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US multicentre randomised controlled trial protocol: Comparing Analgesic Regimen Effectiveness and Safety after surgery trial for Kids (CARES for Kids)

Por: Lee · J. S. · Bicket · M. C. · Mansfield · S. A. · Rabbitts · J. A. · Van Horn · A. · Perrone · E. E. · Chua · K.-P. · Voepel-Lewis · T. · Waljee · J. · Brummet · C. · Hutmacher · C. · Li · Y. · Kelley-Quon · L. I. · CARES for Kids Investigators · Bicket · Kelley-Quon · Brummett · Ch
Introduction

Acute pain is an expected symptom for adolescents after outpatient surgery. In the USA, postoperative analgesic regimens frequently include prescription opioids. Increasing attention from clinicians, patients and other healthcare leaders has been directed toward non-opioid strategies, such as combining non-steroidal anti-inflammatory drugs (NSAIDs) plus acetaminophen, as potential first-line options for managing postoperative pain. However, the effectiveness and safety of home regimens that include versus exclude opioids for adolescents are unclear. The Comparing Analgesic Regimen Effectiveness and Safety after surgery for Kids study evaluates the effectiveness and safety of NSAIDs plus acetaminophen alone (NSAID regimen) versus NSAIDs and acetaminophen plus a low-dose opioid regimen (opioid regimen).

Methods and analysis

This study is a pragmatic, multicentre randomised controlled clinical trial recruiting 900 patients aged 12–20 years undergoing three common outpatient surgeries (tonsillectomy, laparoscopic cholecystectomy, knee arthroscopy) across four health systems. We will recruit patients prior to surgery and individuals will be randomised 1:1 with stratification to receive prescriptions for either the NSAID regimen or the opioid regimen. The primary effectiveness outcome is patient-reported pain intensity, while the primary safety outcome is adverse medication-related symptoms both assessed over the first 2 weeks after surgery. Secondary outcomes include quality of recovery, healthcare-related quality of life and rates of problematic substance use and chronic prescription opioid use, assessed up to 1 year after surgery.

Ethics and dissemination

The study incorporates stakeholder collaboration, including patient partners, surgeons, professional organisations., and health insurance payors, to ensure ethical conduct and relevance. This study is overseen by a single institutional review board with certificate of confidentiality. Findings will be disseminated through academic publications, conferences and community outreach to inform patients, parents, surgical teams and policymakers about optimal pain management strategies for adolescents after surgery.

Trial registration number

NCT06671002.

Cortical-multifidus paired associative stimulation for improving motor function in patients with chronic low back pain: study protocol for a randomised controlled trial

Por: Lu · H. · Shao · Q. · Guo · J. · Huang · Z. · Cao · Y.-j. · Li · F. · Li · W. · Xiong · W. · Li · K.-P. · Feng · W.
Introduction

Chronic low back pain (CLBP) is characterised by multifaceted pathophysiology involving both central sensitisation and peripheral dysfunction. Conventional therapies often fail to address this complexity due to their unidimensional targets. Paired associative stimulation (PAS), a dual-target neuromodulatory approach that combines central and peripheral interventions, has demonstrated efficacy in enhancing motor recovery post-stroke by synchronously inducing corticospinal plasticity and peripheral neuromuscular adaptation. Building on this paradigm, we propose a novel combined primary motor cortex (M1) and multifidus muscle stimulation protocol. The intervention pairs transcranial magnetic stimulation over M1 with peripheral magnetic stimulation targeting the multifidus muscle, hypothesising that temporally coordinated central and peripheral stimulation will synergistically enhance the corticospinal drive to the lumbar spine and restore multifidus neuromuscular control, thereby alleviating pain and improving functional capacity in CLBP.

Methods and analysis

This study will enrol 82 individuals diagnosed with CLBP between 18 and 65 years of age. Study participants will undergo randomisation into two parallel groups: the experimental arm receiving active PAS therapy (n=41) and the control arm receiving sham PAS treatment (n=41). The intervention protocol consists of 20 treatment sessions delivered across a 4-week timeframe, with participants attending five sessions weekly. Assessment time points are scheduled at study entry (baseline) and 4, 8 and 12 weeks following intervention initiation. The study’s primary outcome is the Oswestry Disability Index (ODI). Secondary outcomes encompass the Visual Analog Scale (VAS), Short-form McGill Pain Questionnaire (SF-MPQ), Short Form 36 Health Survey (SF-36), Pain Catastrophizing Scale (PCS), and functional magnetic resonance imaging (fMRI). Data analysis will adhere to the intention-to-treat methodology. Between-group comparisons across temporal measurement points will employ mixed-effects modelling approaches.

Ethics and dissemination

Ethical approval for the research protocol was obtained from the Ethics Committee of Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (approval number: 2025-K-45), with trial registration completed in the China Clinical Trial Registry on 27 April 2025. On study completion, findings will be prepared for submission to peer-reviewed academic publications.

Trial registration number

ChiCTR2500101574.

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