Carpal Tunnel SyndromeNCT04075357
Amniotic Membrane in Carpal Tunnel Syndrome
A study testing Amniotic membrane transplantation in people with Carpal Tunnel Syndrome, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Amniotic membrane transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 1 Feb 2018to 28 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with recent CTS diagnosis
- Patients that undergo CTS surgery
- Patients that accept to participate in the study
- Patients that sign informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Amniotic Membrane Transplantation for Carpal Tunnel Syndrome Treatment: One-year Follow-up
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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Amniotic membrane transplantation
- Keywords
- Amniotic membrane transplantation
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic membrane transplantationOther
Amniotic membrane was located over median nerve during surgery of CTS, prior of closing.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The patients underwent conventional CTS surgery |
| Experimental | Experimental | The patients underwent conventional CTS surgery and transplantation of amniotic membrane Receives: Other: Amniotic membrane transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start1 Feb 2018
- Primary completion21 Jul 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075357
- Sponsor's protocol ID
- CEI-2016/10/04
- Status last verified
- Aug 2019
- First submitted
- 28 Aug 2019
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will be published in a Journal. Therefore it will be supplied elsewhere.
Publications
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.
PubMed 32174033
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amniotic Membrane Transplantation for Carpal Tunnel Syndrome Treatment: One-year Follow-up
- ClinicalTrials.gov ID
- NCT04075357
- Acronym / sponsor ID
- CEI-2016/10/04
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Amniotic membrane transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 21 Jul 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The patients underwent conventional CTS surgery |
| Experimental | Experimental | Other: Amniotic membrane transplantationThe patients underwent conventional CTS surgery and transplantation of amniotic membrane |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with recent CTS diagnosis
- Patients that undergo CTS surgery
- Patients that accept to participate in the study
- Patients that sign informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amniotic membrane transplantationAmniotic membrane was located over median nerve during surgery of CTS, prior of closing. | Other | Experimental |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Derived from this study: PubMed 32174033Buentello-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.
- Individual participant dataSharing planned: Undecided. Individual participant data will be published in a Journal. Therefore it will be supplied elsewhere.
Related trials for Carpal Tunnel Syndrome
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
Not yet recruitingObservational study
Symptom Recovery Time After the Phalen Test in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS)
Not yet recruiting
Effectiveness of Sensorimotor Proprioceptive Stimulation Combined With Conventional Physical Therapy on Symptoms, Sensory Function, Proprioception, and Hand Function in Patients With Mild-to-Moderate Carpal Tunnel Syndrome
Carpel Tunnel Syndrome
Recruiting
Effect of Night-time and Full-time Splinting for Carpal Tunnel Syndrome
Carpal Tunnel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amniotic membrane transplantation in people with Carpal Tunnel Syndrome, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCTQ (time frame: Through study completion, an average one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04075357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.