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

Early Phase 1RecruitingNCT07723313

PT. Prodia Stem Cell Indonesia30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Carpal Tunnel Syndrome (CTS)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: 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.