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

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.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome (CTS)
• Intervention / Treatment: Biological: Secretome; Other: amniotic membrane; Procedure: Standard surgery

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia, 80113
      • Recruiting
      • Prof. dr. I.G.N.G. Ngoerah General Hospital
      • Contact: Shianita Limena, Medical Doctor; Phone Number: +62 811-910-624; Email: shianita.limena@gmail.com
      • Principal Investigator: Made Bramantya Karna, Medical Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Amnion Membrane + Secretome	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 Names: UC-MSCs-derived Secretome; Mesenchymal Stem Cells-derived Secretome
Active Comparator: Amniotic Membrane	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.
Placebo Comparator: Standard Surgery	Procedure: Standard surgery; Participants will undergo standard carpal tunnel release surgery without the addition of amniotic membrane or secretome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Carpal Tunnel Questionnaire (BCTQ) score	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.	Baseline and 3 weeks postoperatively
Electromyography (EMG)	Electromyography (EMG) will be performed to assess changes in median nerve electrophysiological function, including nerve conduction parameters, from baseline to 3 weeks after surgery.	Baseline and 3 weeks postoperatively

Collaborators and Investigators

• Sponsor: PT. Prodia Stem Cell Indonesia
• Collaborators: RS Prof. Dr. I.G.N.G Ngoerah

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Actual): March 15, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome; Equipment and Supplies; Metabolism; Bandages; Metabolome; Biological Dressings; Secretome
• Other Study ID Numbers: CT/CTS/01/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because participant consent for public data sharing was not obtained, and institutional policies require that individual-level clinical data remain confidential.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No