Acupuncture at Sensitized Acupoints versus Sham Acupuncture for Neck-Type Cervical Spondylosis: Study Protocol for a Randomized Controlled Trial

针对颈椎病敏感穴位的针灸治疗与假针灸治疗的比较:一项随机对照试验的研究方案

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Abstract

PURPOSE: Neck-type cervical spondylosis (NTCS) is the most common subtype of cervical spondylosis. Acupuncture is frequently employed in the clinical management of NTCS. According to the traditional Chinese medicine theory of acupoint sensitization, acupoints represent both highly sensitive reactive sites during pathological states and the principal loci for therapeutic stimulation via acupuncture. Stimulating strongly sensitive points has been shown to be effective in treating disease and may enhance clinical efficacy. This study aims to investigate the clinical effect and safety of acupuncture at sensitized acupoints (SA) in alleviating symptoms in patients with NTCS, based on the specificity of acupoint sensitization. PATIENTS AND METHODS: This is a single-center, prospective, patient- and assessor-blinded, randomized, sham-controlled trial involving patients diagnosed with NTCS. Participants will be randomly assigned in a 1:1 ratio to two groups: the SA group and sham acupuncture (SHA) group. All participants will be treated with acupuncture three times during the first week, followed by a subsequent assessment scheduled in week five. The primary outcome is the alteration in the intensity of neck pain, assessed with the visual analogue scale. Secondary outcomes include changes in the neck disability index, range of motion, the 12-item short form health survey, cervical musculoskeletal ultrasound findings, and pressure pain threshold values. The intention-to-treat analysis will be applied for statistics. CONCLUSION: This trial will be the first randomized controlled trial to investigate the therapeutic efficacy and safety profile of acupuncture SA in the treatment of NTCS. It is also the first trial to combine subjective and objective outcome measures to comprehensively evaluate acupuncture's curative effect on NTCS management. The findings may provide evidence supporting acupuncture as an effective treatment option for NTCS and offer insights into its underlying biological mechanisms. TRIAL REGISTRATION: ClinicalTrials.gov (https://clinicaltrials.gov/), identifier: NCT06847945.

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