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 | Recruiting Early Phase 1 DMC

• 1 other identifier: CT/CTS/01/2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome (CTS)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Amnion Membrane + Secretome

ACTIVE COMPARATOR

Biological: Secretome

Amniotic Membrane

ACTIVE COMPARATOR

Other: amniotic membrane

Standard Surgery

PLACEBO COMPARATOR

Procedure: Standard surgery

Interventions

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.

Also known as: UC-MSCs-derived Secretome, Mesenchymal Stem Cells-derived Secretome

Amnion Membrane + 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.

Amniotic Membrane

Standard surgery PROCEDURE

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

Standard Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• PT. Prodia Stem Cell Indonesia: lead
• RS Prof. Dr. I.G.N.G Ngoerah: collaborator

Study Sites (1)

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

Denpasar, Bali, 80113, Indonesia

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Secretome; Biological Dressings

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Metabolome; Metabolism; Bandages; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: December 15, 2025
• Primary Completion: March 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)