Acupotomy for Cervical Spondylosis-Related Neck Pain: A Study Protocol for a Randomized Controlled Trial

Cervical spondylosis (CS) is a common source of neck pain and imposes a substantial global health burden. Conservative treatments, including oral medication, physical therapy, and rehabilitation exercises, are widely used in clinical practice, but their effects are often limited or slow to become apparent. Acupotomy, a minimally invasive intervention that combines acupuncture principles with soft-tissue release techniques, may alleviate CS-related neck pain by releasing local adhesions and reducing muscle tension. However, methodologically rigorous evidence from randomized controlled trials regarding its efficacy and safety remains limited.

This study is a prospective, assessor- and statistician-blinded, randomized parallel-group trial involving patients with CS-related neck pain. The primary hypothesis is that an ultrasound-guided acupotomy-based treatment strategy is more effective than standard medication in reducing pain intensity in patients with CS-related neck pain. Eligible participants will be randomly assigned in a 1:1 ratio to either an acupotomy group or a control group. To strengthen methodological rigor and minimize potential assessment bias, the trial incorporates assessor and statistician blinding, standardized ultrasound guidance during the acupotomy procedure to improve precision and safety, and a predefined sample size calculated based on statistical power analysis. The intervention consists of a 3-week treatment period, followed by a 12-week follow-up period after completion of treatment. The primary outcome will be pain intensity assessed using the Visual Analog Scale (VAS). Secondary outcomes will include the Neck Disability Index (NDI), cervical range of motion (ROM), and health-related quality of life as measured by the 36-item Short Form Health Survey (SF-36). The primary efficacy analysis will be performed using the full analysis set, defined as a modified intention-to-treat population.

This trial is designed to evaluate the comparative effectiveness and safety of an ultrasound-guided acupotomy-based treatment strategy compared with celecoxib for CS-related neck pain. The findings of this study are expected to provide clinically relevant information regarding the feasibility, safety, and potential clinical value of this treatment strategy.

International Traditional Medicine Clinical Trial Registry (ITMCTR2026000837). Registered on 31 March 2026. The protocol was approved by the Ethics Committee of the First Affiliated Hospital of Shandong First Medical University on 11 March 2026 (YXLL-KY-2026(062)).