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

NCT07334964 | Recruiting

• 1 other identifier: CHUO-2025-06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome; robot-assited-ultrasonography; carpal tunnel injection

Outcome Measures

Primary Outcomes (1)

• Comparison of the variation of the VAS scale on the Ultrasound-Guided Carpal Tunnel Injection between the Manual Method and a Robot-Assisted Method

  VAS: Scale 1 to 10 with 1 is no pain at all and 10 is the worst pain that the participant can imagine.

  This outcome is measured on the day of the intervention (Day 0) after randomization and a month after the intervention (Day 28)

Secondary Outcomes (8)

• Pain VAS at D7 and 3 months

  This outcome is measured on Day 0 (D0) after randomization, Day 7 (D7), Day 28 (D28), and Month 3 (M3)

• Compare the evolution of the BCTQ (Boston Carpal Tunnel Questionnaire, subscale SSS) score over time according to the method (Arm A versus Arm B)

  This outcome is measured on Day 0 (D0) after randomization, Day 7 (D7), Day 28 (D28), and Month 3 (M3)

• Compare the evolution of the BCTQ (Boston Carpal Tunnel Questionnaire, subscale FSS) score over time according to the method (Arm A versus Arm B)

  This outcome is measured on Day 0 (D0) after randomization, Day 7 (D7), Day 28 (D28), and Month 3 (M3)

• Compare the duration of the procedure according to the method (Arm A versus Arm B)

  This outcome is measured on Day 0 (D0) after randomization

• Assess the procedure related pain

  This outcome is measured n Day 0 (D0) after randomization and Day 7 (D7),

Study Arms (2)

Manual (Arm A)

ACTIVE COMPARATOR

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.

Procedure: Carpal tunnel injection

Robot-Assisted (Arm B)

EXPERIMENTAL

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.

Procedure: Carpal tunnel injection

Interventions

Carpal tunnel injection PROCEDURE

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.

Manual (Arm A); Robot-Assisted (Arm B)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHU Orléans

Orléans, 45067, France

RECRUITING

Related Publications (10)

• 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.

  PMID: 36980446 BACKGROUND

• 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.

  PMID: 32696280 BACKGROUND

• 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.

  PMID: 25546691 BACKGROUND

• 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.

  PMID: 32151499 BACKGROUND

• 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.

  PMID: 17054773 BACKGROUND

• 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.

  PMID: 38545011 BACKGROUND

• 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.

  PMID: 23475917 BACKGROUND

• 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.

  PMID: 39501897 BACKGROUND

• 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.

  PMID: 37248427 BACKGROUND

• 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.

  PMID: 20670438 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Camille LANGBOUR, Dr

  CHU Orléans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camille LANGBOUR, Dr

CONTACT

0238651450; camille.langbour@chu-orleans.fr

Carine SALLIOT, Pr

CONTACT

0238744014; carine.salliot@chu-orleans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: blinding during injection: a vertical drape blocking the view between the operator and the participant; the robot activated in both groups (noise), noise-reduction system for the patient (noise-canceling headset on the participant's ears, use of earphones, etc.), nurse present in both groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There are 2 arms with an equal number of patient randomized in a parallel way.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 12, 2026
• Study Start: November 25, 2025
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): February 25, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

FR (1)