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Amniotic Membrane in Carpal Tunnel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04075357
Recruitment Status : Completed
First Posted : August 30, 2019
Last Update Posted : August 30, 2019
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Instituto de Oftalmología Fundación Conde de Valenciana

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Other: Amniotic membrane transplantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Amniotic Membrane Transplantation for Carpal Tunnel Syndrome Treatment: One-year Follow-up
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : July 21, 2019
Actual Study Completion Date : August 28, 2019

Arm Intervention/treatment
No Intervention: Control
The patients underwent conventional CTS surgery
Experimental: Experimental
The patients underwent conventional CTS surgery and transplantation of amniotic membrane
Other: Amniotic membrane transplantation
Amniotic membrane was located over median nerve during surgery of CTS, prior of closing.

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04075357

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Instituto de Oftalmología
Mexico City, Mexico, 06800
Sponsors and Collaborators
Instituto de Oftalmología Fundación Conde de Valenciana
National Council of Science and Technology, Mexico
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Instituto de Oftalmología Fundación Conde de Valenciana Identifier: NCT04075357    
Other Study ID Numbers: CEI-2016/10/04
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual participant data will be published in a Journal. Therefore it will be supplied elsewhere.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Oftalmología Fundación Conde de Valenciana:
Amniotic membrane transplantation
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Pathologic Processes
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries