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

Centre Hospitalier Régional d'Orléans

Status: Enrolling

Conditions: Carpal Tunnel Syndrome

Treatments: Procedure: Carpal tunnel injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07334964

CHUO-2025-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Manual (Arm A)

Active Comparator group

Description:

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.

Treatment:

Procedure: Carpal tunnel injection

Robot-Assisted (Arm B)

Experimental group

Description:

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.

Treatment:

Procedure: Carpal tunnel injection