Carpal Tunnel SyndromePhase 2ECHOCARPENCT02514317
Percutaneous Treatment of Carpal Tunnel Syndrome With Scan
A Phase 2 study testing percutaneous treatment and Ultrasound in people with Carpal Tunnel Syndrome, run by University Hospital, Caen at 1 site in France.
Trial summary
The objective of the study is to evaluate in patients suffering from carpal tunnel syndrome resistant to medical treatment, clinical course after percutaneous treatment under ultrasound guidance. 40 patients will be included in the study. 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?
- percutaneous treatment and Ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Apr 2013
- Phase
- Phase 2
- 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 older than 18 years who signed the informed consent.
- Patient with an Carpal Tunnel Syndrome
Who cannot join
- patient has already undergone surgery of Carpal Tunnel Syndrome
- Patient with contra-indications to anesthesia (heart failure, kidney, liver).
- Pregnant women
- alcoholics in weaning period
- Patient whose consent is altered or unable to get a safety procedure
- Patient with contra-indication to lidocaine
- Patient with contra-indication for the realization of ultrasound endoscopy (carpal tunnel syndrome secondary or anastomosis between the median and ulnar nerves: anastomosis Berritini)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-assisted Percutaneous Release of Carpal Tunnel Syndrome
The objective of the study is to evaluate in patients suffering from carpal tunnel syndrome resistant to medical treatment, clinical course after percutaneous treatment under ultrasound guidance. 40 patients will be included in the study. The following parameters will be evaluated: patient satisfaction, pain, functional disability, quality of life and time to return to work. The medico-economic aspect will be analyzed.
Read the detailed description
Ultrasound analysis of Carpal tunnel is used for many years, especially for diagnostic purposes. Investigators have shown, first by a study of 104 cadavers that it was possible to reduce the opening by making the gesture under ultrasound guidance and to perform the procedure under local anesthesia. Then investigators performed an open study of 25 patients confirming the absence of iatrogenic lesions with this new technique.
The percutaneous treatment of carpal tunnel syndrome under ultrasound guidance is a gesture of interventional radiology. One can envisage making this type of treatment in interventional radiology room which overcomes the operating room and thus reduce costs.
The objective of the study is to continue the study of percutaneous treatment of carpal tunnel syndrome under ultrasound guidance by an open study conducted in interventional radiology room.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- percutaneous treatment, Ultrasound
- 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.
percutaneous treatmentProcedure or surgery
UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| percutaneous treatment | Experimental | percutaneous treatment of carpal tunnel syndrome under ultrasound guidance in interventional radiology room. Receives: Procedure: percutaneous treatment; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (visual analogic scale)
visual analogic scale
Measured: change between baseline and day 90 after surgery
paresthesia
Measured: change between baseline and day 90 after surgery
muscle strength (dynamometer JAMARD)
dynamometer JAMARD
Measured: change between baseline and day 90 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionApr 2013
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.
- More trials run by University Hospital, CaenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514317
- Sponsor's protocol ID
- 11-058
- Acronym
- ECHOCARPE
- Status last verified
- Jul 2015
- First submitted
- 23 Jul 2015
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lecoq B, Hanouz N, Morello R, Jean-Jacques PY, Dutheil JJ, Hulet C, Marcelli C. Ultrasound-assisted surgical release of carpal tunnel syndrome: Results of a pilot open-label uncontrolled trial conducted outside the operating theatre. Joint Bone Spine. 2015 Dec;82(6):442-5. doi: 10.1016/j.jbspin.2015.01.024. Epub 2015 Apr 13.
PubMed 25881757
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-assisted Percutaneous Release of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT02514317
- Acronym / sponsor ID
- ECHOCARPE / 11-058
- Conditions
- Carpal Tunnel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Aug 2015 (estimated)
- 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.
The objective of the study is to evaluate in patients suffering from carpal tunnel syndrome resistant to medical treatment, clinical course after percutaneous treatment under ultrasound guidance. 40 patients will be included in the study. The following parameters will be evaluated: patient satisfaction, pain, functional disability, quality of life and time to return to work. The medico-economic aspect will be analyzed.
Detailed description
Ultrasound analysis of Carpal tunnel is used for many years, especially for diagnostic purposes. Investigators have shown, first by a study of 104 cadavers that it was possible to reduce the opening by making the gesture under ultrasound guidance and to perform the procedure under local anesthesia. Then investigators performed an open study of 25 patients confirming the absence of iatrogenic lesions with this new technique.
The percutaneous treatment of carpal tunnel syndrome under ultrasound guidance is a gesture of interventional radiology. One can envisage making this type of treatment in interventional radiology room which overcomes the operating room and thus reduce costs.
The objective of the study is to continue the study of percutaneous treatment of carpal tunnel syndrome under ultrasound guidance by an open study conducted in interventional radiology room.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| percutaneous treatment | Experimental | Procedure: percutaneous treatment, Device: Ultrasoundpercutaneous treatment of carpal tunnel syndrome under ultrasound guidance in interventional radiology room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient older than 18 years who signed the informed consent.
- Patient with an Carpal Tunnel Syndrome
Key exclusion criteria (7 listed)
- patient has already undergone surgery of Carpal Tunnel Syndrome
- Patient with contra-indications to anesthesia (heart failure, kidney, liver).
- Pregnant women
- alcoholics in weaning period
- Patient whose consent is altered or unable to get a safety procedure
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 |
|---|---|---|
| percutaneous treatment | Procedure or surgery | percutaneous treatment |
| Ultrasound | Device | percutaneous treatment |
Primary outcome
Pain (visual analogic scale)
Time frame: change between baseline and day 90 after surgery
visual analogic scale
paresthesia
Time frame: change between baseline and day 90 after surgery
muscle strength (dynamometer JAMARD)
Time frame: change between baseline and day 90 after surgery
dynamometer JAMARD
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 3 Apr 2026.
- Results publication: PubMed 25881757Lecoq B, Hanouz N, Morello R, Jean-Jacques PY, Dutheil JJ, Hulet C, Marcelli C. Ultrasound-assisted surgical release of carpal tunnel syndrome: Results of a pilot open-label uncontrolled trial conducted outside the operating theatre. Joint Bone Spine. 2015 Dec;82(6):442-5. doi: 10.1016/j.jbspin.2015.01.024. Epub 2015 Apr 13.
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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 Phase 2 study testing percutaneous treatment and Ultrasound in people with Carpal Tunnel Syndrome, run by University Hospital, Caen 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 2 inclusion and 7 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 3 Apr 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain (visual analogic scale) (time frame: change between baseline and day 90 after surgery). The study lists 3 primary outcomes in all. 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 NCT02514317, 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 3 Apr 2026.