Clinical trial NCT04075357: Amniotic Membrane in Carpal Tunnel Syndrome
Official title: Amniotic Membrane Transplantation for Carpal Tunnel Syndrome Treatment: One-year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Amniotic membrane transplantation
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
Collaborators: name: National Council of Science and Technology, Mexico
First posted: 2019-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carpal Tunnel Syndrome (CTS) is the most frequent mononeuropathy. CTS is more frequent in females than in males, it has been associated to work activities, hormone exposure and obesity. Although its primary treatment is conservative, there is strong evidence that patients who retard surgery are more prone to develop worse outcomes. Surgery to treat CTS consists in liberating carpal tunnel in order to ameliorate median nerve symptoms; however, more than 20% of patients who undergo surgery have recurrent CTS (RCTS). RCTS is due to a fibrotic process in the site of the surgery. Amniotic membrane (AM) is the inner layer of the placenta which has been used to treat different pathologies. AM transplantation (AMT) has demonstrated to significantly inhibit inflammation and fibrosis. Therefore, the aim of the present study was to determine the effect of AMT in CTS surgery. The present is a randomized, open labeled, controlled clinical study. The investigators included patients with recent diagnosis of CTS and divided into two groups. The experimental group received AMT concomitantly with conventional surgery; whilst, the control group received only the conventional surgery. Clinical status of patients measured with the BCTQ questionaire was the main outcome. Both groups showed similar BCTQ punctuation at the beginning of the study. However, the results of the experimental group were significantly better than those from the control group through time, until the finish of the study. None of the patients presented complications or adverse effects related to the AMT. These results indicate that AMT is a secure and suitable treatment for CTS presenting better clinical outcomes at one-year follow-up.


Eligibility criteria: Inclusion Criteria:

* Patients with recent CTS diagnosis
* Patients that undergo CTS surgery
* Patients that accept to participate in the study
* Patients that sign informed consent

Exclusion Criteria:

* Patients with recurrent CTS diagnosis;
* Patients with concomitant hand/arm comorbidities
* Patients with any systemic disease that comprises muscles and bones
* Collagenopathies
* Systemic lupus erythematosus

Primary outcomes:
measure: BCTQ
timeFrame: Through study completion, an average one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto de Oftalmología
Study officials:
References:
citation: Buentello-Volante B, Molina-Medinilla M, Aguayo-Flores E, Magana-Guerrero FS, Garfias Y. Comparison of amniotic membrane transplantation and carpal tunnel syndrome release surgery (CTRS) and CTRS alone: Clinical outcomes at 1-year follow-up. J Tissue Eng Regen Med. 2020 May;14(5):714-722. doi: 10.1002/term.3033. Epub 2020 Mar 24.