Chronic musculoskeletal pain (CMP) is a leading cause of incurred personal healthcare costs and disability in the USA. It disproportionately affects rural populations, who are more likely to be uninsured, lack access to a regular healthcare provider and experience a higher prevalence of CMP. As a result of reduced access to non-pharmacological care, there is greater reliance on opioids. The Auricular Point Acupressure – Self-Management (APA-SM) program is a simple, needleless, evidence-based therapy that empowers individuals to self-manage their pain. Preliminary studies, including a recent UG3 pilot testing, demonstrated feasibility, safety and significant improvements in pain and function. Guided by Bandura’s self-efficacy model and informed by stakeholder input, APA-SM integrates a smartphone application, ecological momentary assessment and personalized motivational messaging to enhance adherence and behavior change. This study protocol describes the design of a real-world, hybrid effectiveness-implementation, randomized controlled trial to evaluate the clinical impact and sustainability of APA-SM in rural settings.

We will conduct a pragmatic, three-arm randomized controlled trial in Texas and South Carolina, enrolling 693 adults with CMP (231 per group). Participants will be randomized to: (1) APA-SM with remote training, (2) APA-SM with in-person training or (3) education control. The primary outcome is pain impact measured by the PEG (composite score of pain intensity, interference on enjoyment of life, and general activity) scale at immediate post-intervention (4 weeks), with follow-up at 1, 3 and 6 months. Secondary outcomes include National Institutes of Health Helping to End Addiction Long-Term Clinical Pain Core common data elements (eg, psychological functioning, disability, sleep, quality of life), opioid use and patient-reported adherence and satisfaction. Implementation outcomes will be assessed at both the patient and provider levels, guided by the RE-AIM framework. Cost-effectiveness will be estimated using implementation costs and incremental cost-effectiveness ratios, and predictive factors for APA-SM treatment response will be identified using statistical machine learning approaches and historical electronic health record data. The target sample size (231 per group) provides 90% power to detect a moderate effect size (Cohen’s d=0.35), accounting for 25% attrition. Randomization occurs at the participant level to reflect real-world delivery and minimize contamination.

This study, sponsored under grant number 4UH3AT012728, has single Institutional Review Board (IRB) approval at UTHealth Houston, Texas, USA (HSC-SN-25-0443). A Data Safety Monitoring Board will oversee adverse event reporting and trial conduct. Dissemination will occur through peer-reviewed publications, conference presentations, stakeholder workshops and community-based reports tailored for rural health systems and policymakers.

This trial will provide the first large-scale evaluation of APA-SM in rural U.S. populations, integrating digital health tools and implementation science methods to help address disparities in pain management. By assessing clinical effectiveness, implementation outcomes, cost-effectiveness and predictive response factors, study results will inform scalable strategies for integrating APA-SM further into rural communities and healthcare systems. If successful, APA-SM has the potential to improve pain care access, reduce opioid reliance and provide a sustainable, patient-centered model for chronic pain management.

NCT07179016.

To identify the assessments, diagnostic criteria and outcome measures reported in peer-reviewed literature for children with growing pains and persistent lower limb pain in the presence of restless leg syndrome (RLS).

Scoping review completed in line with Joanna Briggs Institute methodological guidance

Five online databases were searched—MEDLINE, Embase, CINAHL, PsycINFO and AMED—for records up to 14 October 2024.

Records reporting on the use of assessments, diagnostic criteria or outcome measures in children (aged 0–18 years) with growing pains or persistent lower limb pain in the presence of RLS. Articles were required to have a sample size of ≥10 and be available in English language.

Data were extracted by two independent reviewers and analysed using descriptive statistics.

Following review of 19 806 records, 61 unique records were included. Most were observational cross-sectional or case–control designs. Assessments were varied and primarily focused on body functions and pain characteristics rather than activities and participation. There were 15 unique diagnostic criteria reported for growing pains with limited consistency and sometimes conflict between included items. Outcomes measures were only reported in eight records and typically measured pain presence and intensity.

Assessment and subsequent diagnosis of growing pains and persistent pain in the presence of RLS lack consistency. Outcome measures were seldom used as most records were not designed to measure change over time. Standardised practices for assessment and management of these conditions may benefit clinicians and optimise patient care.

Many cancer treatments can result in reduced fertility, impacting survivors’ opportunities for biological parenthood. Fertility preservation (FP) methods for boys and young men, such as cryopreservation of testicular tissue or sperm, offer hope but are currently underused among young male patients with cancer. Despite guidelines recommending early discussion of fertility implications, many newly diagnosed males do not receive FP counselling or referral to fertility services. Male cancer survivors face a higher likelihood of infertility than their peers, yet focused FP decision-making support is lacking. This study aims to address this gap by developing and evaluating the first dedicated patient decision aid (PtDA) for boys and young male patients with cancer aged 11–25 years old, to help them make informed FP decisions before receiving cancer treatment.

The current study follows a multistage process: developing the PtDA, alpha testing for acceptability with former patients, parents and healthcare professionals, and beta testing in clinical settings to ensure effective integration into routine care. Using a combination of interviews and questionnaire data, this research will assess the PtDA’s acceptability and impact on decision-making.

This study has been prospectively registered on the Research Registry (10273). Ethics approval has been obtained from Leeds Beckett University and the National Health Service/Health Research Authority before undertaking data collection. The final resource will be disseminated widely and made freely available online via our dedicated Cancer, Fertility and Me website, for use in clinical and research practice.

Digital health interventions (DHIs) are prevalent and have been shown to help some people with long-term conditions (LTCs) to manage their condition. There are myriad options for digital delivery yet limited understanding of what modes of delivery are acceptable to people with LTCs. It is important to understand the acceptability of delivery methods of DHIs to inform future DHI development and promote engagement. This scoping review aims to explore the acceptability of the delivery of DHIs for people with LTCs.

This review will follow the Joanna Briggs Institute guidance for scoping reviews and will be reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Scoping reviews extension checklist. Databases including MEDLINE, PubMed, CINAHL, AHMED and PsycINFO will be searched for primary studies that provide data on preferences for delivery methods of DHIs by people with LTCs. Narrative analysis is anticipated, and a summary of the findings will be presented in a tabulated format.

Ethical approval will not be required for this scoping review. The findings will be disseminated via appropriate peer-reviewed journals and conferences and PhD theses.