Carpal Tunnel Syndrome (CTS)ESTERELNCT07375134
Observational Study - Heel Syndrome and Relationship to Flexor Retinacular Ligament Thickness
An observational study of Carpal Tunnel Syndrome (CTS) and Heel Pain Syndrome, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Numerous studies have examined the relationship between carpal tunnel syndrome and the thickness of the flexor retinacular ligament. This varies along the course of the median nerve (the distal portion being the thickest) and increases with age. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS), Heel Pain Syndrome
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2024to 1 Jun 2026
- Phase
- Observational
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients operated on for carpal tunnel syndrome by the same operator using the Chow technique.
Who may be able to join
- Male or female patient over 18 years of age
- Patient who has been informed of the research and has not indicated their opposition to the use of their medical data
- Patient who is a candidate for first-time carpal tunnel surgery
Who cannot join
- Emergency surgery performed in a post-traumatic context
- Mental impairment or any other reason that may hinder understanding or strict application of the protocol
- Patient not affiliated with the French social security system
- Patient under legal protection, guardianship, or curatorship
- Patient already included in another therapeutic study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Relationship Between Flexor Retinacular Ligament Thickness and the Development of Heel Pain Syndrome After Carpal Tunnel Surgery.
Numerous studies have examined the relationship between carpal tunnel syndrome and the thickness of the flexor retinacular ligament. This varies along the course of the median nerve (the distal portion being the thickest) and increases with age. These studies have shown that the thickness of the ligament is greater in patients with carpal tunnel syndrome, without, however, demonstrating that it is related to the onset of this syndrome. According to Bartolomé-Villar, it may rather influence the onset of carpal pain.
The objective of this study is to determine whether a relationship exists between the thickness of the flexor retinacular ligament and the development of heel syndrome in the postoperative period for carpal tunnel syndrome.
Read the detailed description
This is a prospective, longitudinal, single-center, open-label observational study conducted on a population of patients operated on for carpal tunnel syndrome.
This study does not alter patient care or the doctor-patient relationship. Evaluations take place during routinely scheduled consultations. The frequency of evaluations is consistent with standard postoperative follow-up.
- Conditions
- Carpal Tunnel Syndrome (CTS), Heel Pain Syndrome
- Keywords
- heel pain syndrome, patients operated on for carpal tunnel syndrome, thickness of the flexor retinacular ligament
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with heel-of-hand syndrome 6 months after surgery for carpal tunnel syndrome | Patients with heel of the hand syndrome, 6 months after surgery for carpal tunnel syndrome (measurement of retinacular ligament thickness intraoperatively) | |
| Patients without heel of the hand syndrome 6 months after surgery for carpal tunnel syndrome | Patients without heel of the hand syndrome, 6 months after surgery for carpal tunnel syndrome (measurement of retinacular ligament thickness intraoperatively) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the intraoperative measurement of flexor retinacular ligament thickness between the two groups of patients operated on for carpal tunnel syndrome by the same surgeon using the Chow technique (with and without hand heel syndrome).
Intraoperative measurement of flexor retinacular ligament thickness
Measured: perioperatively
Secondary outcomes (3)
Assess the existence of other factors that may be related to the occurrence of hand heel syndrome (Spontaneous pain) according to the initial characteristics and follow-up data of patients with and without hand heel syndrome.
Spontaneous pain in the heel of the hand assessed by the patient on a simple numeric rating scale (SNS) from 0 to 10 (0 = no pain, 10 = maximum pain).
Measured: Baseline to six months after the surgery
Assess the existence of other factors that may be linked to the occurrence of heel hand syndrome (Pain on palpation of the heel of the hand) based on initial characteristics and follow-up data, patients with and without hand heel syndrome
Pain on palpation of the heel of the hand assessed by the patient on a simple numeric rating scale (SNS) from 0 to 10 (0 = no pain, 10 = maximum pain).
Measured: Baseline to six months after the surgery
Assess the existence of other factors that may be linked to the occurrence of heel hand syndrome (Postoperative complications) based on follow-up data, patients with and without hand heel syndrome
Postoperative complications (inflammatory scar or keloid, complex regional pain syndrome, infection or hematoma).
Measured: Immediately after the intervention to six months postoperatory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start22 Oct 2024
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio DINH, Dr, Principal investigator, Hôpital Privé Paul d'Egine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375134
- Sponsor's protocol ID
- COS-RGDS-2023-12-034-P-DINH-A
- Acronym
- ESTEREL
- Status last verified
- Jun 2026
- First submitted
- 25 Nov 2025
- Last updated
- 5 Jun 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Flexor Retinacular Ligament Thickness and the Development of Heel Pain Syndrome After Carpal Tunnel Surgery.
- ClinicalTrials.gov ID
- NCT07375134
- Acronym / sponsor ID
- ESTEREL / COS-RGDS-2023-12-034-P-DINH-A
- Conditions
- Carpal Tunnel Syndrome (CTS), Heel Pain Syndrome
- Keywords
- heel pain syndrome, patients operated on for carpal tunnel syndrome, thickness of the flexor retinacular ligament
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 29 Jan 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.
Numerous studies have examined the relationship between carpal tunnel syndrome and the thickness of the flexor retinacular ligament. This varies along the course of the median nerve (the distal portion being the thickest) and increases with age. These studies have shown that the thickness of the ligament is greater in patients with carpal tunnel syndrome, without, however, demonstrating that it is related to the onset of this syndrome. According to Bartolomé-Villar, it may rather influence the onset of carpal pain.
The objective of this study is to determine whether a relationship exists between the thickness of the flexor retinacular ligament and the development of heel syndrome in the postoperative period for carpal tunnel syndrome.
Detailed description
This is a prospective, longitudinal, single-center, open-label observational study conducted on a population of patients operated on for carpal tunnel syndrome.
This study does not alter patient care or the doctor-patient relationship. Evaluations take place during routinely scheduled consultations. The frequency of evaluations is consistent with standard postoperative follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with heel-of-hand syndrome 6 months after surgery for carpal tunnel syndrome | – | –Patients with heel of the hand syndrome, 6 months after surgery for carpal tunnel syndrome (measurement of retinacular ligament thickness intraoperatively) |
| Patients without heel of the hand syndrome 6 months after surgery for carpal tunnel syndrome | – | –Patients without heel of the hand syndrome, 6 months after surgery for carpal tunnel syndrome (measurement of retinacular ligament thickness intraoperatively) |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients operated on for carpal tunnel syndrome by the same operator using the Chow technique.
Key inclusion criteria (3 listed)
- Male or female patient over 18 years of age
- Patient who has been informed of the research and has not indicated their opposition to the use of their medical data
- Patient who is a candidate for first-time carpal tunnel surgery
Key exclusion criteria (5 listed)
- Emergency surgery performed in a post-traumatic context
- Mental impairment or any other reason that may hinder understanding or strict application of the protocol
- Patient not affiliated with the French social security system
- Patient under legal protection, guardianship, or curatorship
- Patient already included in another therapeutic study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare the intraoperative measurement of flexor retinacular ligament thickness between the two groups of patients operated on for carpal tunnel syndrome by the same surgeon using the Chow technique (with and without hand heel syndrome).
Time frame: perioperatively
Intraoperative measurement of flexor retinacular ligament thickness
3 secondary outcomes
Assess the existence of other factors that may be related to the occurrence of hand heel syndrome (Spontaneous pain) according to the initial characteristics and follow-up data of patients with and without hand heel syndrome.
Time frame: Baseline to six months after the surgery
Assess the existence of other factors that may be linked to the occurrence of heel hand syndrome (Pain on palpation of the heel of the hand) based on initial characteristics and follow-up data, patients with and without hand heel syndrome
Time frame: Baseline to six months after the surgery
Assess the existence of other factors that may be linked to the occurrence of heel hand syndrome (Postoperative complications) based on follow-up data, patients with and without hand heel syndrome
Time frame: Immediately after the intervention to six months postoperatory
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 5 Jun 2026.
Related trials for Carpal Tunnel Syndrome (CTS)
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
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 recruitingObservational study
Symptom Recovery Time After the Phalen Test in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS)
Recruiting
Effects of Peripheral Repetitive Peripheral Magnetic Stimulation on Individuals With Elbow or Wrist Chronic Pain
Tennis Elbow Syndrome, Golfer's Elbow
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.
Antonio DINH, Dr principal investigator
Hôpital Privé Paul d'Egine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome (CTS) and Heel Pain Syndrome, 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 3 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 5 Jun 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 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?
Compare the intraoperative measurement of flexor retinacular ligament thickness between the two groups of patients operated on for carpal tunnel syndrome by the same surgeon using the Chow technique (with and without hand heel syndrome). (time frame: perioperatively). 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 5 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.