Carpal Tunnel Syndrome
Conditions
Keywords
carpal tunnel syndrome, robot-assited-ultrasonography, carpal tunnel injection
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.
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.
Interventions
PROCEDURECarpal 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.
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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
Intervention model description
There are 2 arms with an equal number of patient randomized in a parallel way.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 and ≤ 75 years. 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
1. Known allergy to corticosteroids or povidone-iodine (Betadine) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the variation of the VAS scale on the Ultrasound-Guided Carpal Tunnel Injection between the Manual Method and a Robot-Assisted Method | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | VAS: Scale 1 to 10 with 1 is no pain at all and 10 is the worst pain that the participant can imagine. |
| 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 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). |
| 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 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). |
| 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 | Procedure duration, in minutes, measured between initial positioning (first contact of the ultrasound probe with the wrist) and completion of the injection (needle withdrawal). |
| Assess the procedure related pain | 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) |
| Assess patient satisfaction ("appreciation") regarding the robotic arm | 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. |
| Assess the acceptability of patients participating in the study | 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. |
| Compare analgesic consumption related to carpal tunnel syndrome over time | 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORCamille LANGBOUR, Dr
CHU Orléans
Outcome results
None listed