Effectiveness of Nerve Block Alone, Nerve Block with Acupotomy, Nerve Block with Acupotomy and Pharmacopuncture in Patients with Cervical Radiculopathy: A Protocol for a Three-Arm Randomized Controlled Trial

Objectives This study aimed to compare the effectiveness and safety of acupotomy with or without pharmacopuncture combined with epidural steroid injection for patients with cervical radiculopathy in a pragmatic clinical setting.Methods This three-arm, evaluator-blinded, randomized pilot trial will enroll 39 patients with cervical radiculopathy, allocating them in a 1:1:1 ratio.All participants will receive epidural steroid injections.Experimental group A will additionally receive acupotomy and pharmacopuncture, while experimental group B will receive only acupotomy.The primary outcome is the change in the Neck Disability Index (NDI) at week 4. Secondary outcomes include NDI changes at weeks 2 and 8, the Numeral Rating Scale (NRS) for cervical and upper extremity pain, the Northwick Park Neck Pain Questionnaire (NPQ), the European Quality of Life 5 Dimension (EQ-5D), and the incidence of adverse events.Results The mean changes in the primary and secondary outcomes will be calculated and compared among the three treatment groups.Safety outcomes, including the incidence of adverse events, will also be analyzed.Conclusions This pragmatic pilot randomized controlled trial will provide preliminary results on the comparative effectiveness and safety of adding acupotomy, with or without pharmacopuncture, to epidural steroid injections.The findings are expected to inform treatment selection and guide the design of a larger, multi-center, full-scale study..