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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 — Early Phase 1, Recruiting, 30 participants, PT. Prodia Stem Cell Indonesia
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RegistryNCT07723313, acronym Secretome CTS
StatusRecruiting
PhaseEarly Phase 1
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment30 (Estimated)
SponsorPT. Prodia Stem Cell Indonesia (Industry); collaborators: RSUP Prof. Dr. I.G.N.G. Ngoerahal
ConditionsCarpal Tunnel Syndrome (CTS)
InterventionsSecretome, amniotic membrane, Standard surgery (Biological, other, procedure)
Datesstart 2025-12-15, primary completion 2026-03-15, completion 2026-08-15 (estimated), first posted 2026-07-23, last updated 2026-07-23
Locations1 site in Indonesia

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Amnion Membrane + SecretomeActive comparatorBiological: Secretome
Amniotic MembraneActive comparatorOther: amniotic membrane
Standard SurgeryPlacebo comparatorProcedure: Standard surgery
  • Secretome (Biological), also known as UC-MSCs-derived Secretome, Mesenchymal Stem Cells-derived 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 (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.

+Outcome measures

Primary outcomes

  • Boston Carpal Tunnel Questionnaire (BCTQ) score [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.
  • Electromyography (EMG) [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.

+Eligibility

Sex: All, ages: 18 Years to any

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).

+Locations (1)

FacilityCityCountryStatus
Prof. dr. I.G.N.G. Ngoerah General HospitalDenpasar, BaliIndonesiaRecruiting

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