The Clinical Efficacy and Multimodal Imaging Mechanism of the Knot-tying Technique in the Treatment of Chronic Neck Pain

This study is a multicenter 1:1 randomized controlled trial, enrolling patients with chronic neck pain from the Rehabilitation Medicine Department of Huizhou Third People's Hospital. A total of 60 participants are planned to be recruited, divided 1:1 into a trial group receiving the knot-release acupuncture method and a sham acupuncture control group. The study aims to evaluate the immediate clinical efficacy and safety of the knot-release acupuncture method for treating chronic neck pain and to explore its peripheral-to-central mechanisms using multimodal detection technologies. The research content includes: 1. Dynamically monitoring core evaluation indicators in enrolled patients, including VAS scores, real-time shear wave elastography (SWE), cervical range of motion (ROM), Neck Disability Index (NDI-TH), and functional near-infrared spectroscopy (fNIRS), to assess the immediate clinical efficacy and safety of the knot-release acupuncture method for chronic neck pain. 2. Observing and recording any adverse events throughout the intervention period, systematically and scientifically evaluating the clinical safety of the knot-release acupuncture method for chronic neck pain, and providing a safety basis for its standardized clinical application.

Inclusion Criteria: * Meet the diagnostic criteria for chronic neck pain; * Aged 20-65, any gender; * Experienced neck pain in the past 7 days and complain of neck pain and limited range of motion; ④ Diagnosed with chronic neck pain at their medical institution or another healthcare facility; ⑤ Have at least one active myofascial trigger point (MTrP) in the unilateral trapezius area; ⑥ Voluntarily choose to participate in this study and sign the informed consent form; ⑦ Visual analog scale (VAS) score ≥3 at rest; Exclusion Criteria: * Took medication or received treatment for neck or shoulder muscle pain or discomfort in the past 7 days; * Have a history of neck surgery in the past 3 months; * Suffered a neck sprain from trauma such as a traffic accident or contusion in the past 3 months; * Have cervical radiculopathy, cervical disc herniation, spinal canal stenosis, fracture, dislocation, infection, tuberculosis, tumor, rheumatic autoimmune disease, spinal cord lesions, or severe neurological deficits; * Have acute soft tissue injury, related rheumatic diseases, congenital cervical deformities, psychogenic pain, or suspected/confirmed vertebral or spinal canal tumors, tuberculosis, or severe osteoporosis; ⑥ Have severe heart (or has a pacemaker), liver, kidney, cerebrovascular, tumor diseases, or other conditions the researchers consider unsuitable for participation; ⑦ (Females only) Have been pregnant or given birth in the past 6 months; ⑧ Participated in other clinical intervention studies in the past 3 months; ⑨ Other individuals deemed unsuitable for the study by medical staff, such as those with impaired cognitive function who cannot understand the consent form or provide voluntary consent.