Ultrasound-Guided vs Non-Guided Pharmacopuncture for Cervical Myofascial Pain Syndrome: A Multi-Center Prospective Comparative Study Protocol

Kwangho Kim,1 Juhwan Song,1 Hongmin Chu,1,2 Robin Kwon,1,3 Seongjun Park,1,4 Junhui Kwon,1,5 Hyeon Joon Hong,1,6 Youngyun Lee,1,7 Sanghyuk Kwon,1,3 Kyungho Kang,1,8 Jungtae Leem,9,10 Cheol-Hyun Kim1,11 1The Academy of Korean Medicine Clinical Anatomy, Seoul, Korea; 2Mapo Hongik Korean Medicine Clinic, Seoul, Korea; 3Department of Korean Medicine, Jinjeop Hanyang Hospital, Namyangju, Korea; 4Mullae Majubom Korean Medicine Clinic, Seoul, Korea; 5Anjung Korean Medicine Clinic, Seoul, Korea; 6Gwanghwamun Kyung Hee Korean Medicine Clinic, Seoul, Korea; 7Kangnyung Korean Medicine Clinic, Anyang, Korea; 8Yangjae Chungwoo Korean Medicine Clinic, Seoul, Korea; 9Research Center of Traditional Korean Medicine, College of Korean Medicine, Wonkwang University, Iksan, Korea; 10Department of Diagnostics, College of Korean Medicine, Wonkwang University, Iksan, Korea; 11Department of Internal Medicine, College of Korean Medicine, Wonkwang University, Iksan, KoreaCorrespondence: Jungtae Leem, Department of Diagnostics, College of Korean Medicine, Wonkwang University, Iksan, Korea, Tel +82-63-850-6984, Fax +82-63-850-6985, Email [email protected] Cheol-Hyun Kim, Department of Internal Medicine, College of Korean Medicine, Wonkwang University, Iksan, Korea, Tel +82-62-670-6412, Fax +82-62-670-6492, Email [email protected]: Cervical Myofascial Pain Syndrome (CMPS) is a common musculoskeletal disorder that significantly impacts daily life due to pain and restricted movement. This study focuses on Ultrasound-Guided Pharmacopuncture(UGP) to release fascial restrictions and alleviate nerve compression. By utilizing real-time ultrasound imaging, UGP is expected to enhance treatment accuracy, reduce adverse events, and improve clinical outcomes. This study aims to assess the efficacy and safety of UGP compared to Non-Guided Pharmacopuncture (NGP) in patients with acute CMPS.Patients and Methods: This multi-center prospective observational comparative study evaluates the efficacy and safety of UGP versus NGP in patients with acute CMPS. A minimum of 100 patients with acute CMPS (≤ 7 days since symptom onset) will be recruited from two hospitals and five Korean medicine clinics. Participants will be randomly assigned to either the UGP group (receiving ultrasound-guided pharmacopuncture with Hominis Placenta(HP) solution) or the NGP group (receiving non-guided pharmacopuncture with HP solution). A single treatment session will be conducted, with pre- and post-treatment assessments using the Numerical Rating Scale (NRS), Pressure Pain Threshold (PPT), and Range of Motion (ROM). Additionally, a follow-up safety assessment will be conducted via telephone 24– 36 hours post-treatment.Discussion and Conclusion: This study is the first to evaluate the efficacy and safety of ultrasound-guided HP pharmacopuncture for acute CMPS in a multi-center prospective comparative study. The findings are expected to provide comprehensive evidence supporting ultrasound-guided pharmacopuncture as an effective treatment for myofascial pain and may expand its clinical applications, particularly in Korean medicine clinics.Keywords: ultrasonography, acupuncture therapy, pharmacopuncture, myofascial pain syndrome, needle guidance technique