Interactive Acupuncture Dysphagia Trial Protocol
The protocol is designed to test a comparative swallowing-function question with repeated clinical and instrument-based assessments, yet it reports planned methods rather than treatment effects, safety findings, or patient benefit.
Evidence
This is a prospective, multicenter, parallel-group randomized controlled trial protocol in participants with poststroke dysphagia. The planned enrollment is 100 participants following eligibility screening, baseline assessment, and written informed consent. It compares interactive acupuncture—a procedure synchronizing short needling stimulation at selected nape acupoints with active swallowing tasks—with conventional acupuncture delivered at the same acupoints. Both groups also receive basic treatment under cerebrovascular disease prevention and treatment guidelines and local clinical practice. The protocol therefore holds the acupoint prescription and background care framework in common while varying whether stimulation is synchronized with swallowing activity. pmid:42969314
The intervention course consists of 14 treatment sessions over approximately 2 to 3 weeks, followed by a 1-month follow-up. The registered primary outcome is water swallowing test (WST) grade. The primary efficacy comparison is change in WST grade from baseline to immediately after the 14th session; assessments after sessions 3 and 7 are prespecified repeated measurements intended to characterize the response time course. For the primary analysis, investigators plan proportional odds ordinal regression of session-14 WST grade, with adjustment for baseline WST grade, study center, and prespecified clinically relevant covariates such as age and time since stroke onset. The planned effect measure is a common odds ratio with a 95% confidence interval. pmid:42969314
The protocol defines a supportive overall WST response rate at session 14 as improvement of at least one WST grade from baseline without worsening of aspiration-related clinical symptoms. Secondary measures include Standardized Swallowing Assessment score, Functional Oral Intake Scale score, Swallowing Quality of Life Questionnaire score, videofluoroscopic swallowing study findings including penetration and aspiration assessed with the Penetration-Aspiration Scale where applicable, surface electromyography parameters, infrared thermography of the pharyngolaryngeal region, and peripheral inflammatory markers including interleukin-6, tumor necrosis factor α, and C-reactive protein. The WST, Standardized Swallowing Assessment, Functional Oral Intake Scale, videofluoroscopic swallowing study, surface electromyography, infrared thermography, and inflammatory markers are clinician- or instrument-assessed; the Swallowing Quality of Life Questionnaire is participant reported, with standardized-question reading assistance and recorded caregiver assistance for participants with communication difficulty. pmid:42969314
The analysis population is intention-to-treat: randomized participants, including those who discontinue intervention or withdraw, are to be analyzed in their allocated group and are not replaced. The protocol specifies alternative ordinal models and a Mann-Whitney U test on change scores if the proportional-odds assumption is not met. The supportive response-rate comparison is planned with chi-square or Fisher exact testing and effect estimates with 95% confidence intervals. These are prospective analytic plans, rather than results. At the stated status update, 36 participants had enrolled and primary outcome data analysis had not begun. pmid:42969314
Analysis — Protocol Interpretation
The central comparison is appropriately narrow: among participants with poststroke dysphagia receiving the same-acupoint acupuncture framework and background medical care, the trial will compare an interactive, task-synchronized procedure with conventional acupuncture. Repeated WST assessments provide a specified trajectory of the primary swallowing measure, while the broader outcome set separates participant-reported swallowing-related quality of life from clinician- and instrument-assessed measures. Adjustment for baseline WST grade and study center addresses measured features built into the multicenter design; adjustment for prespecified covariates is also planned. The observed record at this stage is therefore a trial setup and enrollment status, not an observed between-group pattern. No common odds ratio, confidence interval, response-rate comparison, or other comparative outcome estimate is reported in the protocol material. pmid:42969314
The protocol’s mechanistic framing remains a hypothesis: it describes the possibility that time-locked peripheral stimulation and swallowing tasks may facilitate sensory-motor integration, while explicitly stating that this requires further mechanistic validation beyond clinical outcomes. The collection of surface electromyography, thermography, and peripheral inflammatory markers can characterize prespecified physiological indicators within this trial, but these measures do not themselves establish a mechanism. Likewise, a planned WST responder definition identifies a supportive analysis and its denominator concept—the proportion of participants meeting the defined response criterion—but does not provide a result. The appropriate interpretation is limited to the planned randomized comparison and its specified measurement strategy. pmid:42969314
Limitations
The protocol reports that participants and practitioners cannot be fully blinded. This creates potential for expectations or treatment-delivery differences to influence experiences and procedures not fully protected by blinding, even though the discussion describes blinded outcome assessment as a design emphasis. The provided material does not report completed outcome analyses, comparative safety results, or estimates of uncertainty around treatment effects. Accordingly, the protocol cannot establish whether the groups differed in swallowing outcomes, physiological indicators, or safety outcomes. pmid:42969314
The planned sample size is powered for the primary swallowing outcome rather than mechanistic indicators, limiting what the trial may resolve for the latter measures. The article also describes low-certainty evidence, intervention heterogeneity, and incomplete reporting in prior acupuncture literature for poststroke dysphagia; those observations provide context for the protocol’s manualized and fidelity-monitored approach but are not findings from the current trial. Eligibility screening, withdrawals, and the conduct of care across participating centers may shape the ultimately analyzed population and comparison, so interpretation of any future results will depend on the completed participant flow, intervention fidelity, missing-data handling, and reported estimates. pmid:42969314