Carpal Tunnel Syndrome (CTS)EPECNCT07668310
Effectiveness of PErcutaneous Ultrasound-guided Carpal Tunnel Release: a Non-inferiority Study With Surgery as Comparator
A study testing Carpal tunnel surgery and Questionnaires in people with Carpal Tunnel Syndrome (CTS), run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Carpal tunnel syndrome is a common condition caused by compression of the median nerve. Tingling in the first three or four fingers, usually at night or upon waking, is the most frequent symptom. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Carpal tunnel surgery and Questionnaires
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 15 Mar 2025
- 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
- Patient, male or female, over 18 years of age
- Patient with clinical carpal tunnel syndrome
- Patient with unilateral or bilateral carpal tunnel syndrome. In the case of bilateral involvement, the more symptomatic hand (with the highest Boston score) will be included, with the patient agreeing that the second hand will not be operated on within one year.
- Patient with carpal tunnel syndrome confirmed by an EMG less than 6 months old
- Patient with carpal tunnel syndrome without motor or sensory deficits
- Patient with carpal tunnel syndrome resistant to conservative treatment, including at least one corticosteroid injection
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- Patient agreeing to undergo surgery
- Patient affiliated with or covered by a social security plan
- Patient who has been informed and has signed a free and informed written consent.
Who cannot join
- Patient with another condition of the hand or wrist (Dupuytren's disease, inflammatory rheumatism, symptomatic osteoarthritis)
- Patient with a history of previous hand or wrist surgery requiring treatment
- Neurological sequelae of the hand
- Patient with non-medicinal hypocoagulation or vitamin K antagonist overdose
- Patient with a known allergy to lidocaine
- Patient with an unhealed palmo-digital wound
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- Patient with a superficial or deep palmo-digital infection or inflammation
- Patient who has received a cortisone injection in the hand or wrist within the last month. - Patient with type 1 diabetes or poorly controlled diabetes (HbA1c >7.5% for less than 3 months)
- Patient with cognitive impairment deemed incompatible with the research by the investigator
- Patient with a language barrier preventing a reliable assessment
- Patient participating in another clinical trial
- Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant, breastfeeding, or postpartum woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of PErcutaneous Ultrasound-guided Carpal Tunnel Release: a Non-inferiority Study With Surgery as Comparator (Projet)
Carpal tunnel syndrome is a common condition caused by compression of the median nerve. Tingling in the first three or four fingers, usually at night or upon waking, is the most frequent symptom. Reduced sensation in the fingers and clumsiness can also occur, and in severe cases, there may even be weakness in thumb abduction with thenar muscle wasting. Carpal tunnel syndrome (CTS) is the most commonly diagnosed nerve compression syndrome. The annual incidence of diagnosis varies depending on the study and the country. It's estimated at 3.8 per thousand in the general population, 1 to 2 per thousand in men, 4 to 5 per thousand in women, with a peak between ages 40 and 60.
Medical treatment combines removing a microtraumatic factor, immobilization with a brace, and giving 1 to 2 cortisone injections into the carpal tunnel. The results are good in purely sensory cases. If it doesn't work, things get worse despite treatment, or in severe cases from the start (severe sensory problems, loss of strength, muscle wasting), surgery is recommended.
Read more
Several teams have recently demonstrated the benefits of using a minimally invasive ultrasound-guided surgical technique to perform flexor retinaculum sectioning under ultrasound guidance. This technique offers increased safety thanks to continuous ultrasound monitoring and the visualization of median nerve variants. Rojo et al. compared ultrasound surgery with a 1 mm incision to mini-open surgery with a 20 mm incision in 128 patients. This study suggests that a minimally invasive approach could allow for faster functional pain recovery compared to conventional surgery.
This project is based on the hypothesis that the proposed ultrasound-guided percutaneous release technique has an efficacy and tolerability profile suitable for widespread use in the indication of carpal tunnel syndrome resistant to conservative treatment, and that it can therefore reduce the need for conventional surgery in this indication.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Carpal tunnel surgery, Questionnaires
- 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.
Carpal tunnel surgeryProcedure or surgery
The aim of this study is to compare the conventional surgery to the percutaneous ultrasound-guided carpal tunnel release procedure. One group is doing the conventional surgery and the other the procédure to evaluate.
QuestionnairesOther
EVA, Boston and Quick Dash questionnaires : all study visits
| Study group | Role | What they receive |
|---|---|---|
| Patient undergoing percutaneous ultrasound-guided carpal tunnel release procedure. | Experimental | Not described Receives: Procedure: Carpal tunnel surgery; Other: Questionnaires |
| Patient undergoing conventional surgery. | Active comparator | Not described Receives: Procedure: Carpal tunnel surgery; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of symptoms" subscore of the Boston Questionnaire
The "Severity of symptoms" subscore of the Boston Questionnaire, specific to carpal tunnel syndrome, 3 months post-intervention, assessed by the clinical research associate, blinded to the procedure performed.
Eleven questions with a score between 1 and 5 for each items. The final score is between 11 (no symptoms) and 55 (very high severity).
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jan 2023
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Why it stopped: Investigator's illness and recrutement difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668310
- Sponsor's protocol ID
- 2020-A00191-38
- Acronym
- EPEC
- Status last verified
- Jul 2026
- First submitted
- 19 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of PErcutaneous Ultrasound-guided Carpal Tunnel Release: a Non-inferiority Study With Surgery as Comparator (Projet)
- ClinicalTrials.gov ID
- NCT07668310
- Acronym / sponsor ID
- EPEC / 2020-A00191-38
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator's illness and recrutement difficulties
- Enrolment
- 7 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 25 Jun 2026 (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 is a common condition caused by compression of the median nerve. Tingling in the first three or four fingers, usually at night or upon waking, is the most frequent symptom. Reduced sensation in the fingers and clumsiness can also occur, and in severe cases, there may even be weakness in thumb abduction with thenar muscle wasting. Carpal tunnel syndrome (CTS) is the most commonly diagnosed nerve compression syndrome. The annual incidence of diagnosis varies depending on the study and the country. It's estimated at 3.8 per thousand in the general population, 1 to 2 per thousand in men, 4 to 5 per thousand in women, with a peak between ages 40 and 60.
Medical treatment combines removing a microtraumatic factor, immobilization with a brace, and giving 1 to 2 cortisone injections into the carpal tunnel. The results are good in purely sensory cases. If it doesn't work, things get worse despite treatment, or in severe cases from the start (severe sensory problems, loss of strength, muscle wasting), surgery is recommended.
Several teams have recently demonstrated the benefits of using a minimally invasive ultrasound-guided surgical technique to perform flexor retinaculum sectioning under ultrasound guidance. This technique offers increased safety thanks to continuous ultrasound monitoring and the visualization of median nerve variants. Rojo et al. compared ultrasound surgery with a 1 mm incision to mini-open surgery with a 20 mm incision in 128 patients. This study suggests that a minimally invasive approach could allow for faster functional pain recovery compared to conventional surgery.
This project is based on the hypothesis that the proposed ultrasound-guided percutaneous release technique has an efficacy and tolerability profile suitable for widespread use in the indication of carpal tunnel syndrome resistant to conservative treatment, and that it can therefore reduce the need for conventional surgery in this indication.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient undergoing percutaneous ultrasound-guided carpal tunnel release procedure. | Experimental | Procedure: Carpal tunnel surgery, Other: Questionnaires |
| Patient undergoing conventional surgery. | Active comparator | Procedure: Carpal tunnel surgery, Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient, male or female, over 18 years of age
- Patient with clinical carpal tunnel syndrome
- Patient with unilateral or bilateral carpal tunnel syndrome. In the case of bilateral involvement, the more symptomatic hand (with the highest Boston score) will be included, with the patient agreeing that the second hand will not be operated on within one year.
- Patient with carpal tunnel syndrome confirmed by an EMG less than 6 months old
- Patient with carpal tunnel syndrome without motor or sensory deficits
Key exclusion criteria (13 listed)
- Patient with another condition of the hand or wrist (Dupuytren's disease, inflammatory rheumatism, symptomatic osteoarthritis)
- Patient with a history of previous hand or wrist surgery requiring treatment
- Neurological sequelae of the hand
- Patient with non-medicinal hypocoagulation or vitamin K antagonist overdose
- Patient with a known allergy to lidocaine
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 |
|---|---|---|
| Carpal tunnel surgeryThe aim of this study is to compare the conventional surgery to the percutaneous ultrasound-guided carpal tunnel release procedure. One group is doing the conventional surgery and the other the procédure to evaluate. | Procedure or surgery | Patient undergoing conventional surgery., Patient undergoing percutaneous ultrasound-guided carpal tunnel release procedure. |
| QuestionnairesEVA, Boston and Quick Dash questionnaires : all study visits | Other | Patient undergoing conventional surgery., Patient undergoing percutaneous ultrasound-guided carpal tunnel release procedure. |
Primary outcome
Severity of symptoms" subscore of the Boston Questionnaire
Time frame: 3 months after surgery
The "Severity of symptoms" subscore of the Boston Questionnaire, specific to carpal tunnel syndrome, 3 months post-intervention, assessed by the clinical research associate, blinded to the procedure performed. Eleven questions with a score between 1 and 5 for each items. The final score is between 11 (no symptoms) and 55 (very high severity).
Results and safety
The study was stopped early (reason given: Investigator's illness and recrutement difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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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 Carpal tunnel surgery and Questionnaires in people with Carpal Tunnel Syndrome (CTS), run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 9 inclusion and 13 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: stopped early, as of the sponsor's last update on 16 Jul 2026. 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 France. 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 was stopped early (reason given: Investigator's illness and recrutement difficulties). Results are not available in the source record.
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?
Severity of symptoms" subscore of the Boston Questionnaire (time frame: 3 months 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 16 Jul 2026.