Comparison of Leech Therapy with Medical Treatment on Clinical Symptoms and Nerve-Muscle Changes in Patients with Moderate Carpal Tunnel Syndrome: A Protocol Study

Background: This study aimed to compare the severity of clinical symptoms and nerve-muscle alterations in patients with moderate carpal tunnel syndrome (CTS) between leech therapy and medical treatment. Methods: This study is a randomized clinical trial protocol. The research population consists of patients with moderate CTS, as determined by clinical symptoms and electrodiagnostic tests (EMG-NCV). A total of 60 patients will be selected through convenience sampling and randomly assigned to two groups: 1) control group (medical treatment) and 2) intervention group (medical treatment and leech therapy). Data were collected using a personal information questionnaire, a visual analog scale (VAS) for pain assessment, and the Boston Carpal Tunnel Questionnaire. The questionnaires were completed by patients at four time points: baseline, day 15, day 30, and day 60. The severity of clinical symptoms and NCV-EMG test results at baseline were compared with those at day 60. Data were analyzed using SPSS version 16 software, with statistical tests including mean, standard deviation, frequency, repeated measures ANOVA, Bonferroni, and Mann-Whitney U tests. The Clinical Trials.gov identifier for the trial is IRCT20180909040977N1. The trial was registered on January 8, 2019. Discussion: The findings of this clinical trial may demonstrate the effectiveness of leech therapy as a complementary treatment for CTS and its potential to prevent complications associated with conventional medical treatment.