Overview
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.
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.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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