Risultati per: Low Back Pain: raccomandazioni

Introduction
Motor-evoked potentials (MEP) are widely used to mitigate the risk of nerve injury resulting from surgical manipulation. Infants are more susceptible to anaesthetics that suppress MEP because of the immaturity of their nervous structures. Current evidence of the impact of the interaction between a small dose of sevoflurane and propofol-based total intravenous anaesthesia (TIVA) on MEP in infants is controversial. This current study aims to evaluate the impact of the coadministration of low-dose sevoflurane with propofol-based TIVA on MEP in infants.

Methods and analysis
A randomised controlled study will be conducted at a single tertiary care children’s hospital in Japan between July 2024 and June 2029. Children between 35 and 87 weeks of postconceptual age undergoing spinal surgery requiring MEP under general anaesthesia will be enrolled in this study. The participants will be randomly allocated into two groups: propofol+remifentanil with (intervention group) or without (control group) low-dose sevoflurane (0.10–0.15 age-adjusted minimum alveolar concentration). MEP top-to-bottom amplitudes will be measured at two chronological points: T1 (first transcranial MEP (TcMEP) recording), T2 (second TcMEP recording) in the same patient. The primary and secondary endpoints will be a reduction in MEP amplitudes (T1–T2) in the right upper and lower extremities between the control and intervention groups, respectively. The sample size was calculated to be a total of 40 based on the preliminary data of 10 infants, which showed a 35% reduction in mean values of MEP amplitudes in the right adductor muscle (SD=31) with a 10% assumed dropout rate.

Ethics and dissemination
The study protocol was approved by the Institutional Review Board of the Aichi Children’s Health and Medical Center (2022058). The results will be reported in a peer-reviewed journal at the relevant academic conference.

Trial registration number
jRCT1041230094.

Introduction
Low back pain (LBP) is the leading global cause of disability. Patients with moderate to severe LBP who respond positively to a diagnostic medial nerve branch block can be offered radiofrequency denervation (RFD). However, high-quality evidence on the effectiveness of RFD is lacking.

Methods and analysis
RADICAL (RADIofrequenCy denervAtion for Low back pain) is a double-blind, parallel-group, superiority randomised controlled trial. A total of 250 adults listed for RFD will be recruited from approximately 20 National Health Service (NHS) pain and spinal clinics. Recruitment processes will be optimised through qualitative research during a 12-month internal pilot phase. Participants will be randomised in theatre using a 1:1 allocation ratio to RFD or placebo. RFD technique will follow best practice guidelines developed for the trial. Placebo RFD will follow the same protocol, but the electrode tip temperature will not be raised. Participants who do not experience a clinically meaningful improvement in pain 3 months after randomisation will be offered the alternative intervention to the one provided at the outset without disclosing the original allocation. The primary clinical outcome will be pain severity, measured using a pain Numeric Rating Scale, at 3 months after randomisation. Secondary outcomes will be assessed up to 2 years after randomisation and include disability, health-related quality of life, psychological distress, time to pain recovery, satisfaction, adverse events, work outcomes and healthcare utilisation. The primary statistical analyses will be by intention to treat and will follow a prespecified analysis plan. The primary economic evaluation will take an NHS and social services perspective and estimate the discounted cost per quality-adjusted life-year and incremental net benefit of RFD over the 2-year follow-up period.

Ethics and dissemination
Ethics approval was obtained from the London—Fulham Research Ethics Committee (21/LO/0471). Results will be disseminated in open-access publications and plain language summaries.

Trial registration number
ISRCTN16473239.

Introduction
Patent ductus arteriosus (PDA) is the most common cardiovascular problem that develops in extremely preterm infants and is associated with poor clinical outcomes. Uncertainty exists on whether early pharmacotherapeutic treatment of a clinically symptomatic and echocardiography-confirmed haemodynamically significant PDA in extremely preterm infants improves outcomes. Given the wide variation in the approach to PDA treatment in this gestational age (GA) group, a randomised trial design is essential to address the question. Before embarking on a large RCT in this vulnerable population, it is important to establish the feasibility of such a trial.

Methods and analysis
Design: a multi-centre, open-labelled, parallel-designed pilot randomised controlled trial.
Participants: preterm infants born

New England Journal of Medicine, Volume 391, Issue 4, Page 373-375, July 25, 2024.

Introduction
Breastfeeding is associated with many health benefits for both women and their newborns. Exclusive breastfeeding has been recommended for at least 6 months to optimise infant growth, development and health. In addition to standard care, community-based peer support is recommended to help mothers improve breastfeeding. A recent survey reveals that the rate of exclusive breastfeeding at 6 months post partum in Hong Kong is low, and half of all breastfeeding mothers never exclusively breastfeed. Taking into account the local practice for women to stay home during the first month post partum and social isolation during and post-COVID-19 pandemic, a home-based peer support programme with the aid of Zoom or Facetime is proposed. This study aims to evaluate the effectiveness of a home-based breastfeeding peer support programme in improving breastfeeding practices and achieving exclusive breastfeeding rate among women with low breastfeeding self-efficacy.

Methods and analysis
The study is a two-armed randomised control trial and will include a total of 442 participants. Potential cases will be recruited and screened at four postnatal wards in Hong Kong public hospital. Eligible and consented cases will be randomly allocated into intervention or control groups at a 1:1 ratio. Control group (n=221) will receive standard care, while the intervention group (n=221) will receive home-based peer support as well as standard care. Trained peer counsellors will provide breastfeeding-related support through Zoom or Facetime at 10 days and 1 month post partum. Telephone follow-ups will be conducted at 1 month, 2 months, 3 months and 6 months post partum. Breastfeeding status, mother’s breastfeeding self-efficacy and postpartum depression will be assessed and compared between the two arms.

Ethics and dissemination
The study has been reviewed and approved by the Institutional Review Board of the University of Hong Kong and Hospital Authority Hong Kong West Cluster (UW 20-564). The findings will be updated in trial registries and disseminated in peer-reviewed journals and academic conferences.

Trial registration number
NCT04621266.

Introduction
Stiff neck is a condition mainly characterised by persistent pain and limited neck movement, which can substantially impact patients’ daily lives during acute episodes. Accordingly, rapid pain relief and restoration of normal activities are the main needs of patients during doctor visits. This study aims to assess the immediate efficacy of acupuncture combined with active exercises in rapidly relieving pain and improving movement disorders within 10 min in patients with acute stiff neck (ASN).

Methods and analysis
This randomised controlled clinical trial is being conducted at a single centre in China. 120 participants diagnosed with ASN will randomly be assigned in a 1:1:1 ratio to one of three groups: the acupuncture combined with active exercise group (group A), sham acupuncture combined with active exercise group (group B) and active exercise only group (group C). Each participant will undergo a single 10 min session. The primary outcome is the effective rate at 10 min of treatment. Secondary outcomes include the effective rate at other time points (0–1, 2, 4, 6 and 8 min), Visual Analogue Scale score and cervical range of motion. The intention-to-treat analysis will include all randomised participants.

Ethics and dissemination
Ethics approval was obtained from the Ethics Committee of the Second Affiliated Hospital of Yunnan University of Chinese Medicine (2022-009). Written informed consent will be obtained from all participants before randomisation. The findings of this study will be disseminated through publication in a peer-reviewed journal and presentation at conferences.

Trial registration number
ChiCTR2200066997.

Objectives
To explore how people perceive three different forms of advice for acute low back pain (LBP).

Design
Content analysis of qualitative data collected in a three-arm randomised experiment.

Participants
2200 participants with acute LBP (ie, pain duration for ≤6 weeks) were randomly assigned to receive three types of advice: guideline advice and guideline advice with the addition of either brief pain science or ergonomics messages.

Primary and secondary outcomes
After receiving the advice, participants answered two questions: ‘If your health professional gave you this advice, how would it make you feel?’ and ‘If your health professional gave you this advice, what treatments (if any) do you think you would need?’ Two researchers coded responses using deductive content analysis.

Results
We analysed 4400 free-text responses from 2200 participants. There were little to no differences in participants’ feelings, thoughts and expectations after receiving three types of advice for acute LBP. Participants most commonly expressed feeling positive about the advice (38%–35%), reassured (23%–22%) and empowered (10%–8%). Some expressed being unhappy or being frustrated with the advice (4%–3%). Participants most commonly thought they needed no treatment apart from staying active, followed by exercise and medication.

Conclusions
Guideline advice with or without the addition of brief pain science or ergonomics messages generated positive feelings, reassurance or a sense of empowerment in many people with acute LBP, with no difference between types of advice.

Trial registration number
ACTRN12623000364673.

This Review discusses whether treatment with low-dose corticosteroids may benefit critically ill patients with respiratory infections who have septic shock, acute respiratory distress syndrome, or both.

Introduction
Rotator cuff-related shoulder pain (RCRSP) is the most common cause of shoulder pain. Currently, exercise is proposed as the first-line treatment for patients suffering from RCRSP. However, adherence to therapeutic exercise programmes can be poor in the long term in a home setting. The aim of this study is to evaluate the effects of adding video animations to a traditional paper-based exercise programme.

Methods and analysis
A single-centre, randomised, open-labelled clinical trial will be conducted in a hospital in Spain. Adults aged between 18 and 80 years diagnosed with RCRSP who meet the eligibility criteria will be included. Patients (n=132) will be randomised into two groups, with both receiving paper-based exercises, and the experimental group will also be provided with video animations. The participants will receive seven face-to-face physical therapy sessions and will be asked to perform the exercises at home for 6 months. The primary outcome measure will be the Shoulder Pain and Disability Index, measured at baseline, 3 weeks, 3 months (primary analysis) and 6 months. Secondary outcomes will be the patient’s pain intensity during the last week (rest, during movement and at night); expectations of improvement; satisfaction with treatment; impression of improvement; perceived usability, usefulness and satisfaction of multimedia animations; and adherence to exercises. Generalised least squares regression models with an autoregressive-moving average lag one correlation structure will be implemented, with an intention-to-treat analysis.

Ethics and dissemination
This study has been approved by the ethics committee of Hospital Universitario Fundación Alcorcón (Madrid, Spain), reference number CI18/16. All participants will sign an informed consent. The results will be published in a peer-reviewed scientific journal.

Trial registration
ClinicalTrials.gov, NCT05770908.

New England Journal of Medicine, Volume 391, Issue 3, Page 260-271, July 18, 2024.

Introduction
Methods and validated tools for evaluating the performance of competency-based implementation research (IR) training programmes in low–middle-income countries (LMICs) are lacking. In this study, we developed tools for assessing the performance of IR training programmes based on a framework of IR core competencies in LMICs.

Methods
We developed self-assessment and objective-assessment tools drawing on the IR competency framework. We used exploratory factor analyses and a one-parameter logistic model to establish construct validity and internal consistency of the tools drawing on a survey conducted in 2020 with 166 trainees before and after an index IR course across five universities and LMICs under the Special Program for Research and Training in Tropical Diseases postgraduate IR training scheme. We conducted key informant interviews (KII) with 20 trainees and five trainers to reflect on the usefulness of the tools and framework for guiding IR training in LMICs.

Results
Two 16-item tools for self-assessment of IR knowledge and self-efficacy and a 40-item objective assessment tool were developed. The factor loadings of items in the self-assessment tools were 0.65–0.87 with Cronbach’s alpha (α) of 0.97, and 0.77–0.91 with α of 0.98 for the IR knowledge and self-efficacy tools, respectively. The distribution of item difficulty in the objective-assessment tool was consistent before and after the index IR course. Pearson correlation coefficient (r) between the self-assessed and objectively assessed IR knowledge before the index IR course was low, r=0.27 (p value:

Six sessions of guidance by a physical therapist nearly doubled time to back-pain recurrence.

Introduction
Osteoarthritis (OA) is the most common joint disorder among musculoskeletal conditions. Non-surgical treatment is the standard therapy for knee OA (KOA). Ultrasound therapy is recommended for alleviating pain and dysfunction from OA, but high-quality scientific evidence for its effectiveness in OA treatment is still lacking.Therefore, we want to analyse whether combining conventional physical therapy with low-intensity pulsed ultrasound (LIPUS) can enhance the efficacy of conventional therapy, thus improving symptoms in patients with KOA.

Methods and analysis
This randomised controlled trial aims to recruit 200 patients diagnosed with KOA, aged 38 years or above, who meet the clinical diagnostic criteria for KOA. Patients will be randomly assigned in a 1:1 ratio to either a LIPUS treatment group or a sham ultrasound treatment control group. The 2-week treatment will consist of five sessions per week and evaluations will take place at baseline, on the day of the last intervention and 1 month post intervention. The main outcome measures will be the Western Ontario and McMaster Universities’ scores. Secondary outcome indicators will be the Numerical Pain Rating Scale, the Lequesne scale, the time up and go test and the range of motion of the knee. An intention-to-treat analysis will be performed for dropouts and missing data.

Ethics and dissemination
The study was approved by the ethics committee of Shengjing Hospital of China Medical University (2023PS592K). Findings will be disseminated to participants and made available to peer-reviewed journals.

Trial registration number
The trial was registered on the Chinese Clinical Trial Registry platform (chictr.org.cn) on 22 March 2023, with the registration ID ChiCTR2300069643.

Current guidelines recommend that people with endometriosis use hormone therapies such as a combined oral contraceptive pill (COCP) or progestogens to manage pain associated with the condition. Now, new research published in The BMJ suggests that progestogen might be a better choice than COCPs for people seeking to minimize pain as well as lower their need for future surgeries.