Amniotic Membrane in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Amniotic Membrane Transplantation for Carpal Tunnel Syndrome Treatment: One-year Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04075357
• Other study ID #: CEI-2016/10/04
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: August 28, 2019

Study information

• Verified date: August 2019
• Source: Instituto de Oftalmología Fundación Conde de Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 28, 2019
• Est. primary completion date: July 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Other:
• Amniotic membrane transplantation
Amniotic membrane was located over median nerve during surgery of CTS, prior of closing.

Locations

Country	Name	City	State
Mexico	Instituto de Oftalmología	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana	National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCTQ	The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific measure of self-reported symptom severity and functional status. It is frequently used in the reporting of outcomes from trials into interventions for carpal tunnel syndrome.; It has two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and uses a five-point rating scale and the Functional Status Scale (FSS) containing 8 items which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.	Through study completion, an average one year