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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

NCT07723313 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-23

No results posted yet for this study

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.

Conditions

  • Carpal Tunnel Syndrome (CTS)

Interventions

BIOLOGICAL

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.

OTHER

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.

PROCEDURE

Standard surgery

Participants will undergo standard carpal tunnel release surgery without the addition of amniotic membrane or secretome.

Sponsors & Collaborators

  • RSUP Prof. Dr. I.G.N.G. Ngoerahal

    collaborator OTHER

  • PT. Prodia Stem Cell Indonesia

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2026-03-15
Completion
2026-08-15

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07723313 on ClinicalTrials.gov