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Completed

NCT Number: NCT04075357

Amniotic Membrane in Carpal Tunnel Syndrome

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Oftalmología

Mexico City, 06800, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amniotic membrane transplantation

Other

Amniotic membrane was located over median nerve during surgery of CTS, prior of closing.

Primary outcomes

  1. BCTQ

    Time frame: Through study completion, an average one year

    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.

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Collaborators

  • National Council of Science and Technology, Mexico

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 30, 2019
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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