Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN): protocol for a multicentre randomised controlled trial

Kearney, Rebecca S.; Dhanjal, Gurmit; Parsons, Nicholas R.; Ellard, David R; Parsons, Helen; Haque, Aminul; Karasouli, Eleni; Mason, James; Nwankwo, Henry; Brown, Jaclyn; Liew, ZiHeng; Drew, Steve; Modi, Chetan S.; Bush, Howard S.; Torgerson, David; Underwood, Martin

doi:10.1136/bmjopen-2020-040623

“…These independent committees were convened to oversee the study throughout the trial duration. The ARTISAN protocol was accepted for publication on October 13 2020 and first published on November 19 2020 8. The statistical analysis plan is available in Supplement 1.…”

Section: Methodsmentioning

confidence: 99%

“…The ARTISAN protocol was accepted for publication on October 13 2020 and first published on November 19 2020. 8 The statistical analysis plan is available in Supplement 1. The ARTISAN study was prospectively registered on 7 September 2018 (ISRCTN63184243).…”

Section: Methodsmentioning

confidence: 99%

Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled trial

Kearney,

Ellard,

Parsons

et al. 2024

BMJ

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Objective To assess the effects of an additional programme of physiotherapy in adults with a first-time traumatic shoulder dislocation compared with single session of advice, supporting materials, and option to self-refer to physiotherapy. Design Pragmatic, multicentre, randomised controlled trial (ARTISAN). Setting and participants Trauma research teams at 41 UK NHS Trust sites screened adults with a first time traumatic anterior shoulder dislocation confirmed radiologically, being managed non-operatively. People were excluded if they presented with both shoulders dislocated, had a neurovascular complication, or were considered for surgical management. Interventions One session of advice, supporting materials, and option to self-refer to physiotherapy (n=240) was assessed against the same advice and supporting materials and an additional programme of physiotherapy (n=242). Analyses were on an intention-to-treat basis with secondary per protocol analyses. Main outcome measures The primary outcome was the Oxford shoulder instability score (a single composite measure of shoulder function), measured six months after treatment allocation. Secondary outcomes included the QuickDASH, EQ-5D-5L, and complications. Results 482 participants were recruited from 40 sites in the UK. 354 (73%) participants completed the primary outcome score (n=180 allocated to advice only, n=174 allocated to advice and physiotherapy). Participants were mostly male (66%), with a mean age of 45 years. No significant difference was noted between advice compared with advice and a programme of physiotherapy at six months for the primary intention-to-treat adjusted analysis (between group difference favouring physiotherapy 1.5 (95% confidence interval −0.3 to 3.5)) or at earlier three month and six week timepoints. Complication profiles were similar across the two groups (P>0.05). Conclusions An additional programme of current physiotherapy is not superior to advice, supporting materials, and the option to self-refer to physiotherapy. Trial registration Current Controlled Trialsisrctn63184243.

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Physiotherapy rehabilitation experiences of people with shoulder dislocation in ARTISAN study: a qualitative study

Naghdi,

Ellard,

Kearney

2024

BMJ Open

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BackgroundAcute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN) was a large trial comparing the clinical and cost-effectiveness of two rehabilitation interventions in adults with a first-time traumatic shoulder dislocation. Participants were allocated to receive either a single session of advice (ARTISAN) or a single session of advice and a programme of physiotherapy (ARTISAN plus). Trial results illustrated that additional physiotherapy after an initial session was not superior in improving functional outcomes for participants.ObjectivesIn this study, we aim to explore the experiences of a purposive sample of participants from both the ARTISAN and ARTISAN plus groups regarding their rehabilitation journey.DesignThis is a semistructured interview-based study.SettingThe study was conducted in the United Kingdom.ParticipantsThirty-one participants of ARTISAN trial: 16 participants from ARTISAN group and 15 from ARTISAN plus group.Outcome measures and analysisThe study follows the consolidated criteria for reporting qualitative research. The framework analysis was used to synthesise the participants’ experiences. The interviews were coded through NVivo 12.6.1.ResultsThree dominant and interrelated topics emerged from the interview data: (1) feelings about their shoulder rehabilitation outcome, (2) judgement of ARTISAN rehabilitation materials, (3) assessment of shoulder rehabilitation service provision.ConclusionBoth forms of intervention have some merit for some individuals. Thus, it may be appropriate to look at the patients’ preference for offering treatment to them. Recognising and facilitating this will be of benefit to both the patients and healthcare as a whole.

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Advice only versus advice and a physiotherapy programme for acute traumatic anterior shoulder dislocation: the ARTISAN RCT

Kearney,

Ellard,

Parsons

et al. 2024

Health Technol Assess

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Background 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. Objective 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. Design A pragmatic, multicentre, superiority, randomised controlled trial with embedded qualitative study. Setting Forty-one hospitals in the UK NHS. Participants 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. Interventions 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). Main outcome measures 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. Results 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. Conclusions 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. Limitations 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. Future work Further research should be directed towards optimising self-management strategies. Study registration This study is registered as ISRCTN63184243. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/167/56) and is published in full in Health Technology Assessment; Vol. 28, No. 22. See the NIHR Funding and Awards website for further award information.

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Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN): protocol for a multicentre randomised controlled trial

Cited by 5 publications

References 17 publications

Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled trial

Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled trial

Physiotherapy rehabilitation experiences of people with shoulder dislocation in ARTISAN study: a qualitative study

Advice only versus advice and a physiotherapy programme for acute traumatic anterior shoulder dislocation: the ARTISAN RCT

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