Tailored exercise and manual therapy versus standardised exercise for patients with shoulder subacromial pain: a feasibility randomised controlled trial (the Otago MASTER trial)

Objectives
The aim of this study was to assess whether it was feasible to conduct a full trial comparing a tailored versus a standardised exercise programme for patients with shoulder subacromial pain.

Design
Two-arm, patient-blinded and assessor-blinded, randomised controlled feasibility trial.

Methods
Twenty-eight participants with shoulder subacromial pain were randomly allocated into one of two intervention groups—tailored or standardised exercise. Participants in the tailored exercise programme received exercises and manual therapy tailored to their scapular and shoulder movement impairments. Participants in the standardised exercise programme received progressive strengthening exercise. The primary outcome measures were (1) the participant recruitment rate; (2) the proportion of participants enrolled from the total number screened; (3) drop-out rates; and (4) adherence to the rehabilitation programme. Other outcome measures were: (5) pain levels; (6) Patient-Specific Functional Scale; (7) the Shoulder Pain and Disability Index; and (8) pain self-efficacy. We compared changes in pain and disability scores between groups using a repeated mixed-model analysis of variance. Since this is a feasibility study, we did not adjust alpha for multiple comparisons, and considered 75% CI as the probability threshold at 3-month follow-up. Health-related quality of life was assessed using the Short-Form 12 and quality-adjusted life years (QALYs) were estimated.

Results
The recruitment rate was 3 participants per month, the proportion of participants enrolled was 23%, the drop-out rate was 14% and the overall adherence to the rehabilitation programme was 85%. No between-group differences were found for most outcome measures. Adverse events (n=2, only in the tailored group) were minor in nature and included skin injury or pain following taping.

Conclusions
Our feasibility trial showed that additional strategies are required for improving recruitment, enrolment and minimising drop-out of participants into the trial and making it feasible to conduct a full trial.

Trial registration number
ANZCTR: 12617001405303.

Leggi
Giugno 2022

Effectiveness of interventions for middle-aged and ageing population with neck pain: a systematic review and network meta-analysis protocol

Introduction
Neck pain (NP) is a common musculoskeletal complaint and is increasing in prevalence. Current clinical practice guidelines and systematic reviews recommended conservative, pharmacological and invasive interventions for individuals with NP. However, optimal management specifically for those who are middle-aged or older adults (≥45 years) is not available; and important considering our ageing population.

Methods and analysis
A systematic review with network meta-analysis (NMA) will be conducted following the Cochrane guidelines. Eligibility criteria include randomised controlled/clinical trials evaluating any of acute (

Leggi
Giugno 2022

High-definition transcranial infraslow pink noise stimulation for chronic low back pain: protocol for a pilot, safety and feasibility randomised placebo-controlled trial

Introduction
Chronic low back pain (CLBP) is a common disabling health condition. Current treatments demonstrate modest effects, warranting newer therapies. Brain imaging demonstrates altered electrical activities in cortical areas responsible for pain modulation, emotional and sensory components of pain experience. Treatments targeting to change electrical activities of these key brain regions may produce clinical benefits. This pilot study aims to (1) evaluate feasibility, safety and acceptability of a novel neuromodulation technique, high-definition transcranial infraslow pink noise stimulation (HD-tIPNS), in people with CLBP, (2) explore the trend of effect of HD-tIPNS on pain and function, and (3) derive treatment estimates to support sample size calculation for a fully powered trial should trends of effectiveness be present.

Methods and analysis
A pilot, triple-blinded randomised two-arm placebo-controlled parallel trial. Participants (n=40) with CLBP will be randomised to either sham stimulation or HD-tIPNS (targeting somatosensory cortex and dorsal and pregenual anterior cingulate cortex). Primary outcomes include feasibility and safety measures, and clinical outcomes of pain (Brief Pain Inventory) and disability (Roland-Morris disability questionnaire). Secondary measures include clinical, psychological, quantitative sensory testing and electroencephalography collected at baseline, immediately postintervention, and at 1-week, 1-month and 3 months postintervention. All data will be analysed descriptively. A nested qualitative study will assess participants perceptions about acceptability of intervention and analysed thematically.

Ethics and dissemination
Ethical approval has been obtained from Health and Disability Ethics Committee (Ref:20/NTB/67). Findings will be reported to regulatory and funding bodies, presented at conferences, and published in a scientific journal.

Trial registration number
ACTRN12620000505909p.

Leggi
Giugno 2022

On the road to universal coverage of postnatal care: considerations for a targeted postnatal care approach for at-risk mother-baby dyads in low-income and middle-income countries informed by a consultation with global experts

Introduction
The potential of timely, quality postnatal care (PNC) to reduce maternal and newborn mortality and to advance progress toward universal health coverage (UHC) is well-documented. Yet, in many low-income and middle-income countries, coverage of PNC remains low. Risk-stratified approaches can maximise limited resources by targeting mother–baby dyads meeting the evidence-based risk criteria which predict poor postnatal outcomes.

Objectives
To review evidence-based risk criteria for identification of at-risk mother–baby dyads, drawn from a literature review, and to identify key considerations for their use in a risk-stratified PNC approach.

Design/setting/participants
A virtual, semi-structured group discussion was conducted with maternal and newborn health experts on Zoom. Participants were identified through purposive sampling based on content and context expertise.

Results
Seventeen experts, (5 men and 12 women), drawn from policymakers, implementing agencies and academia participated and surfaced several key themes. The identified risk factors are well-known, necessitating accelerated efforts to address underlying drivers of risk. Risk-stratified PNC approaches complement broader UHC efforts by providing an equity lens to identify the most vulnerable mother–baby dyads. However, these should be layered on efforts to strengthen PNC service provision for all mothers and newborns. Risk factors should comprise context-relevant, operationalisable, clinical and non-clinical factors. Even with rising coverage of facility delivery, targeted postnatal home visits still complement facility-based PNC.

Conclusion
Risk-stratified PNC efforts must be considered within broader health systems strengthening efforts. Implementation research at the country level is needed to understand feasibility and practicality of clinical and non-clinical risk factors and identify unintended consequences.

Leggi
Giugno 2022

Positive end-expiratory pressure and risk of postoperative pulmonary complications in patients living at high altitudes and undergoing surgery at low altitudes: a single-centre, retrospective observational study in China

Objectives
To examine whether a high positive end-expiratory pressure (PEEP ≥5 cmH2O) has a protective effect on the risk of postoperative pulmonary complications (PPCs) in a cohort of patients living at high altitudes and undergoing general anaesthesia.

Design
Retrospective, observational study.

Setting
A tertiary hospital in China.

Participants
Adult Tibetan patients living at high altitudes (≥3000 m) and who went to the low-altitude plain to undergo non-cardiothoracic surgery under general anaesthesia, from January 2018 to April 2020.

Measurements
This study included 1905 patients who were divided according to the application of an intraoperative PEEP: low PEEP (5 cmH2O PEEP during intraoperative mechanical ventilation was associated with a significantly lower risk of PPCs in patients from a high altitude (OR=0.725, 95% CI 0.530 to 0.992; p=0.044).

Conclusions
The application of PEEP ≥5 cmH2O during intraoperative mechanical ventilation in patients living at high altitudes and undergoing surgery at low altitudes may be associated with a lower risk of PPCs. Prospective longitudinal studies are needed to further investigate perioperative lung protection ventilation strategies for patients from high altitudes.

Trial registration number
Chinese Clinical Trial Registry (ChiCTR2100044260).

Leggi
Giugno 2022

Association between chiropractic spinal manipulative therapy and benzodiazepine prescription in patients with radicular low back pain: a retrospective cohort study using real-world data from the USA

Objectives
Although chiropractic spinal manipulative therapy (CSMT) and prescription benzodiazepines are common treatments for radicular low back pain (rLBP), no research has examined the relationship between these interventions. We hypothesise that utilisation of CSMT for newly diagnosed rLBP is associated with reduced odds of benzodiazepine prescription through 12 months’ follow-up.

Design
Retrospective cohort study.

Setting
National, multicentre 73-million-patient electronic health records-based network (TriNetX) in the USA, queried on 30 July 2021, yielding data from 2003 to the date of query.

Participants
Adults aged 18–49 with an index diagnosis of rLBP were included. Serious aetiologies of low back pain, structural deformities, alternative neurological lesions and absolute benzodiazepine contraindications were excluded. Patients were assigned to cohorts according to CSMT receipt or absence. Propensity score matching was used to control for covariates that could influence the likelihood of benzodiazepine utilisation.

Outcome measures
The number, percentage and OR of patients receiving a benzodiazepine prescription over 3, 6 and 12 months’ follow-up prematching and postmatching.

Results
After matching, there were 9206 patients (mean (SD) age, 37.6 (8.3) years, 54% male) per cohort. Odds of receiving a benzodiazepine prescription were significantly lower in the CSMT cohort over all follow-up windows prematching and postmatching (p

Leggi
Giugno 2022

Randomised, pragmatic, waitlist controlled trial of cannabis added to prescription opioid support on opioid dose reduction and pain in adults with chronic non-cancer pain: study protocol

Introduction
Chronic, non-cancer pain impacts approximately 50 million adults in the USA (20%), approximately 25% of whom receive chronic prescription opioids for pain despite limited empirical efficacy data and strong dose-related risk for opioid use disorder and opioid overdose. Also despite lack of efficacy data, there are many reports of people using cannabis products to manage chronic pain and replace or reduce chronic opioids. Here we describe the protocol for a randomised trial of the effect of cannabis, when added to a behavioural pain management and prescription opioid taper support programme, on opioid utilisation, pain intensity and pain interference.

Methods
This is a pragmatic, single-blind, randomised, wait-list controlled trial that aims to enrol 250 adults taking prescription opioids at stable doses of ≥25 morphine milligram equivalents per day for chronic non-cancer pain who express interest in using cannabis to reduce their pain, their opioid dose or both. All participants will be offered a weekly, 24-session Prescription Opioid Taper Support group behavioural pain management intervention. Participants will be randomly assigned in 1:1 ratio to use cannabis products, primarily from commercial cannabis dispensaries or to abstain from cannabis use for 6 months. Coprimary outcomes are change in prescription monitoring programme-verified opioid dose and change in Pain, Enjoyment, General Activity scale scores. Secondary outcomes include quality of life, depression, anxiety, self-reported opioid dose and opioid and cannabis use disorder symptoms. All other outcomes will be exploratory. We will record adverse events.

Ethics and dissemination
This study has ethical approval by the Massachusetts General Brigham Institutional Review Board (#2021P000871). Results will be published in peer-reviewed journals and presented at national conferences.

Trial registration number
NCT04827992.

Leggi
Giugno 2022

Perceived usefulness of trauma audit filters in urban India: a mixed-methods multicentre Delphi study comparing filters from the WHO and low and middle-income countries

Objective
To compare experts’ perceived usefulness of audit filters from Ghana, Cameroon, WHO and those locally developed; generate context-appropriate audit filters for trauma care in selected hospitals in urban India; and explore characteristics of audit filters that correlate to perceived usefulness.

Design
A mixed-methods approach using a multicentre online Delphi technique.

Setting
Two large tertiary hospitals in urban India.

Methods
Filters were rated on a scale from 1 to 10 in terms of perceived usefulness, with the option to add new filters and comments. The filters were categorised into three groups depending on their origin: low and middle-income countries (LMIC), WHO and New (locally developed), and their scores compared. Significance was determined using Kruskal-Wallis test followed by Wilcoxon rank-sum test. We performed a content analysis of the comments.

Results
26 predefined and 15 new filter suggestions were evaluated. The filters had high usefulness scores (mean overall score 9.01 of 10), with the LMIC filters having significantly higher scores compared with those from WHO and those newly added. Three themes were identified in the content analysis relating to medical relevance, feasibility and specificity.

Conclusions
Audit filters from other LMICs were deemed highly useful in the urban India context. This may indicate that the transferability of defined trauma audit filters between similar contexts is high and that these can provide a starting point when implemented as part of trauma quality improvement programmes in low-resource settings.

Leggi
Giugno 2022

Signature for Pain Recovery IN Teens (SPRINT): protocol for a multisite prospective signature study in chronic musculoskeletal pain

Introduction
Current treatments for chronic musculoskeletal (MSK) pain are suboptimal. Discovery of robust prognostic markers separating patients who recover from patients with persistent pain and disability is critical for developing patient-specific treatment strategies and conceiving novel approaches that benefit all patients. Given that chronic pain is a biopsychosocial process, this study aims to discover and validate a robust prognostic signature that measures across multiple dimensions in the same adolescent patient cohort with a computational analysis pipeline. This will facilitate risk stratification in adolescent patients with chronic MSK pain and more resourceful allocation of patients to costly and potentially burdensome multidisciplinary pain treatment approaches.

Methods and analysis
Here we describe a multi-institutional effort to collect, curate and analyse a high dimensional data set including epidemiological, psychometric, quantitative sensory, brain imaging and biological information collected over the course of 12 months. The aim of this effort is to derive a multivariate model with strong prognostic power regarding the clinical course of adolescent MSK pain and function.

Ethics and dissemination
The study complies with the National Institutes of Health policy on the use of a single internal review board (sIRB) for multisite research, with Cincinnati Children’s Hospital Medical Center Review Board as the reviewing IRB. Stanford’s IRB is a relying IRB within the sIRB. As foreign institutions, the University of Toronto and The Hospital for Sick Children (SickKids) are overseen by their respective ethics boards. All participants provide signed informed consent. We are committed to open-access publication, so that patients, clinicians and scientists have access to the study data and the signature(s) derived. After findings are published, we will upload a limited data set for sharing with other investigators on applicable repositories.

Trial registration number
NCT04285112.

Leggi
Giugno 2022

Low back pain and associated factors among obstetrics care providers in public hospitals of Amhara Regional State, Ethiopia: a cross-sectional study

Objectives
Although the study of low back pain (LBP) among healthcare workers in Ethiopia is becoming common, it mainly focused on nurses leaving obstetrics care providers aside. The objective of this study was to assess the prevalence and associated factors of LBP among obstetrics care providers in public hospitals in Amhara Regional State, Ethiopia.

Design
An institution-based cross-sectional study.

Settings
The study settings were nine public hospitals in Amhara Region.

Participants
Randomly selected 416 obstetrics care providers working in public hospitals in Amhara Region, Ethiopia.

Outcomes
The outcomes of this study were the prevalence of LBP in the last 12 months among obstetrics care providers and its associated factors.

Results
Overall, the prevalence of LBP was 65.6% (95% CI 61.5% to 70.2%) among obstetrics care providers in the last 12 months.
Female gender (AOR 2.33, 95% CI 1.344 to 4.038), not having regular physical exercise habits (AOR 8.26, 95% CI 4.36 to 15.66), job stress (AOR 2.21, 95% CI 1.24 to 3.92), standing longer while doing procedures (AOR 2.04, 95% CI 1.14 to 3.66) and working more than 40 hours a week (AOR 2.20, 95% CI 1.09 to 4.45) were significantly associated with LBP.

Conclusion
About two-thirds of obstetrics care providers working in public hospitals in the Amhara region reported LBP. The prevalence of LBP was higher among those who did not have regular physical exercise habits, had job stress, stood longer than 1 hour while doing procedures, worked more than 40 hours a week and female obstetrics care providers. Providing resting periods, decreasing the working hours of obstetrics care providers in a week, and counselling on the importance of doing regular physical exercise help to reduce the prevalence of LBP.

Leggi
Giugno 2022

Lidocaine Infusion for the Management of Postoperative Pain and Delirium (LIMPP): protocol for a randomised control trial

Introduction
Postoperative delirium is a frequent adverse event following elective non-cardiac surgery. The occurrence of delirium increases the risk of functional impairment, placement to facilities other than home after discharge, cognitive impairment at discharge, as well as in-hospital and possibly long-term mortality. Unfortunately, there is a dearth of effective strategies to minimise the risk from modifiable risk factors, including postoperative pain control and the analgesic regimen. Use of potent opioids, currently the backbone of postoperative pain control, alters cognition and has been associated with an increased risk of postoperative delirium. Literature supports the intraoperative use of lidocaine infusions to decrease postoperative opioid requirements, however, whether the use of postoperative lidocaine infusions is associated with lower opioid requirements and subsequently a reduction in postoperative delirium has not been investigated.

Methods and analysis
The Lidocaine Infusion for the Management of Postoperative Pain and Delirium trial is a randomised, double-blinded study of a postoperative 48-hour infusion of lidocaine at 1.33 mg/kg/hour versus placebo in older patients undergoing major reconstructive spinal surgery at the University of California, San Francisco. Our primary outcome is incident delirium measured daily by the Confusion Assessment Method in the first three postoperative days. Secondary outcomes include delirium severity, changes in cognition, pain scores, opioid use, incidence of opioid related side effects and functional benefits including time to discharge and improved recovery from surgery. Lidocaine safety will be assessed with daily screening questionnaires and lidocaine plasma levels.

Ethics and dissemination
This study protocol has been approved by the ethics board at the University of California, San Francisco. The results of this study will be published in a peer-review journal and presented at national conferences as poster or oral presentations. Participants wishing to know the results of this study will be contacted directly on data publication.

Trial registration number
NCT05010148.

Leggi
Giugno 2022

Non-pharmacological interventions for the prevention of type 2 diabetes in low-income and middle-income countries: a systematic review of randomised controlled trials

Objective
Diabetes poses serious health threats and economic burdens to patients, especially in low-income and middle-income countries (LMICs). This systematic review searches for non-pharmacological interventions for the prevention of type-2 diabetes mellitus (T2DM) among patients who are non-diabetic and pre-diabetic from LMICs.

Settings
LMICs.

Participants
Adult population aged over 18 years without having diabetes.

Primary and secondary outcomes
Primary outcome is to measure the change in the incidence of T2DM. The secondary outcome is to measure changes in glycated haemoglobin (HbA1c) level, weight/body mass index (BMI), fasting glucose level and 2-hour glucose from baseline of the included randomised controlled trials.

Methods
This review has been conducted following the standard systematic review guidelines. A total of six electronic databases including MEDLINE, Embase, the Cochrane Library, Web of Science, ClinicalTrials.gov and International Clinical Trials Registry Platform were searched in February 2021 using a comprehensive search strategy.
Two sets of independent reviewers performed screening, risk of bias (ROB) assessment using the Cochrane ROB tool and data extraction. Narrative coalescence of selected articles was demonstrated using tables. No meta-analysis was performed due to the lack of homogenous intervention strategies and study settings.

Result
A total of five studies were included for the review with a combined population of 1734 from three countries. Three of the studies showed a significant reduction in T2DM incidence after the intervention of physical training and dietary modifications. Four of the studies also demonstrated a significant reduction of different secondary outcomes like weight, BMI, fasting and 2-hour plasma glucose and HbA1c. All the studies demonstrated a low ROB in most of the bias assessment domains with some unclear results in allocation concealments.

Conclusions
Emphasising non-pharmacological interventions for T2DM prevention can improve health outcomes and lessen the economic burdens, which will be of paramount importance in LMICs.

Systematic review registration number
CRD42020191507

Leggi
Giugno 2022

Dosage of joint mobilisation for the management of rotator cuff-related shoulder pain: protocol for a scoping review

Introduction
Rotator cuff-related shoulder pain is the most common diagnosis of shoulder pain, which ranks as the third most common musculoskeletal disorder. The first-line treatment for patients with rotator cuff-related shoulder pain is physiotherapy, and joint mobilisation is widely used in conjunction with other modalities. The type and dosage of joint mobilisations could influence treatment outcomes for patients with rotator cuff-related shoulder pain, although research evidence is inconclusive.

Objectives
To (1) systematically search, identify and map the reported type and dosage of joint mobilisations used in previous studies for the management of patients with rotator cuff-related shoulder pain; and (2) summarise the rationale for adopting a specific joint mobilisation dosage.

Methods and analysis
We will follow the methodological framework outlined by Arksey and O’Malley and report the results as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guideline. Two authors will independently screen and extract data from the six databases: PubMed, Scopus, Web of Science, CINAHL, Cochrane Library and SPORTDiscus, with publication date from their inceptions to 25 August 2021. A third author will be consulted if the two authors disagree about the inclusion of any study in the review. We will summarise the results using descriptive statistics and qualitative thematic analysis.

Ethics and dissemination
Ethical approval is not required for this protocol. Mapping and summarising the reported type and dosage of joint mobilisations for patients with rotator cuff-related shoulder pain from previous studies will provide a foundation for further optimal selection of type and dosage of joint mobilisations for treating patients with rotator cuff-related shoulder pain. The review is part of an ongoing research that focuses on joint mobilisation for patients with rotator cuff-related shoulder pain. The results will be disseminated through presentations at academic conferences and a peer-reviewed publication.

Leggi
Giugno 2022

Evaluation of two electronic-rehabilitation programmes for persistent knee pain: protocol for a randomised feasibility trial

Introduction
Persistent, knee pain is a common cause of disability. Education and exercise treatment are advocated in all clinical guidelines; however, the increasing prevalence of persistent knee pain presents challenges for health services regarding appropriate and scalable delivery of these treatments. Digital technologies may help address this, and this trial will evaluate the feasibility and acceptability of two electronic-rehabilitation interventions: ‘My Knee UK’ and ‘Group E-Rehab’.

Methods and analysis
This protocol describes a non-blinded, randomised feasibility trial with three parallel groups. The trial aims to recruit 90 participants (45 years or older) with a history of persistent knee pain consistent with a clinical diagnosis of knee osteoarthritis. Participants will be randomly assigned in a 1:1:1 allocation ratio. The ‘My Knee UK’ intervention arm will receive a self-directed unsupervised internet-based home exercise programme plus short message service support (targeting exercise behaviour change) for 12 weeks; the ‘Group E-Rehab’ intervention arm will receive group-based physiotherapist-prescribed home exercises delivered via videoconferencing accompanied by internet-interactive educational sessions for 12 weeks; the control arm will receive usual physiotherapy care or continue with their usual self-management (depending on their recruitment path). Feasibility variables, patient-reported outcomes and clinical findings measured at baseline, 3 and 9 months will be assessed and integrated with qualitative interview data from a subset of Group E-Rehab and My Knee UK participants. If considered feasible and acceptable, a definitive randomised controlled trial can be conducted to investigate the clinical effectiveness and cost-effectiveness of one or both interventions with a view to implementation in routine care.

Ethics and dissemination
The trial was approved by the West of Scotland Research Ethics Committee 5 (Reference: 20/WS/0006). The results of the study will be disseminated to study participants, the study grant funder and will be submitted for publication in peer-reviewed journals.

Trial registration number
ISRCTN15564385.

Leggi
Giugno 2022

Study protocol: an observational study of distress, immune function and persistent pain in HIV

Introduction
Many people with HIV report both distress and pain. The relationship between distress and pain is bidirectional, but the mechanisms by which distress exacerbates pain are unclear. The inflammatory response to challenge (inflammatory reactivity, IR) may be a partial mediator, given that neuroimmune interactions provide a substrate for IR to also influence neurological reactivity and, thus, pain-related neural signalling. This prospective, observational, case–control study will characterise the relationships between distress, IR, pain-related signalling as captured by induced secondary hyperalgesia (SH), and pain, in people with HIV who report persistent pain (PP) (cases) or no pain (controls).

Methods and analysis
One hundred people with suppressed HIV, reporting either PP or no pain, will be assessed two or four times over 6 months. The primary outcomes are distress (Hopkins 25-item symptom checklist), IR (multiplex assay after LPS challenge), and PP (Brief Pain Inventory), assessed at the baseline timepoint, although each will also be assessed at follow-up time points. Induced SH will be assessed in a subsample of 60 participants (baseline timepoint only). To test the hypothesis that IR partly mediates the relationship between distress and pain, mediation analysis will use the baseline data from the PP group to estimate direct and indirect contributions of distress and IR to pain. To test the hypothesis that IR is positively associated with SH, data from the subsample will be analysed with generalised mixed effects models to estimate the association between IR and group membership, with SH as the dependent variable.

Ethics and dissemination
Information obtained from this study will be published in peer-reviewed journals and presented at scientific meetings. The study has been approved by the Human Research Ethics Committee of the University of Cape Town (approval number: 764/2019) and the City of Cape Town (ref: 24699).

Trial registration number
NCT04757987.

Leggi
Giugno 2022