Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 20, 2025
Open Peer Review Period: Aug 20, 2025 - Oct 15, 2025
Date Accepted: Dec 12, 2025
(closed for review but you can still tweet)
Effect of Du-moxibustion Combined with Spine-pinching Therapy on Cognitive Frailty in Older Adults with Prefrailty: A Randomized Controlled Trial Protocol
ABSTRACT
Background:
Cognitive frailty, characterized by the coexistence of mild cognitive impairment (MCI) 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 cognitive frailty, 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 cognitive frailty.
Methods:
This is a prospective, single-center, randomized, single-blind, four-arm parallel controlled trial. A total of 160 older adults with prefrailty and cognitive frailty will be recruited and randomly assigned to one of four groups: routine care group, Du-moxibustion group, spine-pinching group, or combined intervention group. The intervention will last for 8 weeks. The primary outcomes are changes in Montreal Cognitive Assessment (MoCA) scores and Fried frailty phenotype scores. Secondary outcomes include Barthel Index (activities of daily living), Geriatric Depression Scale-15 (GDS-15), Short Form Health Survey (SF-36), global frailty status, and Traditional Chinese Medicine (TCM) syndrome scores. Outcome assessments will be conducted at baseline (week 0), mid-intervention (week 6), post-intervention (week 8), and follow-up (week 12).
Results:
Recruitment began in March 2026 and ended in June 2027 ( recruitment and intervention ). Data collection will end in October 2027 and results are expected in early 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 cognitive frailty 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. Clinical Trial: International Traditional Medicine Clinical Trial Registry ITMCTR2025001589 https://itmctr.ccebtcm.org.cn/
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