Ultrasound-Guided Carpal Tunnel Infiltration: Comparison Between the Manual Method and a Robot-Assisted Method
Ultrasound-Guided Carpal Tunnel Infiltration: Comparison Between the Manual Method and a Robot-Assisted Method - A Pilot, Comparative, Randomized Study
Centre Hospitalier Régional d'Orléans
20 participants
Nov 25, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- Age ≥ 18 and ≤ 75 years.
- Clinical diagnosis of carpal tunnel syndrome.
- Indication for corticosteroid injection as determined by investigator.
- Moderate to severe carpal tunnel syndrome defined by a pain score on the Visual Analogue Scale (VAS) ≥ 4 (at baseline and on day 0).
- Signed informed consent.
Exclusion Criteria12
- Known allergy to corticosteroids or povidone-iodine (Betadine)
- Probable or ongoing systemic or local infection
- History of injection in the affected wrist within the last 6 months
- Thenar eminence atrophy
- Trauma requiring surgery or immobilization
- History of carpal tunnel surgery
- Protected person (under guardianship or curatorship)
- Person under judicial protection
- Person deprived of liberty
- Person not affiliated with a social security scheme
- Pregnant or breastfeeding woman
- Person participating in a drug trial
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Interventions
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.
Locations(1)
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NCT07334964