Effectiveness and Safety of Ultrasound-Guided Pharmacopuncture for Carpal Tunnel Syndrome: Protocol for A Multicenter, Randomized, Assessor-Blinded, Waiting-List-Controlled Clinical Trial.

INTRODUCTION: Carpal tunnel syndrome (CTS) is a common compressive neuropathy caused by entrapment of the median nerve within the carpal tunnel. Although conventional treatments such as injections and surgery are used, Korean medicine interventions, including pharmacopuncture, are also used in clinical practice. However, clinical evidence from randomized controlled trials of pharmacopuncture for CTS remains limited. Ultrasound-guided pharmacopuncture may improve procedural precision by enabling real-time identification of the median nerve and surrounding anatomical structures.

OBJECTIVE: To evaluate the effectiveness and safety of a pragmatic ultrasound-guided pharmacopuncture as an additional treatment to lifestyle management and exercise education in patients with carpal tunnel syndrome.

METHODS AND ANALYSIS: This is a multicenter, randomized, assessor-blinded, waiting-list-controlled clinical trial registered with the Clinical Research Information Service (CRIS; KCT0011180). A total of 64 participants with clinically diagnosed CTS will be enrolled at two Korean medicine hospitals and randomly allocated in a 1:1 ratio to either the intervention group or the waiting-list control group. The intervention group will receive ultrasound-guided pharmacopuncture once weekly for 3 weeks in addition to lifestyle management and exercise education, whereas the waiting-list control group will receive lifestyle management and exercise education only during the study period. The primary outcome is the change in hand numbness and pain visual analog scale score from baseline to Visit 4 (Week 4). Secondary outcomes include the Boston Carpal Tunnel Questionnaire, median nerve cross-sectional area measured by ultrasound, maximum grip strength of the affected hand, and Patient Global Impression of Change. The primary effectiveness outcome will be evaluated in the full analysis set using a mixed-effects model for repeated measures.

CONCLUSION: This trial will provide comparative effectiveness and safety evidence for ultrasound-guided pharmacopuncture added to lifestyle management and exercise education in patients with carpal tunnel syndrome.