Amniotic Membrane in Carpal Tunnel Syndrome
|ClinicalTrials.gov Identifier: NCT04075357|
Recruitment Status : Completed
First Posted : August 30, 2019
Last Update Posted : August 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Carpal Tunnel Syndrome||Other: Amniotic membrane transplantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
No Intervention: Control
The patients underwent conventional CTS surgery
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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT04075357
|Instituto de Oftalmología|
|Mexico City, Mexico, 06800|