Amniotic Membrane in Carpal Tunnel Syndrome

Instituto de Oftalmología Fundación Conde de Valenciana

Status: Completed

Conditions: Carpal Tunnel Syndrome

Treatments: Other: Amniotic membrane transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04075357

CEI-2016/10/04

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control

No Intervention group

Description:

The patients underwent conventional CTS surgery

Experimental

Experimental group

Description:

The patients underwent conventional CTS surgery and transplantation of amniotic membrane

Treatment:

Other: Amniotic membrane transplantation