Cardiovascular

Interactive Acupuncture for Poststroke Dysphagia: Protocol for a Randomized Controlled Trial.

TL;DR

This protocol describes a multicenter, parallel-group randomized controlled trial of 100 patients that will test whether interactive acupuncture (nape acupoint needling synchronized with active swallowing tasks) improves swallowing function more than conventional acupuncture at the same acupoints in poststroke dysphagia; no efficacy results are reported yet.

Key Findings

The trial is designed as a multicenter, parallel-group randomized controlled trial comparing interactive acupuncture with conventional acupuncture at the same acupoints in poststroke dysphagia.

  • A total of 100 participants with poststroke dysphagia will be randomized 1:1 to an interactive acupuncture group or a conventional acupuncture control group.
  • Both groups will receive routine conventional medical care and standardized acupuncture therapy for stroke.
  • The trial aims to determine whether adding a task-synchronized interactive procedure to the same acupoint prescription gives incremental benefit.

Interactive acupuncture is defined as short needling stimulation at selected nape acupoints synchronized with active swallowing tasks.

  • It is described as a dynamic acupuncture procedure.
  • The control group receives conventional acupuncture at the same acupoints, so the difference lies in the task-synchronized, interactive element.
  • The protocol is described as manualized and fidelity-monitored for future clinical implementation.

The intervention course consists of 14 sessions delivered 6 times per week, followed by a 1-month follow-up.

  • Outcomes will be assessed at baseline; after sessions 3, 7, and 14; and at 1 month after treatment completion, where applicable.

The registered primary outcome is the water swallowing test (WST) grade, with the primary efficacy comparison being change in WST grade from baseline to immediately after the 14th session.

  • A supportive WST responder analysis is also planned as a secondary outcome.

Secondary outcomes cover clinical, patient-reported, instrumental, physiological, inflammatory, and safety measures.

  • Secondary outcomes include the Standardized Swallowing Assessment, Functional Oral Intake Scale, and Swallowing Quality of Life Questionnaire.
  • Instrumental and physiological assessments, inflammatory markers, and safety outcomes are also included.

Rationale: poststroke dysphagia is common and disabling with serious consequences, and conventional rehabilitation and instrumental assessment have accessibility limitations.

  • Poststroke dysphagia is associated with malnutrition, aspiration pneumonia, impaired quality of life, and mortality.
  • Conventional swallowing rehabilitation and instrumental assessment may be limited by equipment dependence and inconsistent accessibility.

Regulatory approvals, registration, and funding are in place, and recruitment is ongoing.

  • The amended protocol was approved by the Medical Ethics Committee of Hengshui Hospital of Traditional Chinese Medicine (approval 2026-KY-09); separate approval was obtained from the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine (Y2025-053-01).
  • The study was funded in June 2025 and registered with the International Traditional Medicine Clinical Trial Registry on December 30, 2025.
  • Recruitment began January 1, 2026; as of July 6, 2026, 36 participants had been enrolled.

No efficacy results are available; primary outcome analysis has not begun, and the timeline extends to 2027.

  • Recruitment is expected to continue until June 1, 2027.
  • Final follow-up is anticipated by July 2027.
  • Submission of primary results is planned for September 2027.

What This Means

This paper describes the plan for a clinical trial rather than reporting results. The trial will test a new style of acupuncture, called interactive acupuncture, for people who have trouble swallowing after a stroke. In this approach, brief needling at points on the back of the neck is timed to coincide with the patient actively swallowing. It will be compared with standard acupuncture at the same points, to see whether the timing with swallowing adds any extra benefit. The study plans to enroll 100 patients, randomly assigned to one of the two acupuncture approaches, with everyone also receiving usual medical care. Each person will have 14 sessions, six per week, and be followed for one month afterward. The main measure is a simple water swallowing test graded before and after treatment. Other measures include swallowing assessments, quality of life questionnaires, instrument-based tests, blood inflammation markers, and safety. Recruitment started in January 2026, and 36 people had enrolled by July 2026. No results exist yet; they are expected to be submitted in September 2027. This research suggests that, once complete, the trial may clarify whether this type of task-synchronized acupuncture is worth using beyond conventional acupuncture, and the protocol is designed to make the method standardized enough for others to replicate.

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Citation

Zhao Z, Li J, Zhao M, Shao C, Xu M, Zhang Y, et al.. (2026). Interactive Acupuncture for Poststroke Dysphagia: Protocol for a Randomized Controlled Trial.. JMIR research protocols. https://doi.org/10.2196/102785