Evaluating Amniotic Membrane and Secretome Added to Surgery for Moderate-to-Severe Carpal Tunnel Syndrome Using Symptom Questionnaires and Nerve Tests

What this Trial Is About

Carpal Tunnel Syndrome CTS is caused by pressure on the median nerve in the wrist, leading to pain, numbness, tingling, and reduced hand function. This trial examines how adding amniotic membrane combined with secretome to standard carpal tunnel release surgery affects symptom relief and nerve recovery in adults with moderate-to-severe CTS. The study is a randomized controlled trial comparing surgery alone to surgery plus these biological treatments, using clinical and nerve tests to evaluate results. Participants will be randomly assigned to one of three groups standard carpal tunnel release surgery, surgery with amniotic membrane applied to the median nerve, or surgery with amniotic membrane soaked in secretome solution applied to the nerve. The amniotic membrane used measures 10 mm by 10 mm and is applied during surgery. Secretome is soaked onto the membrane for one minute before placement. The study focuses on treatments delivered during the surgical procedure. Participants will be assessed before surgery and again three weeks after the procedure. Evaluations include the Boston Carpal Tunnel Questionnaire BCTQ to measure symptoms and hand function, and electromyography EMG to assess nerve regeneration. The study is double-blinded and sponsored by PT. Prodia Stem Cell Indonesia. Participants are expected to comply with study procedures and provide informed consent, with total follow-up lasting at least three weeks post-surgery.

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