Ultrasound-Guided Carpal Tunnel Infiltration: Comparison Between the Manual Method and a Robot-Assisted Method - A Pilot, Comparative, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Comparison of the variation of the VAS scale on the Ultrasound-Guided Carpal Tunnel Injection between the Manual Method and a Robot-Assisted Method
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Manual (Arm A)
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.
干预措施: Carpal tunnel injection (Procedure)
Robot-Assisted (Arm B)
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.
干预措施: Carpal tunnel injection (Procedure)
结局指标
主要结局
Comparison of the variation of the VAS scale on the Ultrasound-Guided Carpal Tunnel Injection between the Manual Method and a Robot-Assisted Method
时间窗: 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.
次要结局
- 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),)
- 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))
- Assess the acceptability of patients participating in the study(This outcomme i measured at the end of the study)
- 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))
- 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),)
- 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))
- Assess the acceptability of patients participating in the study(This outcomme i measured at the end of 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))