Mononeuritis Multiplex Clinical Trials

Find Mononeuritis Multiplex Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other, Biological
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Indonesia
Prof. dr. I.G.N.G. Ngoerah General Hospital
RECRUITING
Denpasar
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2026-08-15
Participants
Target number of participants: 30
Treatments
Active_comparator: Amnion Membrane + Secretome
Active_comparator: Amniotic Membrane
Placebo_comparator: Standard Surgery
Sponsors
Leads: PT. Prodia Stem Cell Indonesia
Collaborators: RSUP Prof. Dr. I.G.N.G. Ngoerahal

This content was sourced from clinicaltrials.gov