Effectiveness of Amniotic Membrane Combined With Secretome as an Adjunct to Carpal Tunnel Release Surgery: Evaluation Using the Boston Carpal Tunnel Questionnaire and Electromyography
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Secretome, amniotic membrane, Standard surgery.
- Who it may be relevant to
- Registry conditions: Carpal Tunnel Syndrome (CTS). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- 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 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. - Procedure Standard surgery
Participants will undergo standard carpal tunnel release surgery without the addition of amniotic membrane or secretome.
Primary outcome measures
- Boston Carpal Tunnel Questionnaire (BCTQ) score [Time frame: Baseline and 3 weeks postoperatively]
- Electromyography (EMG) [Time frame: Baseline and 3 weeks postoperatively]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Indonesia · 1 center
- Prof. dr. I.G.N.G. Ngoerah General Hospital — Denpasar
Identifiers
NCT: NCT07723313 · CT/CTS/01/2026