Background: Myopia has emerged as a major threat to the visual health of adolescents worldwide. Early intervention can effectively slow down the progression of myopia in adolescents. Tuina (also known as Tui Na), a significant therapeutic method in traditional Chinese medicine, has shown promising clinical efficacy in delaying the progression of myopia; however, it lacks robust, large-scale, and standardized randomized controlled trials.
Objective: This study aims to explore the efficacy and safety of tuina therapy in managing myopia in adolescents, thereby providing solid evidence for the application of tuina in the clinical treatment of myopia.
Methods: This study is a multicenter randomized controlled clinical trial. A total of 62 children with myopia will be recruited from 4 hospitals and randomly assigned in a 1:1 ratio to a tuina experimental group and a drug-positive control group (tropicamide eye drops). Treatments in each group will be administered 3 times per week for a total of 8 weeks. The tuina experimental group will receive 20 minutes of tuina therapy per session, while the drug-positive control group will receive tropicamide eye drops administered every other day, with 2 drops per session. The primary outcome measures include uncorrected visual acuity and axial length, while secondary outcome measures include refractive power and accommodative amplitude. Data will be collected at baseline (week 0), on the day of completion of weeks 4 and 8 of treatment, and at the end of the 10-week follow-up period. Adverse events will be monitored and recorded throughout the study. Statisticians will be blinded. Data will be analyzed using SPSS version 28.0.
Results: This study has been funded, and recruitment began in June 2025. As of December 2025, 29 participants have been enrolled, with 16 allocated to the tuina group and 13 to the drug-positive control group. Recruitment is expected to continue until October 2026. Final manuscript submission is anticipated by December 2026.
Conclusions: This study aims to evaluate the efficacy and safety of tuina therapy in the treatment of adolescents with myopia. We hypothesize that the therapeutic effect of tuina therapy is noninferior to that of tropicamide eye drops, with the additional advantages of fewer side effects and stable long-term efficacy, thereby providing reliable evidence and support for the application of tuina therapy in the management of myopia in adolescents.
Background: Myofascial pain remains an underdiagnosed contributor to musculoskeletal pain conditions, including plantar heel pain, which is the most common source of foot pain. The current standard for diagnosing myofascial pain is a clinical examination using manual palpation. However, this approach lacks quantitative thresholds for precise assessment of myofascial pain, highlighting the need for validated biomarkers.
Objective: This protocol describes the development of a diagnostic imaging biosignature of myofascial pain using both ultrasound and magnetic resonance imaging to differentiate individuals with plantar heel pain from those with other kinds of foot pain and matched pain-free controls. The study will also explore whether diagnostic accuracy is enhanced by creating a composite biosignature that includes psychological factors.
Methods: In this cross-sectional study, 100 participants will be recruited: 50 with plantar heel pain, 25 with insertional Achilles tendinopathy, and 25 pain-free controls. Participants will undergo a clinical examination of 5 calf and foot muscles to identify sites of abnormal myofascial tissue. The primary imaging outcomes will capture biochemical properties (T1ρ of muscle and fascia), biomechanical properties (shear wave speed of the muscle, shear strain of the plantar fascia during passive movement), and structural profile (fat fraction of the muscle, thickness of the plantar fascia). Patient-reported outcomes will include the National Institutes of Health's Helping to End Addiction Long-term (HEAL) Initiative Common Data Elements and additional psychological measures.
Results: This study is supported by grant R61AT012275 from the National Center for Complementary and Integrative Health and the National Institute of Neurological Disorders and Stroke, awarded in September 2024. Participant enrollment began in May 2025. As of November 2025, a total of 55 participants have been enrolled. Enrollment is expected to conclude no later than July 2026. The anticipated study completion date is August 2026. Data will be shared within 1 year of completing the study or upon publication, whichever occurs first.
Conclusions: This protocol provides novel mechanistic insight into myofascial pain through advanced imaging techniques, offering a biopsychosocial framework for improving the diagnosis and treatment of plantar heel pain and related conditions. We anticipate that combining imaging and psychosocial measures will improve the diagnostic accuracy of the biosignature and provide a more comprehensive understanding of myofascial pain.
Trial registration: ClinicalTrials.gov NCT06803056; https://clinicaltrials.gov/study/NCT06803056; OSF Registries osf.io/nxqfj; https://osf.io/nxqfj.
International registered report identifier (irrid): DERR1-10.2196/87613.
Background: Autism spectrum disorder (ASD) represents a significant public health challenge characterized by persistent social communication deficits and restricted, repetitive patterns of behavior. Current interventions show limited efficacy, particularly for core symptoms. Repetitive transcranial magnetic stimulation (rTMS) and auditory integration training (AIT) have independently demonstrated promise in addressing neurophysiological abnormalities associated with ASD.
Objective: This study aims to evaluate the clinical efficacy of a combined rTMS and AIT intervention compared to rTMS alone and sham stimulation in children with ASD.
Methods: This is a randomized, sham-controlled trial that will recruit 80 children aged 2 to 6 years with a confirmed ASD diagnosis. The randomization of the first 8 participants in this study used a 1:1:1 ratio. To more effectively test the core hypothesis (ie, the efficacy of the combined intervention), greater statistical power will be concentrated on the intervention group (rTMS+AIT), and the randomization ratio was ultimately adjusted to 2:1:1-specifically, (1) rTMS combined with AIT (n=40), (2) rTMS alone (n=20), or (3) sham rTMS (n=20). Primary outcome measures include the Autism Behavior Checklist and Childhood Autism Rating Scale. Secondary outcomes are the Strengths and Difficulties Questionnaire and Repetitive Behavior Scale-Revised. Assessments will be conducted at baseline, an interim time point, and immediately after the intervention. Data will be analyzed using SPSS (version 25.0; IBM Corp).
Results: This study has received funding, with data collection commencing in April 2024. Due to the small initial sample size of 8 participants (5 male and 3 female), no formal statistical comparisons of baseline characteristics between groups have been conducted at this time. It is anticipated that the rTMS combined with AIT intervention will exhibit superior efficacy compared to rTMS only.
Conclusions: This will be the first sham-controlled trial to systematically investigate the potential synergistic effects of a combined rTMS and AIT intervention in children with ASD. The results will provide valuable insights into the neurotherapeutic potential of this combined approach and contribute to the development of evidence-based interventions for ASD.
Background: The increasing prevalence of severe obesity among youth and the early onset of comorbidities highlight the urgent need for effective solutions to support behavior and lifestyle changes. Motivational interviewing (MI), a client-centered counseling technique, has shown promise in improving obesity-related outcomes and is now recommended by the American Academy of Pediatrics as a key component of behavioral interventions for children with overweight and obesity.
Objective: This study aimed to describe the design and baseline characteristics of the Wellness Coaching for Kids and Families (WC4K) program, an MI-based behavioral health intervention integrated into pediatric primary care within a large integrated health care system. This trial aims to inform broader implementation strategies for other health care systems.
Methods: We are conducting a cluster randomized pragmatic trial across 50 pediatric clinics within Kaiser Permanente Southern California. Clinics were randomized to either the intervention arm (n=24, 48.00%) or the usual care arm (n=26, 52.00%), targeting children aged between 3 and 8 years with overweight or obesity. Pediatricians in intervention clinics received MI training and referred families to centralized health coaches for tailored telephone counseling. Key behavioral targets include increased fruit and vegetable intake, reduced consumption of sugar-sweetened beverages, increased physical activity, and reduced screen time. The primary outcome is a change in BMI-for-age, measured as relative distance from the median using electronic medical record data. Secondary outcomes include parent-reported behavior change indicators.
Results: The source population includes 150,482 children from clinics serving predominantly low-income and racial and ethnic minority populations. After randomization, intervention and control clinics were similar in demographics (standardized mean differences <0.2 for key variables), with 77,481 (51.49%) children in the WC4K intervention clinics and 73,001 (48.51%) children in the control clinics. In the total clinic population, 36.58% (55,052/150,482) of the children were overweight or with obesity. Enrollment started in fall 2022, study results are expected in spring 2027.
Conclusions: If the trial results indicate success in reducing BMI and improving health behaviors, WC4K may offer a scalable and sustainable model for integrating behavioral health coaching into pediatric primary care. By leveraging MI-trained pediatricians and centralized health coaching, WC4K has the potential to facilitate meaningful lifestyle changes in children with overweight or obesity.
Trial registration: ClinicalTrials.gov NCT05143697; https://clinicaltrials.gov/study/NCT05143697.
International registered report identifier (irrid): DERR1-10.2196/78792.
Background: Cognitive frailty (CF), characterized by the coexistence of mild cognitive impairment and physical frailty in the absence of dementia or other neurodegenerative diseases, is a significant risk factor for dementia and functional decline in older adults. Although Du-moxibustion has shown potential benefits in improving CF, the effect of spine-pinching therapy remains underexplored.
Objective: This study aims to evaluate, for the first time, the efficacy and safety of Du-moxibustion combined with spine-pinching therapy in older adults with prefrailty and CF.
Methods: This is a prospective, single-center, randomized, single-blind, 4-arm parallel controlled trial. A total of 156 older adults with prefrailty and CF will be recruited and randomly assigned to 1 of 4 groups: routine care group, Du-moxibustion group, spine-pinching group, or combined intervention group. The intervention will last for 8 weeks. The primary outcome is the change in Montreal Cognitive Assessment score. Secondary outcomes include the Fried frailty phenotype, Barthel Index (activities of daily living), 15-item Geriatric Depression Scale, 36-item Short Form Health Survey, global frailty status, and traditional Chinese medicine syndrome scores. Outcome assessments will be performed at baseline (wk 0), midintervention (wk 6), postintervention (wk 8), and follow-up (wk 12).
Results: Recruitment for this study is scheduled to commence in March 2026 and will end in June 2027 (recruitment and intervention). All follow-up and data collection activities will be finalized by October 2027. Results are anticipated to be completed in the first quarter of 2028.
Conclusions: This study is expected to provide high-quality evidence for the clinical efficacy of Du-moxibustion combined with spine-pinching therapy in managing CF and contribute to the integration of traditional Chinese medicine external therapies in the promotion of healthy aging. Although the single-blind design may introduce expectancy bias, strict randomization procedures and standardized interventions will enhance the reliability and scientific rigor of the results.
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：