Dataset Information

Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department - a multicentre, randomised, controlled study protocol.

ABSTRACT:

Introduction

Anterior shoulder dislocation is a common reason for consultation at the emergency department (ED). Hypnosis could be a safe and effective alternative therapy for pain relief during shoulder dislocation reduction but nowadays, evidence is not sufficient. The main objective of this study is to show that reduction under hypnosis is associated with a decrease in the use of analgesic compared with usual care.

Methods and analysis

We will conduct an interventional, controlled, multicentre, randomised study. A total of 44 patients with shoulder dislocation will be randomised in two groups: the hypnosis group (N=22) and the usual care group (N=22). The primary endpoint will be the comparison of morphine equivalent analgesic consumption during a shoulder dislocation reduction manoeuvre. Secondary endpoints will include haemodynamic parameters monitoring, patient and practitioner satisfaction using a Likert scale, use of coanalgesic or sedative drugs, number of reduction attempts and time spent at ED. Adverse events will be recorded. Statistical analysis will include parametric tests, multivariate linear regression and descriptive statistics.

Ethics and dissemination

This study has received ethics approval from the Comité de Protection des Personnes of Sud-Est IV on 03/11/2021 (ANSM informed on 19 November 2021). The results will be published in scientific articles and communicated in national and international conferences.

Trial registration number

ClinicalTrial.gov: NCT04992598; National Clinical trial no ID RCB : 2021-A01382-39.

SUBMITTER: Tinelli M

PROVIDER: S-EPMC9730355 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department - a multicentre, randomised, controlled study protocol.

Tinelli Marion M Guler Nazmine N Goetz Christophe C Aim Philippe P Marchionni Sandra S Ouamara Nadia N Cipolat Lauriane L Demarquet Marine M Seris Emmanuelle E Moreau Alexia A Durand Guillaume G Douplat Marion M Lavignon Jean-Pierre JP Hingray Coraline C Abensur Vuillaume Laure L

BMJ open 20221207 12

<h4>Introduction</h4>Anterior shoulder dislocation is a common reason for consultation at the emergency department (ED). Hypnosis could be a safe and effective alternative therapy for pain relief during shoulder dislocation reduction but nowadays, evidence is not sufficient. The main objective of this study is to show that reduction under hypnosis is associated with a decrease in the use of analgesic compared with usual care.<h4>Methods and analysis</h4>We will conduct an interventional, control ...[more]

PMID: 36600368

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Project description:ObjectiveAnterior shoulder dislocations are commonly treated in the emergency department (ED). Analgesia for reduction is provided by intra-articular lidocaine (IAL) injection or intravenous sedation (IV sedation). The objective of this systematic review and meta-analysis was to compare IAL versus IV sedation for closed reduction of acute anterior shoulder dislocation in the ED.MethodsElectronic searches of MEDLINE and EMBASE (1946-September 2021) were completed and reference lists were hand-searched. Randomized controlled trials (RCTs) comparing IAL and IV sedation for reduction of acute anterior shoulder dislocations among patients ≥ 15 years old in the ED were included. Outcomes of interest included a successful reduction, adverse events, ED length of stay, pain scores, procedure time, ease of reduction, patient satisfaction, and cost. Two reviewers independently screened abstracts, assessed study quality and extracted data. Data were pooled using random-effects models and reported as mean differences and risk ratios (RR) with 95% confidence intervals (CIs).Results12 RCTs were included with a total of 630 patients (IAL = 327; IV sedation = 303). There was no difference in reduction success between IAL and IV sedation (RR 0.93; 95% CI 0.86-1.01, I2 = 69%), significantly lower adverse events with IAL (RR 0.16; 95% CI 0.07-0.33, I2 = 0%), shorter ED length of stay with IAL (mean difference - 1.48; 95% CI - 2.48 to - 0.47, I2 = 93%), no difference in pain scores post-analgesia and no difference in ease of reduction.ConclusionsIntra-articular lidocaine may have similar effectiveness as IV sedation in the successful reduction of anterior shoulder dislocations in the ED with fewer adverse events, shorter ED length of stay, and no difference in pain scores or ease of reduction. Intra-articular lidocaine may be an effective alternative to IV sedation for reducing anterior shoulder dislocations, particularly when IV sedation is contraindicated or not feasible.

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:ObjectiveTo 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.DesignPragmatic, multicentre, randomised controlled trial (ARTISAN).Setting and participantsTrauma 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.InterventionsOne 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 measuresThe 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.Results482 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).ConclusionsAn additional programme of current physiotherapy is not superior to advice, supporting materials, and the option to self-refer to physiotherapy.Trial registrationCurrent Controlled Trials ISRCTN63184243.

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Dataset Information

Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department - a multicentre, randomised, controlled study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department - a multicentre, randomised, controlled study protocol.

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