability and substantial morbidity linked to high recurrence rates and subsequent need for repeated episodes of management (Brownson et al. 2015; Hanchard et al. 2014; Berendes et al. 2015). Re-dislocation following a first-time traumatic event typically occurs within 12 months of the index dislocation [Zacchilli MA, Owens BD. Epidemiology of shoulder dislocations presenting to emergency departments in the United States. J Bone Joint Surg Am 2010;92(3):542–9]. 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 (Hanchard et al. 2014). However, a 2014 Cochrane review did not find an evidence base to support this (Hanchard et al. 2014). Dutch national guidelines explicitly state no referral to physiotherapy should be made, and UK guidelines cite referral ‘may be helpful’ (Brownson et al. 2015; Berendes et al. 2015). Consequently, 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 (NHS Reference cost). In addition to the cost of providing a physiotherapy service, 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 of advice, 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 (Brownson et al. 2015). The primary objective was to test a single session of advice and physiotherapy versus a single session of advice only, for adults with first-time TASD managed non-operatively at 6 months using the Oxford Shoulder Instability Score (OSIS).

Authors' results and conclusions: Between 14 November 2018 and 14 March 2022, 482 participants were randomised to advice (n = 240) or advice and a programme of physiotherapy (n = 242). Participants were 34% female, with a mean age of 45 years, and treatment arms were balanced at baseline. There was not a statistically significant difference in the primary outcome between advice only and advice plus a programme of physiotherapy at 6 months for the primary intention-to-treat adjusted analysis (favours physiotherapy: 1.5, 95% confidence interval −0.3 to 3.5) or at earlier 3-month and 6-week time points on the Oxford Shoulder Instability Score (0–48; higher scores indicate better function). The probability of physiotherapy being cost-effective at a willingness-to-pay threshold of £30,000 was 0.95. We found little difference in the primary outcome or other secondary outcomes. Advice with additional physiotherapy sessions was found likely to be cost-effective. However, small imprecise incremental costs and quality-adjusted life-years raise questions on whether it is the best use of scarce physiotherapy resources given current service demands. Between 14 November 2018 and 14 March 2022 we recruited from 41 NHS Trusts, who screened 1551 adults with a traumatic shoulder dislocation, from whom 1069 were not randomised. Forty of the 41 NHS Trust teams randomised the remaining 482 to advice only (n = 240) or advice and a programme of physiotherapy (n = 242). Ten participants withdrew prior to the primary outcome point of 6 months; 354 participants completed the primary outcome OSIS (73%) and were included in the final analysis. Across the groups there were high levels of adherence. Ninety-six physiotherapists delivered the interventions across the 41 sites. Two participants in the advice-only group (n = 240) crossed over to receive a programme of physiotherapy because in the opinion of the treating clinician a programme of further physiotherapy was needed. A further 42 participants self-referred to receive a programme of physiotherapy. A total of 194 participants received advice only, and there were missing data on two participants. In the group randomised to advice and further physiotherapy, 24 participants did not attend any additional appointments, 30 participants did not attend after one appointment, 167 had a complete programme of physiotherapy and 18 were receiving ongoing management after the 4-month period. There were three participants with missing data. There was no evidence of a statistically significant difference in OSIS between advice only and advice plus a programme of physiotherapy in the 6-month primary outcome, for the primary intention-to-treat adjusted analysis [favours physiotherapy: 1.5, 95% confidence interval (CI) −0.30 to 3.5] or at earlier 3-month and 6-week time points. At each time point the direction of change favoured a programme of physiotherapy; however, the 95% CI at each time point excluded our target four-point difference on the OSIS. There were no statistically significant differences in the QuickDASH or consistent differences in the EQ-5D-5L secondary outcomes. Secondary unadjusted and per-protocol analyses, and a sensitivity analysis accounting for missingness, were not materially different. Predefined subgroup analyses were undertaken to assess whether there was evidence that the intervention effect differed between age group (≤ 39 years old and ≥ 40 years old) and arm dominance. Our predefined subgroup analyses showed no evidence of clinically relevant effects from either age or arm dominance. Predefined complications profiles were similar across the two groups. In the advice group, there were reports of 7 shoulder re-dislocations, 3 frozen shoulders, 8 compression fractures of the shoulder, 22 rotator cuff tears and 1 report of nerve damage. In the additional physiotherapy group, there were 3 shoulder re-dislocations, 7 frozen shoulders, 21 rotator cuff tears and 4 compression fractures of the shoulder. Participants randomised to a programme of physiotherapy had non-significant increase in quality of life of 0.019 quality-adjusted life-years (QALYs) (95% CI −0.0005 to 0.0375) at a small, non-significant increased cost of £64 (95% CI −61 to 191) over the follow-up period. The probability of being cost-effective at a willingness-to-pay threshold of £30,000 was 0.946. Sensitivity analyses, including complete cases only and including broader societal costs, provided similar findings. Thirty-one participants were interviewed from both arms of the trial: ARTISAN [n = 16, 8 male and 8 female, mean age 49 years (standard deviation 21 years)] and ARTISAN Plus [n = 15, 11 male and 4 female, mean age 59 years (standard deviation 17 years)]. Four interlinked themes emerged from the data: (1) feelings about their shoulder rehabilitation outcome; (2) judgement of ARTISAN rehabilitation materials; (3) assessment of shoulder rehabilitation services provision; and (4) experiences of involvement in ARTISAN. The data reveal that generally across both arms of the trial, participants’ experiences were good. There are a number of areas where there are differences related to age and participants’ requirements to return to sporting activities. In terms of recovery following their rehabilitation journey, there is a trend towards a more positive outcome reported by those in the ARTISAN Plus arm of the trial. We found little difference in the primary outcome (OSIS) or other secondary outcomes. Advice with additional physiotherapy sessions is cost-effective at a £30,000/QALY threshold. However, the small imprecise health gains raise questions on whether it is the best use of scarce physiotherapy resources given current service demands. The ARTISAN trial is the largest RCT for the common shoulder dislocation. The study recruited 482 participants, across 41 NHS Trusts and using 96 ARTISAN-trained physiotherapists, making the sample representative of NHS patients. Adherence to trial groups was high, with 99% in the advice group being offered advice only and 100% in the additional physiotherapy group being offered additional physiotherapy. The advice-only intervention was delivered by physiotherapists and crucially did not prohibit patients from self-referring back to the service if recovery did not meet their expectations. With this mechanism in place, 18% (42/240) self-referred back to the service. Empowering people to make their own treatment decisions was acceptable to clinicians (99% adherence) and allows flexibility for patients to decide when additional supervised treatment is required. It is acknowledged that there will be circumstances where additional supervised physiotherapy is appropriate; however, as a default referral pathway, it is not clinically superior to an advice-only intervention. The ARTISAN trial found evidence that there is little difference between referring people to a programme of physiotherapy or to a single session of advice with a physiotherapist. However, people who are not experiencing recovery as expected could self-refer for a supervised programme of physiotherapy. This will provide a balance between best use of NHS resources, empowering patients, and reducing unnecessary appointments for those who can self-manage. Further research should be directed towards optimising self-management strategies.

Authors' methods: A pragmatic, multicentre, superiority, randomised controlled trial with embedded qualitative study. Forty-one hospitals in the UK NHS. Adults with a radiologically confirmed first-time traumatic anterior shoulder dislocation, being managed non-operatively. People with neurovascular complications or bilateral dislocations, and those unable to adhere to trial procedures or unable to attend physiotherapy within 6 weeks of injury, or who had previously been randomised, were excluded. All participants received the same initial shoulder examination followed by advice to aid self-management, lasting up to 1 hour and administered by a physiotherapist (control). Participants randomised to receive an additional programme of physiotherapy were offered sessions lasting for up to 30 minutes, over a maximum duration of 4 months from the date of randomisation (intervention). The primary outcome measure was the Oxford Shoulder Instability Score. This is a self-completed outcome measure containing 12 questions (0–4 points each), with possible scores from 0 (worst function) to 48 (best function). Measurements were collected at 6 weeks, 3 months, 6 months and 12 months by postal questionnaire; 6 months was the primary outcome time point. The primary health outcome for economic evaluation was the quality-adjusted life-year, in accordance with National Institute of Health and Care Excellence guidelines. Loss to follow-up was 27%; however, the observed standard deviation was much smaller than anticipated. These changes in parameters reduced the number of participants required to observe the planned target difference of four points. Our post hoc sensitivity analysis, accounting for missing data, gives similar results. Design A UK multicentre, two-arm, parallel group, superiority, randomised controlled trial (RCT) with 1 : 1 treatment allocation, across 41 NHS sites, with embedded qualitative study. A protocol paper has been previously published [Kearney RS, Dhanjal G, Parsons N, Ellard D, Parsons H, Haque A, et al. Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN): protocol for a multicentre randomised controlled trial. BMJ Open 2020;10(11):e040623]. The final protocol, statistical analysis plan and health economic analysis plan are publicly available. People were eligible to be included in the trial if they were adults (≥ 18 years) with a first-time TASD confirmed radiologically. People were excluded if they had neurovascular complications or bilateral dislocations, were unable to adhere to trial procedures or unable to attend physiotherapy within 6 weeks of injury, or had been previously included in the trial. After potential participants were assessed, informed written consent was obtained by a site-based researcher trained in good clinical practice.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/16/167/56

Year Published: 2024

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/CMYW9226/

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/CMYW9226

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk