Clinical Trial

Effectiveness of Amniotic Membrane Combined With Secretome as an Adjunct to Carpal Tunnel Release Surgery: Evaluation Using the Boston Carpal Tunnel Questionnaire and Electromyography

Study acronym: Secretome CTS
Recruiting Early Phase 1
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Summary
Carpal Tunnel Syndrome (CTS) is a compressive neuropathy caused by chronic compression of the median nerve within the carpal tunnel, resulting in pain, numbness, tingling, and impaired hand function. This study is a randomized controlled trial with a pre- and post-intervention experimental design to evaluate the effectiveness of adjunctive amniotic membrane combined with secretome in patients with moderate-to-severe CTS undergoing carpal tunnel release surgery. Participants will be randomly assigned to receive either standard surgical treatment alone or surgery with the addition of amniotic membrane and secretome. Clinical and electrophysiological outcomes will be evaluated before surgery and at 3 weeks after the intervention using the Boston Carpal Tunnel Questionnaire (BCTQ) and electromyography (EMG) to assess symptom improvement, functional recovery, and median nerve regeneration.
Trial Details
NCT Number NCT07723313
Lead Sponsor PT. Prodia Stem Cell Indonesia
Collaborators: RSUP Prof. Dr. I.G.N.G. Ngoerahal
Conditions Carpal Tunnel Syndrome (CTS)
Enrollment 30 participants
Start Date 2025-12-15
Primary Completion 2026-03-15 (estimated)
Study Completion 2026-08-15 (estimated)
Updated on ClinicalTrials.gov 2026-07-23