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

Recruiting now · Early Phase 1

Conditions studied: Carpal Tunnel Syndrome (CTS)

In brief

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 facts

Study ID

NCT07723313

Run by

PT. Prodia Stem Cell Indonesia

People needed

30

Starts

2025-12-15

Expected to finish

2026-08-15

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18 years or older.
• Diagnosed with moderate-to-severe Carpal Tunnel Syndrome (CTS) based on electromyography (EMG) according to the Bland classification.
• Persistent CTS symptoms that have not improved with conservative treatment.
• Willing and able to provide written informed consent and comply with study procedures.

You may not qualify if…

• Previous carpal tunnel release surgery on the affected wrist.
• History of wrist trauma or previous wrist surgery.
• Presence of comorbidities that may affect nerve healing or study outcomes, including diabetes mellitus, hypertension, or metabolic disorders.
• Symptoms resembling CTS are attributable to other conditions, such as cervical spine or cervical nerve disorders (e.g., cervical radiculopathy).

Where it is running

• Prof. dr. I.G.N.G. Ngoerah General Hospital — Denpasar, Bali, Indonesia (enrolling)

Full record on ClinicalTrials.gov

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