Ultrasound-Guided Carpal Tunnel Infiltration: Comparison Between the Manual Method and a Robot-Assisted Method
NCT ID: NCT07334964
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-11-25
2027-02-25
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Centre Hospitalier Régional d'Orléans
OTHER
Responsible Party
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Principal Investigators
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Camille LANGBOUR, Dr
Role: PRINCIPAL_INVESTIGATOR
CHU Orléans
Locations
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CHU Orléans
Orléans, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Lam KHS, Wu YT, Reeves KD, Galluccio F, Allam AE, Peng PWH. Ultrasound-Guided Interventions for Carpal Tunnel Syndrome: A Systematic Review and Meta-Analyses. Diagnostics (Basel). 2023 Mar 16;13(6):1138. doi: 10.3390/diagnostics13061138.
Goswami RP, Sit H, Chatterjee M, Lahiri D, Sircar G, Ghosh P. High-resolution ultrasonography in carpal tunnel syndrome: role of ancillary criteria in diagnosis and response to steroid injection. Clin Rheumatol. 2021 Mar;40(3):1069-1076. doi: 10.1007/s10067-020-05228-8. Epub 2020 Jul 21.
Lee JY, Park Y, Park KD, Lee JK, Lim OK. Effectiveness of ultrasound-guided carpal tunnel injection using in-plane ulnar approach: a prospective, randomized, single-blinded study. Medicine (Baltimore). 2014 Dec;93(29):e350. doi: 10.1097/MD.0000000000000350.
Mehta SP, Weinstock-Zlotnick G, Akland KL, Hanna MM, Workman KJ. Using Carpal Tunnel Questionnaire in clinical practice: A systematic review of its measurement properties. J Hand Ther. 2020 Oct-Dec;33(4):493-506. doi: 10.1016/j.jht.2019.12.011. Epub 2020 Mar 7.
Leite JC, Jerosch-Herold C, Song F. A systematic review of the psychometric properties of the Boston Carpal Tunnel Questionnaire. BMC Musculoskelet Disord. 2006 Oct 20;7:78. doi: 10.1186/1471-2474-7-78.
Jiang A, Qian Y, Yan J, Zhang S, Zhu S. Corticosteroid injection for carpal tunnel syndrome: A meta-analysis comparing ultrasound guided approach with landmark approach. Pak J Med Sci. 2024 Mar-Apr;40(4):773-778. doi: 10.12669/pjms.40.4.8749.
Priester AM, Natarajan S, Culjat MO. Robotic ultrasound systems in medicine. IEEE Trans Ultrason Ferroelectr Freq Control. 2013 Mar;60(3):507-23. doi: 10.1109/TUFFC.2013.2593.
Scheibert A, Preuss M, Osburg J, Ernst F, Kleemann M, Horn M. Robotic Assisted Ultrasound-Guided Endovascular Stent Implantation in a Vascular Model. Int J Med Robot. 2024 Dec;20(6):e70005. doi: 10.1002/rcs.70005.
Eilers C, van Kemenade R, Busam B, Navab N. On the importance of patient acceptance for medical robotic imaging. Int J Comput Assist Radiol Surg. 2023 Jul;18(7):1261-1267. doi: 10.1007/s11548-023-02948-5. Epub 2023 May 29.
Peters-Veluthamaningal C, Winters JC, Groenier KH, Meyboom-de Jong B. Randomised controlled trial of local corticosteroid injections for carpal tunnel syndrome in general practice. BMC Fam Pract. 2010 Jul 29;11:54. doi: 10.1186/1471-2296-11-54.
Other Identifiers
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CHUO-2025-06
Identifier Type: -
Identifier Source: org_study_id
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