NCT04075357

Amniotic Membrane in Carpal Tunnel Syndrome

Completed NA Last updated 30 August 2019

What this trial tests

NA trial testing Amniotic membrane transplantation in Carpal Tunnel Syndrome in 60 participants. Completed in 28 August 2019.

Timeline

1 February 2018

Primary endpoint
21 July 2019

28 August 2019

Quick facts

Lead sponsor	Instituto de Oftalmología Fundación Conde de Valenciana
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 February 2018
Primary completion	21 July 2019
Estimated completion	28 August 2019
Sites	1 location across Mexico

Drugs / interventions tested

• Amniotic membrane transplantation

Conditions studied

• Carpal Tunnel Syndrome — all drugs for Carpal Tunnel Syndrome →

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana — full company profile →

Who can join

Adults 18 to 65, any sex, with Carpal Tunnel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of amniotic membrane transplantation and carpal tunnel syndrome release surgery (CTRS) and CTRS alone: Clinical outcomes at 1-year follow-up.
   Buentello-Volante B, Molina-Medinilla M, Aguayo-Flores E, Magaña-Guerrero FS, et al · · 2020 · cited 9× · PMID 32174033 · DOI 10.1002/term.3033