Ultrasound-Guided Carpal Tunnel Infiltration: Comparison Between the Manual Method and a Robot-Assisted Method (ICCERO)

January 6, 2026 updated by: Centre Hospitalier Régional d'Orléans

Ultrasound-Guided Carpal Tunnel Infiltration: Comparison Between the Manual Method and a Robot-Assisted Method - A Pilot, Comparative, Randomized Study

This study aims to assess the feasibility, safety, and accuracy of a robotic arm-assisted carpal tunnel injection in comparison with the conventional ultrasound-guided method, prior to conducting a larger-scale study.

The use of a robotic arm to maintain the ultrasound probe in position could provide valuable assistance to the physician. The procedure would no longer require the involvement of a third person in addition to the physician. To date, no study has compared these two approaches.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be offered to patients suffering from carpal tunnel syndrome who are followed for this condition in a rheumatology setting. The carpal tunnel injection, as well as identification of the injection site using an ultrasound probe, will be performed by the practitioner according to standard clinical practice.

Maintaining the ultrasound probe during the injection will constitute the research-specific procedure (standard practice in Group A versus a research-specific procedure with probe holding by the robotic arm in Group B). Follow-up visits (at Day 7, Day 28 and 3 months after carpal tunnel injection) conducted via phone call, teleconsultation or consultation will also be research-specific procedures, as will completion of the pain VAS (Visual Analogue Scale), the BQCT (Boston carpal tunnel syndrome questionnaire) self-administered questionnaire, and the participant satisfaction questionnaire.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 75 years.
  2. Clinical diagnosis of carpal tunnel syndrome.
  3. Indication for corticosteroid injection as determined by investigator.
  4. Moderate to severe carpal tunnel syndrome defined by a pain score on the Visual Analogue Scale (VAS) ≥ 4 (at baseline and on day 0).
  5. Signed informed consent.

Exclusion Criteria:

  1. Known allergy to corticosteroids or povidone-iodine (Betadine)
  2. Probable or ongoing systemic or local infection
  3. History of injection in the affected wrist within the last 6 months
  4. Thenar eminence atrophy
  5. Trauma requiring surgery or immobilization
  6. History of carpal tunnel surgery
  7. Protected person (under guardianship or curatorship)
  8. Person under judicial protection
  9. Person deprived of liberty
  10. Person not affiliated with a social security scheme
  11. Pregnant or breastfeeding woman
  12. Person participating in a drug trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Manual (Arm A)

Ultrasound-guided carpal tunnel injection using the conventional method:

An ultrasound-guided carpal tunnel injection is performed using manual guidance. The operator first identifies the median nerve using an ultrasound probe. The operator then applies aseptic conditions. Subsequently, the operator holds the ultrasound probe in one hand and the medication in the other, and performs the injection while referring to the ultrasound image to ensure accurate needle placement.
Procedure: Carpal tunnel injection

Ultrasound localization will be performed by the physician. He will then perform the injection under ultrasound guidance. In Group A, maintenance of the ultrasound probe during the injection will be performed by the physician assisted by a nurse. In Group B, maintenance of the ultrasound probe during the injection will be performed by the robotic arm.

All other aspects of the procedure will be carried out according to usual standards (localization, aseptic technique, injection, etc…). The procedure will be timed from the initial positioning (first contact of the ultrasound probe with the wrist) to the end of the injection (needle withdrawal).

Maintenance of participant blinding during the injection: a drape will be placed between the physician and the participant; the robot will be activated in both groups, the participant will wear anti noise headphones, and a nurse will be present in both groups.
Experimental: Robot-Assisted (Arm B)

Ultrasound-guided carpal tunnel injection assisted by a robotic arm:

The operator first identifies the median nerve using an ultrasound probe tied back to the robotic arm. The operator then places both themselves and the probe attached robotic arm under aseptic conditions. The robotic arm is subsequently positioned to obtain the desired ultrasound imaging plane. The operator then has both hands free to perform the injection, referring to the ultrasound image to ensure accurate needle placement.
Procedure: Carpal tunnel injection

Ultrasound localization will be performed by the physician. He will then perform the injection under ultrasound guidance. In Group A, maintenance of the ultrasound probe during the injection will be performed by the physician assisted by a nurse. In Group B, maintenance of the ultrasound probe during the injection will be performed by the robotic arm.

All other aspects of the procedure will be carried out according to usual standards (localization, aseptic technique, injection, etc…). The procedure will be timed from the initial positioning (first contact of the ultrasound probe with the wrist) to the end of the injection (needle withdrawal).

Maintenance of participant blinding during the injection: a drape will be placed between the physician and the participant; the robot will be activated in both groups, the participant will wear anti noise headphones, and a nurse will be present in both groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the variation of the VAS scale on the Ultrasound-Guided Carpal Tunnel Injection between the Manual Method and a Robot-Assisted Method
Time Frame: This outcome is measured on the day of the intervention (Day 0) after randomization and a month after the intervention (Day 28)
VAS: Scale 1 to 10 with 1 is no pain at all and 10 is the worst pain that the participant can imagine.
This outcome is measured on the day of the intervention (Day 0) after randomization and a month after the intervention (Day 28)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain VAS at D7 and 3 months
Time Frame: This outcome is measured on Day 0 (D0) after randomization, Day 7 (D7), Day 28 (D28), and Month 3 (M3)
VAS: Scale 1 to 10 with 1 is no pain at all and 10 is the worst pain that the participant can imagine.
This outcome is measured on Day 0 (D0) after randomization, Day 7 (D7), Day 28 (D28), and Month 3 (M3)
Compare the evolution of the BCTQ (Boston Carpal Tunnel Questionnaire, subscale SSS) score over time according to the method (Arm A versus Arm B)
Time Frame: This outcome is measured on Day 0 (D0) after randomization, Day 7 (D7), Day 28 (D28), and Month 3 (M3)
Compare the evolution of the Symptom Severity Scale (SSS) score, subscale 1 of BCTQ score. This subscale, the minimum is 11 points (no symptoms) and the maximum is 55 points (maximum severity of symptoms).
This outcome is measured on Day 0 (D0) after randomization, Day 7 (D7), Day 28 (D28), and Month 3 (M3)
Compare the evolution of the BCTQ (Boston Carpal Tunnel Questionnaire, subscale FSS) score over time according to the method (Arm A versus Arm B)
Time Frame: This outcome is measured on Day 0 (D0) after randomization, Day 7 (D7), Day 28 (D28), and Month 3 (M3)
Compare the evolution of the Functional Status Scale (FSS) score, subscale 2 of BCTQ score. This subscale, the minimum is 8 points (no functional difficulty) and the maximum is 40 points (maximum functional difficulties).
This outcome is measured on Day 0 (D0) after randomization, Day 7 (D7), Day 28 (D28), and Month 3 (M3)
Compare the duration of the procedure according to the method (Arm A versus Arm B)
Time Frame: This outcome is measured on Day 0 (D0) after randomization
Procedure duration, in minutes, measured between initial positioning (first contact of the ultrasound probe with the wrist) and completion of the injection (needle withdrawal).
This outcome is measured on Day 0 (D0) after randomization
Assess the procedure related pain
Time Frame: This outcome is measured n Day 0 (D0) after randomization and Day 7 (D7),
Procedure-related pain measured at D0 immediately after the procedure using a pain VAS; and occurrence of complications such as hematoma or inflammatory reaction, assessed at D7. For VAS scale, the minimum value is 0 (no pain) and the maximum value is 10 (worst pain imaginable)
This outcome is measured n Day 0 (D0) after randomization and Day 7 (D7),
Assess patient satisfaction ("appreciation") regarding the robotic arm
Time Frame: This outcome is measured on Day 0 (D0) after randomization an before the procedure (carpal tunnel injection)
Patient satisfaction ("appreciation") questionnaire regarding the robotic-assisted procedure at D0 (before the procedure). The "questionnaire d'appréciation de la procédure robotisée" questionnaire is specific for this study.
This outcome is measured on Day 0 (D0) after randomization an before the procedure (carpal tunnel injection)
Assess the acceptability of patients participating in the study
Time Frame: This outcomme i measured at the end of the study
Number of patients screened (inclusion visit), number of patients who agreed to participate in the study.
This outcomme i measured at the end of the study
Compare analgesic consumption related to carpal tunnel syndrome over time
Time Frame: This outcome is measured on Day 0 (D0) after randomization, Day 7 (D7), Day 28 (D28), and Month 3 (M3)
Analgesic consumption (number/type/frequency), including step 1-3 analgesics, tricyclic antidepressants, and gabapentinoids, assessed at D0, D7, D28, and M3.
This outcome is measured on Day 0 (D0) after randomization, Day 7 (D7), Day 28 (D28), and Month 3 (M3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Camille LANGBOUR, Dr, CHU Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2025

Primary Completion (Estimated)

November 25, 2026

Study Completion (Estimated)

February 25, 2027

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUO-2025-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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