Carpal Tunnel SyndromeCATSNCT04117516
Safety and Efficacy of Percutaneous Carpal Tunnel Release Versus Open Surgery
A study testing Open surgery and Percutaneous surgery in people with Carpal Tunnel Syndrome, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
Trial summary
Hypothesis: Percutaneous ambulatory carpal tunnel release offers similar outcomes to the open approach in the theatre. Study design: Two-groups randomized single-blind interventional non-inferiority clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Open surgery and Percutaneous surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jun 2019to 30 Nov 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old.
- Positive electromyography, confirming carpal tunnel syndrome.
- Capable to understand risks and advantages of both procedures.
- Normal blood tests.
Who cannot join
- Previous carpal tunnel release in the same hand.
- Previous fracture or dislocation in the area around the forearm, wrist or hand.
- Signs or symptoms of infection.
- Psychiatric disorders.
- Antiplatelet or anticoagulant therapy, that cannot be suspended due to underlying pathology, and does not allow the surgery to be performed.
- Coagulation disorders, or any underlying pathology, with high risk of thrombosis or bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Percutaneous Carpal Tunnel Release Versus Open Surgery: a Randomized Clinical Trial.
Hypothesis: Percutaneous ambulatory carpal tunnel release offers similar outcomes to the open approach in the theatre.
Study design: Two-groups randomized single-blind interventional non-inferiority clinical trial.
Read the detailed description
Background: Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the upper limb, with a prevalence of around 1'14% and 14'4% of the population.
The clinical symptoms are usually pain, paresthesias and numbness on the sensitive distribution territory of the median nerve in the hand.
Conservative treatment is used for the mild cases, and surgery for the moderate and severe ones, or when the conservative treatment has failed.
Open carpal tunnel release is the gold standard surgery, with a short longitudinal volar approach that allows to visualize the complete division of the ligament.
Over the last few years, endoscopic techniques have been introduced, offering some advantages such as: lower postoperative pain, earlier return to work and less complications due to the wound. Despite this, it has not been popularised, probably, because it is a challenging and more expensive surgical procedure.
Based on the minimally invasive endoscopic approach, and with the aim of obtaining the same benefits, and avoid the complications of the open surgery, several devices have been developed to perform a percutaneous release.
Hypothesis: Percutaneous ambulatory carpal tunnel release offers similar outcomes to the open approach in the theatre.
Study design: Two-groups randomized single-blind interventional non-inferiority clinical trial.
Methods: Sixty patients reporting CTS symptoms, that are confirmed by clinical exam and nerve conduction studies, will be included. Participants will be randomized in two arms. Patients from one group will be operated with an open carpal tunnel release, in the theatre, with tourniquet, under local anesthesia and sedation, through a short longitudinal volar "classical" approach of the hand, that allows to visualize the complete division of the ligament. The other group will be operated with a percutaneous approach, ambulatory, with a short transverse volar approach, 1-2cm proximal to the wrist, under Wide Awake Local Anesthesia with No Tourniquet.
The main outcome measures will be the Boston Carpal Tunnel Questionnaire, Quick DASH questionnaire, Douleur Neuropathique 4 questions, Visual Numeric Scale and grip strength. The scales and questionnaires will be administrated to participants preoperative, 4 weeks and 24 weeks postoperative.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Open surgery, Percutaneous surgery
- Keywords
- Percutaneous carpal tunnel release
- 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.
Open surgeryProcedure or surgery
Open carpal tunnel release will be performed, in the theatre, with tourniquet, under local anesthesia and sedation, through a short longitudinal volar "classical" approach of the hand, that allows to visualize the complete division of the ligament.
Percutaneous surgeryProcedure or surgery
Percutaneous carpal tunnel release will be performed, ambulatory, with a percutaneous scalpel, through a short transverse volar approach, 1-2cm proximal to the wrist, under Wide Awake Local Anesthesia with No Tourniquet.
| Study group | Role | What they receive |
|---|---|---|
| Open surgery | Active comparator | 30 patients will be operated with an open carpal tunnel release. Receives: Procedure: Open surgery |
| Percutaneous surgery | Experimental | 30 patients will be operated with a percutaneous carpal tunnel release. Receives: Procedure: Percutaneous surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Boston Carpal Tunnel Questionnaire
Outcomes from both interventions will be measured with this symptom severity and functional status carpal tunnel specific scale.
The range of the final results are from 19 (no symptoms) to 95 (severe symptoms).
Measured: Preoperative, 4 weeks and 24 weeks after surgery.
Secondary outcomes (7)
Visual Numeric Scale
Pain relief will be measured with the VNS. The range of the scale is from 0 (no symptoms) to 10 (severe symptoms).
Measured: Preoperative, 4 weeks and 24 weeks after surgery.
Quick-DASH (Disabilities of Arm, Shoulder and Hand)
Disabilities of the hand will be measured with Quick-DASH. The range of the final results are from 0 (no symptoms) to 100 (severe symptoms).
Measured: Preoperative, 4 weeks and 24 weeks after surgery.
Douleur Neuropathique 4 questions (DN4)
Neuropathic pain relief with the DN4. The range of the final results are from 0 (no symptoms) to 10 (severe symptoms).
A result of more than 4 indicates neuropathic pain.
Measured: Preoperative, 4 weeks and 24 weeks after surgery.
Consumer Reports Effectiveness Scale (CRES-4)
Patient´s satisfaction after the procedures The range of the final results are from 0 to 300. A higher score indicates a better outcome of the treatment for the patient.
Measured: 24 weeks after surgery.
Time off work
Differences in time off work between both procedures measured in days.
Measured: 24 weeks after surgery.
Grip strength
Measured in Kilograms with a "Deyard EH101" dynamometer
Measured: Preoperative, 4 weeks and 24 weeks after surgery.
Number of other complications
Any complication will be recorded.
Measured: 4 weeks and 24 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start5 Jun 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Coloma, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117516
- Sponsor's protocol ID
- COTHAV1
- Acronym
- CATS
- Status last verified
- Mar 2022
- First submitted
- 11 Aug 2019
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Percutaneous Carpal Tunnel Release Versus Open Surgery: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04117516
- Acronym / sponsor ID
- CATS / COTHAV1
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Percutaneous carpal tunnel release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 7 Oct 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.
Hypothesis: Percutaneous ambulatory carpal tunnel release offers similar outcomes to the open approach in the theatre.
Study design: Two-groups randomized single-blind interventional non-inferiority clinical trial.
Detailed description
Background: Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the upper limb, with a prevalence of around 1'14% and 14'4% of the population.
The clinical symptoms are usually pain, paresthesias and numbness on the sensitive distribution territory of the median nerve in the hand.
Conservative treatment is used for the mild cases, and surgery for the moderate and severe ones, or when the conservative treatment has failed.
Open carpal tunnel release is the gold standard surgery, with a short longitudinal volar approach that allows to visualize the complete division of the ligament.
Over the last few years, endoscopic techniques have been introduced, offering some advantages such as: lower postoperative pain, earlier return to work and less complications due to the wound. Despite this, it has not been popularised, probably, because it is a challenging and more expensive surgical procedure.
Based on the minimally invasive endoscopic approach, and with the aim of obtaining the same benefits, and avoid the complications of the open surgery, several devices have been developed to perform a percutaneous release.
Hypothesis: Percutaneous ambulatory carpal tunnel release offers similar outcomes to the open approach in the theatre.
Study design: Two-groups randomized single-blind interventional non-inferiority clinical trial.
Methods: Sixty patients reporting CTS symptoms, that are confirmed by clinical exam and nerve conduction studies, will be included. Participants will be randomized in two arms. Patients from one group will be operated with an open carpal tunnel release, in the theatre, with tourniquet, under local anesthesia and sedation, through a short longitudinal volar "classical" approach of the hand, that allows to visualize the complete division of the ligament. The other group will be operated with a percutaneous approach, ambulatory, with a short transverse volar approach, 1-2cm proximal to the wrist, under Wide Awake Local Anesthesia with No Tourniquet.
The main outcome measures will be the Boston Carpal Tunnel Questionnaire, Quick DASH questionnaire, Douleur Neuropathique 4 questions, Visual Numeric Scale and grip strength. The scales and questionnaires will be administrated to participants preoperative, 4 weeks and 24 weeks postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open surgery | Active comparator | Procedure: Open surgery30 patients will be operated with an open carpal tunnel release. |
| Percutaneous surgery | Experimental | Procedure: Percutaneous surgery30 patients will be operated with a percutaneous carpal tunnel release. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old.
- Positive electromyography, confirming carpal tunnel syndrome.
- Capable to understand risks and advantages of both procedures.
- Normal blood tests.
Key exclusion criteria (6 listed)
- Previous carpal tunnel release in the same hand.
- Previous fracture or dislocation in the area around the forearm, wrist or hand.
- Signs or symptoms of infection.
- Psychiatric disorders.
- Antiplatelet or anticoagulant therapy, that cannot be suspended due to underlying pathology, and does not allow the surgery to be performed.
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 |
|---|---|---|
| Open surgeryOpen carpal tunnel release will be performed, in the theatre, with tourniquet, under local anesthesia and sedation, through a short longitudinal volar "classical" approach of the hand, that allows to visualize the complete division of the ligament. | Procedure or surgery | Open surgery |
| Percutaneous surgeryPercutaneous carpal tunnel release will be performed, ambulatory, with a percutaneous scalpel, through a short transverse volar approach, 1-2cm proximal to the wrist, under Wide Awake Local Anesthesia with No Tourniquet. | Procedure or surgery | Percutaneous surgery |
Primary outcome
Change in Boston Carpal Tunnel Questionnaire
Time frame: Preoperative, 4 weeks and 24 weeks after surgery.
Outcomes from both interventions will be measured with this symptom severity and functional status carpal tunnel specific scale. The range of the final results are from 19 (no symptoms) to 95 (severe symptoms).
7 secondary outcomes
Visual Numeric Scale
Time frame: Preoperative, 4 weeks and 24 weeks after surgery.
Quick-DASH (Disabilities of Arm, Shoulder and Hand)
Time frame: Preoperative, 4 weeks and 24 weeks after surgery.
Douleur Neuropathique 4 questions (DN4)
Time frame: Preoperative, 4 weeks and 24 weeks after surgery.
Consumer Reports Effectiveness Scale (CRES-4)
Time frame: 24 weeks after surgery.
Time off work
Time frame: 24 weeks after surgery.
Grip strength
Time frame: Preoperative, 4 weeks and 24 weeks after surgery.
Number of other complications
Time frame: 4 weeks and 24 weeks after surgery.
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 22 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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 Open surgery and Percutaneous surgery in people with Carpal Tunnel Syndrome, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
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 6 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 22 Mar 2022. 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 Spain. 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?
Change in Boston Carpal Tunnel Questionnaire (time frame: Preoperative, 4 weeks and 24 weeks after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2022.