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NCT Number: NCT07723313

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

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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Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Prof. dr. I.G.N.G. Ngoerah General Hospital

Denpasar, Bali, 80113, Indonesia

Location status: Recruiting

Location contact

Made Bramantya Karna, Medical Doctor

PRINCIPAL_INVESTIGATOR

Shianita Limena, Medical Doctor

CONTACT

[email protected]

+62 811-910-624

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Secretome

Biological

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 names: UC-MSCs-derived Secretome, Mesenchymal Stem Cells-derived Secretome

amniotic membrane

Other

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

Procedure

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

Primary outcomes

  1. Boston Carpal Tunnel Questionnaire (BCTQ) score

    Time frame: Baseline and 3 weeks postoperatively

    The Boston Carpal Tunnel Questionnaire (BCTQ), consisting of the Symptom Severity Scale (SSS) and Functional Status Scale (FSS), will be used to evaluate changes in symptom severity and hand function from baseline to 3 weeks after surgery.

  2. Electromyography (EMG)

    Time frame: Baseline and 3 weeks postoperatively

    Electromyography (EMG) will be performed to assess changes in median nerve electrophysiological function, including nerve conduction parameters, from baseline to 3 weeks after surgery.

Sponsors and collaborators

Lead sponsor

PT. Prodia Stem Cell Indonesia

Industry

Collaborators

  • RS Prof. Dr. I.G.N.G Ngoerah

Registry information

Acronym: Secretome CTS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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