Study Protocol for a Randomized Pragmatic Clinical Trial Evaluating Pharmacopuncture Versus Acupuncture for Chronic Neck Pain

Background: Neck pain is a common musculoskeletal disorder, which is becoming increasingly common with the rise in computer and smartphone use. For many, this condition leads to chronic discomfort, and disability in daily life. Although pharmacopuncture represents a major treatment modality for neck pain in Korean medicine, its effectiveness and safety as compared with standard acupuncture has not been thoroughly investigated.Methods: A study protocol for a multicenter, pragmatic, randomized clinical trial was designed with a parallel-group approach. A total of 128 participants, each experiencing chronic neck pain for at least 3 months, will be recruited. Participants will be randomly assigned to either the pharmacopuncture or acupuncture group and receive treatment twice weekly for 4 weeks. The primary outcome will be the change in score for neck pain, as assessed using the numeric rating scale, 5 weeks after baseline. Secondary outcomes will include evaluations using the visual analog scale, Northwick Park Questionnaire, Neck Disability Index, Patient Global Impression of Change, Health-Related Quality of Life Instrument with eight items, and the EuroQol-5 Dimension. In addition, a cost-effectiveness analysis will be conducted and reported separately.Discussion: The rigorous study design is intended to ultimately provide practical evidence for clinicians and policymakers regarding the use of pharmacopuncture treatment for chronic neck pain. By directly comparing its effectiveness with standard acupuncture, the results of the trial outcomes will offer insights that may inform future healthcare decisions. Trial registration: This protocol has been registered at ClinicalTrials.gov (NCT06520462) on July 25, 2024.