Carpal tunnel syndrome (CTS) is the most common focal entrapment mononeuropathy, 
comprising medium nerve chronic inflammation and fibrosis. Although carpal 
tunnel release surgery (CTRS) has demonstrated to be effective, around 3% to 25% 
of CTRS show recurrence. Amniotic membrane transplantation (AMT) has been used 
in different pathologies inhibiting inflammation and fibrosis and promoting 
nerve repair. The aim of this study was to determine the efficacy of AMT in 
CTRS. The present study comprised a randomized, single-blind controlled trial to 
compare the 1-year follow-up outcomes of AMT in CTRS (AMT group) or CTRS alone 
(control group) in patients with CTS. Thirty-five patients with unilateral or 
bilateral CTS were enrolled, and 47 wrists were randomized into two groups: the 
AMT group and the control group. To compare the outcomes, three different 
questionnaires scores (Boston Carpal Tunnel Syndrome Questionnaire, Disabilities 
of the Arm, Shoulder, and Hand, and Historical-Objective scale) were used. 
Evaluations were assessed at baseline and at 15 days, 1, 3, 6, and 12 months 
after surgery. Compared with the control group, the AMT group showed significant 
(p < 0.05) reductions in all scores from 6 months after surgery until the end of 
the study. Both AMT and control groups showed significant intragroup differences 
in all scores, since the first month after surgery until the end of the study in 
comparison with the baseline scores. Taken together, these results indicate that 
CTRS in conjunction with AMT is more effective than CTRS alone in patients with 
CTS at 1-year follow-up. Clinical Trial: NCT04075357; Amniotic Membrane in 
Carpal Tunnel Syndrome.