Find Carpal Tunnel Syndrome Clinical Trials Near You
Ultrasound-Guided Carpal Tunnel Infiltration: Comparison Between the Manual Method and a Robot-Assisted Method - A Pilot, Comparative, Randomized Study
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
France
CHU Orléans
RECRUITING
Orléans
Contact Information
Primary
Camille LANGBOUR, Dr
camille.langbour@chu-orleans.fr
0238651450
Backup
Carine SALLIOT, Pr
carine.salliot@chu-orleans.fr
0238744014
Time Frame
Start Date:2025-11-25
Estimated Completion Date:2027-02-25
Participants
Target number of participants:20
Treatments
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.
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.