Efficacy of Spinal Tuinan combined with Microneedle knife in the treatment of neurogenic cervical spondylosis: study protocol for a randomized controlled trial

Background: Neurogenic cervical spondylosis(NCS) is the most common type of cervical spondylosis, accounting for approximately 60 percent. Our research team has accumulated rich clinical experience in the treatment of cervical spondylosis and has carried out research related to manipulation and acupuncture therapies. This project further develops scientific research on neurogenic cervical spondylosis based on previous studies. A randomized controlled study was conducted on spinal tuina, microneedle knife, and spinal tuina combined with microneedle knife. We will observe the changes in clinical symptoms and imaging findings in patients with neurogenic cervical spondylosis by the three treatments, and evaluate the clinical efficacy and adverse reactions of the three treatments. There is great significance in guiding the clinical treatment of neurogenic cervical spondylosis. Methods: This is a single-site, single-blind, randomized, controlled trial. A total of 90 participants will be randomly allocated to the Spinal Tuina group (Group A), Microneedle knife group (Group B) or Spinal Tuina combined with Microneedle knife group (Group C) in a 1:1:1 ratio. Patients will receive three acupuncture treatment sessions per week for 2 consecutive weeks. All patients will then receive a 4-week follow-up. Primary outcome is the effective rate. The secondary outcomes are the amount of improvement in trapezius muscle tone, the Neck Disability Index score, the Visual Analogue Score(VAS), and the cervical curvature values. Adverse events will be monitored in the treatment period and follow-up period. Discussion: This trial may provide high-quality evidence for the efficacy and safety of Spinal Tuinan combined with Microneedle knife for NCS. The results of this study will be published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry ChiCTR2200061381. Registered on 7 June 2022.