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NCT Number: NCT07334964

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

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

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

Secondary outcomes

  1. Pain VAS at D7 and 3 months

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

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

  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)

    Time frame: 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 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).

  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)

    Time frame: 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 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).

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

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

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

  5. Assess the procedure related pain

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

    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)

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

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

    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.

  7. Assess the acceptability of patients participating in the study

    Time frame: This outcomme i measured at the end of the study

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

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Camille LANGBOUR, Dr

CONTACT

[email protected]

0238651450 ext. +33

Carine SALLIOT, Pr

CONTACT

[email protected]

0238744014 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: ICCERO

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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