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Effectiveness of Amniotic Membrane Combined With Secretome as an Adjunct to Carpal Tunnel Release Surgery: Evaluation Using the Boston Carpal Tunnel Questionnaire and Electromyography
Sponsor: PT. Prodia Stem Cell Indonesia
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-12-15
Completion Date
2026-08-15
Last Updated
2026-07-23
Healthy Volunteers
No
Conditions
Interventions
Secretome
Participants undergoing carpal tunnel release surgery will receive a 10 mm × 10 mm amniotic membrane soaked in 1.5 mL of secretome solution for 1 minute before application to the median nerve at the surgical site.
amniotic membrane
Participants undergoing carpal tunnel release surgery will receive a 10 mm × 10 mm amniotic membrane applied to the median nerve at the surgical site without secretome.
Standard surgery
Participants will undergo standard carpal tunnel release surgery without the addition of amniotic membrane or secretome.
Locations (1)
Prof. dr. I.G.N.G. Ngoerah General Hospital
Denpasar, Bali, Indonesia