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Carpal Tunnel SyndromeICCERONCT07334964

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

A study testing Carpal tunnel injection in people with Carpal Tunnel Syndrome, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
Carpal tunnel injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteFrance
Study dates
25 Nov 2025to 15 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU Orléans

    Orléans, 45067

Other trials in France

About this study

Official title: Ultrasound-Guided Carpal Tunnel Infiltration: Comparison Between the Manual Method and a Robot-Assisted Method - A Pilot, Comparative, Randomized Study

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.

Read the detailed 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.

Being tested
Carpal tunnel injection
Keywords
carpal tunnel syndrome, robot-assited-ultrasonography, carpal tunnel injection
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carpal tunnel injectionProcedure or surgery

    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.

Study groups in NCT07334964
Study groupRoleWhat they receive
Manual (Arm A)Active comparatorUltrasound-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.
Receives: Procedure: Carpal tunnel injection
Robot-Assisted (Arm B)ExperimentalUltrasound-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.
Receives: Procedure: Carpal tunnel injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Pain VAS at D7 and 3 months

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

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

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

    Compare the evolution of the Symptom Severity Scale (SSS) score, subscale 1 of BCTQ score. This subscale, the minimum is 11 points (no symptoms) and the maximum is 55 points (maximum severity of symptoms).

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

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

    Compare the evolution of the Functional Status Scale (FSS) score, subscale 2 of BCTQ score. This subscale, the minimum is 8 points (no functional difficulty) and the maximum is 40 points (maximum functional difficulties).

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

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

    Procedure duration, in minutes, measured between initial positioning (first contact of the ultrasound probe with the wrist) and completion of the injection (needle withdrawal).

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

  5. Assess the procedure related pain

    Procedure-related pain measured at D0 immediately after the procedure using a pain VAS; and occurrence of complications such as hematoma or inflammatory reaction, assessed at D7. For VAS scale, the minimum value is 0 (no pain) and the maximum value is 10 (worst pain imaginable)

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

  6. Assess patient satisfaction ("appreciation") regarding the robotic arm

    Patient satisfaction ("appreciation") questionnaire regarding the robotic-assisted procedure at D0 (before the procedure). The "questionnaire d'appréciation de la procédure robotisée" questionnaire is specific for this study.

    Measured: This outcome is measured on Day 0 (D0) after randomization an before the procedure (carpal tunnel injection)

  7. Assess the acceptability of patients participating in the study

    Number of patients screened (inclusion visit), number of patients who agreed to participate in the study.

    Measured: This outcomme i measured at the end of the study

  8. Compare analgesic consumption related to carpal tunnel syndrome over time

    Analgesic consumption (number/type/frequency), including step 1-3 analgesics, tricyclic antidepressants, and gabapentinoids, assessed at D0, D7, D28, and M3.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2026
  2. Study start25 Nov 2025
  3. Primary completion15 Jul 2026
  4. Study completion15 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
There are 2 arms with an equal number of patient randomized in a parallel way.
Masking
Single blind
Who is masked
Participant
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07334964
Sponsor's protocol ID
CHUO-2025-06
Acronym
ICCERO
Status last verified
Jul 2026
First submitted
22 Dec 2025
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36980446
  • 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.

    PubMed 32696280
  • 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.

    PubMed 25546691
  • 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.

    PubMed 32151499
  • 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.

    PubMed 17054773
  • 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.

    PubMed 38545011
  • 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.

    PubMed 23475917
  • 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.

    PubMed 39501897
  • 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.

    PubMed 37248427
  • 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.

    PubMed 20670438

Questions about this trial

What is this clinical trial studying?

A study testing Carpal tunnel injection in people with Carpal Tunnel Syndrome, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the variation of the VAS scale on the Ultrasound-Guided Carpal Tunnel Injection between the Manual Method and a Robot-Assisted Method (time frame: This outcome is measured on the day of the intervention (Day 0) after randomization and a month after the intervention (Day 28)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07334964, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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