Amniotic Membrane in Carpal Tunnel Syndrome
Amniotic Membrane Transplantation for Carpal Tunnel Syndrome Treatment: One-year Follow-up
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2019
CompletedFirst Submitted
Initial submission to the registry
August 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2019
CompletedFirst Posted
Study publicly available on registry
August 30, 2019
CompletedAugust 30, 2019
August 1, 2019
1.5 years
August 28, 2019
August 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Control
NO INTERVENTIONThe patients underwent conventional CTS surgery
Experimental
EXPERIMENTALThe patients underwent conventional CTS surgery and transplantation of amniotic membrane
Interventions
Amniotic membrane was located over median nerve during surgery of CTS, prior of closing.
Eligibility Criteria
You may qualify if:
- Patients with recent CTS diagnosis
- Patients that undergo CTS surgery
- Patients that accept to participate in the study
- Patients that sign informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Oftalmología
Mexico City, 06800, Mexico
Related Publications (1)
Buentello-Volante B, Molina-Medinilla M, Aguayo-Flores E, Magana-Guerrero FS, Garfias Y. Comparison of amniotic membrane transplantation and carpal tunnel syndrome release surgery (CTRS) and CTRS alone: Clinical outcomes at 1-year follow-up. J Tissue Eng Regen Med. 2020 May;14(5):714-722. doi: 10.1002/term.3033. Epub 2020 Mar 24.
PMID: 32174033DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2019
First Posted
August 30, 2019
Study Start
February 1, 2018
Primary Completion
July 21, 2019
Study Completion
August 28, 2019
Last Updated
August 30, 2019
Record last verified: 2019-08