Clinical efficacy and neural mechanisms of Tuina for primary dysmenorrhea with cold congestion and blood stasis pattern: a protocol for a randomized controlled fMRI trial.

Background: Primary dysmenorrhea (PD) is one of the most common gynecological disorders in women of reproductive age and significantly impairs quality of life. Epidemiological data indicate that the cold congestion and blood stasis pattern accounts for a large proportion of PD cases. Tuina, a traditional Chinese external therapy, has unique advantages in pain management; however, its clinical efficacy and central mechanisms for PD remain unclear. Objective: This study aims to conduct an assessor-blind, parallel-group randomized controlled superiority trial, integrating functional magnetic resonance imaging (fMRI), to evaluate the clinical efficacy, safety, and central brain network modulation of Tuina therapy for primary dysmenorrhea with the cold congestion and blood stasis pattern. Methods: This study employed a randomized controlled trial design. A total of 54 patients who met the diagnostic criteria were recruited and randomly assigned in a 1:1 ratio to either the treatment or control group. An additional 15 healthy women were included as the healthy group. Participants in the treatment group received standardized manipulation over two consecutive menstrual cycles. For each cycle, treatment began 7 days before menstruation and was administered once daily for 7 consecutive days. Participants in the control group received conventional oral ibuprofen, taken as needed for pain relief. The primary outcome was the change in the Visual Analog Scale score. Secondary outcomes included the COX Menstrual Symptom Scale, Traditional Chinese Medicine pattern score, sleep index, and psychological assessments. All outcomes were evaluated at three time points: baseline, after the first treatment cycle, and after the second treatment cycle. All participants underwent two fMRI sessions-both resting-state and task-state fMRI scans-during days 1-3 of their menstrual cycle: once before enrollment and once after the treatment period. All statistical analyses followed the intention-to-treat principle. Discussion: This study aims to provide high-level clinical evidence on pain relief, symptom improvement, and brain functional network regulation for the treatment of cold congestion stasis type dysmenorrhea with Tuina therapy, using a randomized controlled trial design combined with functional magnetic resonance imaging. Clinical Trial Registration: https://itmctr.ccebtcm.org.cn, International Traditional Medicine Clinical Trial Registry ITMCTR2026001387.