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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

RecruitingEARLY Phase 1Ages 18 Years - anyAllPT. Prodia Stem Cell Indonesia
NCT07723313 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
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What it tests

  • Secretome
  • amniotic membrane
  • Standard surgery
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Where

1 site
Prof. dr. I.G.N.G. Ngoerah General Hospital
Denpasar, Indonesia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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