Dataset Information

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

ABSTRACT:

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 Trials ISRCTN63184243.

SUBMITTER: Kearney RS

PROVIDER: S-EPMC10792684 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

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Publications

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

Kearney Rebecca S RS Ellard David R DR Parsons Helen H Haque Aminul A Mason James J Nwankwo Henry H Bradley Helen H Drew Stephen S Modi Chetan C Bush Howard H Torgerson David D Underwood Martin M

BMJ (Clinical research ed.) 20240117

<h4>Objective</h4>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.<h4>Design</h4>Pragmatic, multicentre, randomised controlled trial (ARTISAN).<h4>Setting and participants</h4>Trauma research teams at 41 UK NHS Trust sites screened adults with a first time traumatic anterior shoulder dislocation confirmed radiological ...[more]

PMID: 38233068

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Project description:IntroductionGlenohumeral (shoulder) dislocations are the most common large joint dislocations seen in the emergency department (ED). They cause pain, often severe, and require timely interventions to minimise discomfort and tissue damage. Commonly used reposition or relocation techniques often involve traction and/or leverage. These techniques have high success rates but may be painful and time consuming. They may also cause complications. Recently, other techniques-the biomechanical reposition techniques (BRTs)-have become more popular since they may cause less pain, require less time and cause fewer complications. To our knowledge, no research exists comparing the various BRTs. Our objective is to establish which BRT or BRT combination is fastest, least painful and associated with the lowest complication rate for adult ED patients with anterior glenohumeral dislocations (AGDs).Methods and analysisAdults presenting to the participating EDs with isolated AGDs, as determined by radiographs, will be randomised to one of three BRTs: Cunningham, modified Milch or scapular manipulation. Main study parameters/endpoints are ED length of stay and patients' self-report of pain. Secondary study parameters/endpoints are procedure times, need for analgesic and/or sedative medications, iatrogenic complications and rates of successful reduction.Ethics and disseminationNon-biomechanical AGD repositioning techniques based on traction and/or leverage are inherently painful and potentially harmful. We believe that the three BRTs used in this study are more physiological, more patient friendly, less likely to cause pain, more time efficient and less likely to produce complications. By comparing these three techniques, we hope to improve the care provided to adults with acute AGDs by reducing their ED length of stay and minimising pain and procedure-related complications. We also hope to define which of the three BRTs is quickest, most likely to be successful and least likely to require sedative or analgesic medications to achieve reduction.Trial registration numberNTR5839.

Project description:BackgroundThere is an important gap in knowledge about the effectiveness of nonoperative treatment (exercise) for patients with traumatic primary and recurrent anterior shoulder dislocations (ASDs).Purpose/hypothesisThe purpose of this study was to assess the efficacy and safety of physical therapist-supervised, shoulder instability neuromuscular exercise (SINEX) versus self-managed, home-based, standard care shoulder exercise (HOMEX) in patients with traumatic ASDs. The hypothesis was that SINEX would have a larger effect and fewer adverse events compared with HOMEX.Study designRandomized controlled trial; Level of evidence, 2.MethodsA total of 56 participants with radiographically verified, trauma-initiated primary or recurrent ASDs and self-reported decreased shoulder function were randomized to 12 weeks of either SINEX or HOMEX. The SINEX program consisted of 7 exercises, individually progressing from basic (2 × 20 repetitions each day) to elite (2 × 10 repetitions, 3 times weekly). The HOMEX program included 5 shoulder exercises performed 3 times weekly (2 × 10 repetitions). The primary outcome was the Western Ontario Shoulder Instability Index (WOSI) score, ranging from 0 (best possible) to 2100. The between-group minimal clinically important difference at 12 weeks was 250 points. Secondary outcomes included WOSI subdomain scores, patient-reported ratings of kinesiophobia and pain, objective shoulder function, patient satisfaction, and number of adverse events.ResultsThe between-group mean difference in the WOSI total score at 12 weeks significantly favored SINEX over HOMEX (-228.1 [95% CI, -430.5 to -25.6]). SINEX was furthermore superior to HOMEX in most of the secondary outcomes (3/4 subdomains of the WOSI and pain level during the past 7 days as well as clinical signs of anterior shoulder instability). Also, although not statistically significant, less than half the proportion of the SINEX patients compared with the HOMEX patients (3/27 [11%] vs 6/24 [25%], respectively; P = .204) underwent or were referred for shoulder stabilizing surgery. Satisfaction with both exercise programs was high, and no serious adverse events were reported.ConclusionNeuromuscular shoulder exercise (SINEX) was superior to standard care exercise (HOMEX) in patients with traumatic ASDs. Further long-term follow-ups on treatment effects are needed.RegistrationNCT02371928 (ClinicalTrials.gov identifier).

Dataset Information

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

Objective

Design

Setting and participants

Interventions

Main outcome measures

Results

Conclusions

Trial registration

Publications

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

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