Amniotic Membrane in Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Amniotic membrane transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Amniotic membrane transplantation
Eligibility Criteria
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
Sites / Locations
- Instituto de Oftalmología
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Experimental
Arm Description
The patients underwent conventional CTS surgery
The patients underwent conventional CTS surgery and transplantation of amniotic membrane
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04075357
First Posted
August 28, 2019
Last Updated
August 29, 2019
Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
Collaborators
National Council of Science and Technology, Mexico
1. Study Identification
Unique Protocol Identification Number
NCT04075357
Brief Title
Amniotic Membrane in Carpal Tunnel Syndrome
Official Title
Amniotic Membrane Transplantation for Carpal Tunnel Syndrome Treatment: One-year Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
July 21, 2019 (Actual)
Study Completion Date
August 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
Collaborators
National Council of Science and Technology, Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Amniotic membrane transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
The patients underwent conventional CTS surgery
Arm Title
Experimental
Arm Type
Experimental
Arm Description
The patients underwent conventional CTS surgery and transplantation of amniotic membrane
Intervention Type
Other
Intervention Name(s)
Amniotic membrane transplantation
Intervention Description
Amniotic membrane was located over median nerve during surgery of CTS, prior of closing.
Primary Outcome Measure Information:
Title
BCTQ
Description
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.
Time Frame
Through study completion, an average one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Instituto de Oftalmología
City
Mexico City
ZIP/Postal Code
06800
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Individual participant data will be published in a Journal. Therefore it will be supplied elsewhere.
Citations:
PubMed Identifier
32174033
Citation
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.
Results Reference
derived
Learn more about this trial
Amniotic Membrane in Carpal Tunnel Syndrome
We'll reach out to this number within 24 hrs