Robot-assisted versus manual ultrasound-guided carpal tunnel injection
Ultrasound-Guided Carpal Tunnel Infiltration: Comparison Between the Manual Method and a Robot-Assisted Method - A Pilot, Comparative, Randomized Study
This study will test whether using a robotic arm to hold the ultrasound probe makes steroid injections for adults with carpal tunnel syndrome easier, safer, or more accurate than the usual manual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Régional d'Orléans Academic / other |
| Locations | 1 site (Orléans) |
| Trial ID | NCT07334964 on ClinicalTrials.gov |
What this trial studies
Adults with clinically diagnosed moderate to severe carpal tunnel syndrome who need a corticosteroid injection will receive an ultrasound-guided injection with either the usual manual probe holding or with the ultrasound probe held by a robotic arm. The robotic arm is used to maintain probe position during the injection, removing the need for a third person to hold the probe. Follow-up at day 7, day 28 and three months will collect pain VAS scores, the Boston Carpal Tunnel Questionnaire, and patient satisfaction by phone, teleconsultation, or clinic visit. The trial will record feasibility, safety events, and measures of injection accuracy to inform a larger future study.
Who should consider this trial
Good fit: Adults aged 18–75 with a clinical diagnosis of carpal tunnel syndrome, a baseline pain VAS ≥ 4, and a clinical indication for corticosteroid injection are ideal candidates.
Not a fit: Patients with prior carpal tunnel surgery, thenar eminence atrophy, recent injection in the affected wrist, active infection, allergy to study materials, pregnancy, or other listed exclusions would not be eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, the robotic probe holder could streamline the injection procedure, reduce staff needs, and possibly improve injection accuracy and patient comfort.
How similar studies have performed: Direct comparisons of robot-assisted probe holding versus manual ultrasound-guided carpal tunnel injections have not been published, so this approach is largely novel in this indication.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Orléans
- CHU Orléans — Orléans, France (Recruiting)
Study contacts
- Principal investigator: Camille LANGBOUR, Dr — CHU Orléans
- Study coordinator: Camille LANGBOUR, Dr
- Email: camille.langbour@chu-orleans.fr
- Phone: 0238651450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.