Determining the Short- to Medium-term Outcome After Minimally Invasive Sonography Guided Release of the Carpal Tunnel Compared to Standard-of-care Open and Endoscopic Techniques: a Randomized Controlled Superiority Trial With an Internal Pilot-phase
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- The objective functional assessment of the BCTQ score at 2 weeks
研究概览
简要总结
The aim of the study is to determine whether minimally invasive, ultrasound-guided thread carpal tunnel release leads to faster functional recovery compared to standard open and endoscopic techniques in patients with carpal tunnel syndrome.
详细描述
Carpal tunnel syndrome (CTS) is the most common peripheral nerve compression disorder encountered in hand surgery. It affects a broad demographic, from young women (often linked to pregnancy and breastfeeding) and young men involved in manual labor, to elderly individuals. The condition causes pain, numbness, and functional impairment in the hand, which can progress to permanent disability if untreated. Typically, conservative treatment (e.g., night splints, corticosteroid injections) is the first step. However, when symptoms persist, surgical decompression of the median nerve becomes necessary.
The current gold standard for surgical treatment of CTS is open carpal tunnel release (OCTR). This involves making a 2-5 cm incision in the palm and cutting the transverse carpal ligament under direct vision. While effective in relieving nerve compression, this approach creates a scar in the load-bearing area of the palm, which can lead to prolonged post-operative pain, delayed wound healing, reduced grip strength, extended rehabilitation time and limitations in early hand use.
To address some of these drawbacks, endoscopic carpal tunnel release (ECTR) was developed. This technique uses a smaller incision at the wrist and a camera system to visualize and divide the ligament. While less invasive than OCTR, ECTR still involves an incision, and significant scar tissue may still develop, especially internally.
Both techniques require postoperative wound care, stitch removal, and carry risks of complications such as nerve or tendon injury, infection, or incomplete release. Additionally, these methods often result in delays in returning to work and daily activities, particularly burdensome for patients in physically demanding jobs.
In recent years, a novel percutaneous ultrasound-guided technique, known as thread carpal tunnel release (TCTR), has been introduced. This method uses two small puncture sites instead of incisions. Under real-time ultrasound guidance, a suture loop is passed around the transverse carpal ligament, which is then divided using a sawing motion. This technique bears several advantages including absence of external scar, reduced postoperative pain, no requirement for stitch removal, potential faster recovery allowing earlier return to normal function, daily activities and work.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 years or older
- •Electroneurographically proven carpal tunnel syndrome
- •Informed Consent for trial participation
排除标准
- •Revision surgery
- •Inability to give informed consent, whether it be due to an insurmountable language barrier or another reason
研究组 & 干预措施
TCTR (thread carpal tunnel release)
Percutaneous sonography guided release of carpal tunnel
干预措施: TCTR (thread carpal tunnel release) (Procedure)
Standard of care technique
Standard of care technique (consisting of either the open or endoscopic technique) release of carpal tunnel
干预措施: Standard-of-care (Procedure)
结局指标
主要结局
The objective functional assessment of the BCTQ score at 2 weeks
时间窗: 2 weeks post-operative
Functional assessment of the BCTQ. The BCTQ is a patient reported outcome measure (PROM) questionnaire that examines subjective symptom severity and objective overall functional status. The Functional Status Scale evaluates the ability of the patient to use their hand in daily life using 8 questions, which are scored from 1-5 with 1 as no difficulty and 5 as difficult. Therefore, the higher the score, the more difficulty the patient has with the symptom.
次要结局
- Pain intensity(2, 4 and 6 weeks and 6 months post-operative)
- Recovery from pain(up to 6 months post-operative)
- Pinch strength(2, 4 and 6 weeks and 6 months post-operative)
- Outcome satisfaction(2, 4 and 6 weeks and 6 months post-operative)
- The objective functional assessment of the BCTQ score(4 and 6 weeks and 6 month post-operative)
- Overall BCTQ score, which is a combination of the subjective symptom severity and the objective functional status.(2, 4 and 6 weeks and 6 months post-operative)
- The subjective symptom severity score of the BCTQ(2, 4 and 6 weeks and 6 months post-operative)
- Hand-specific health(2, 4 and 6 weeks and 6 months post-operative)
- Two-point discrimination(2, 4 and 6 weeks and 6 months post-operative)
- Grip strength(2, 4 and 6 weeks and 6 months post-operative)
- Functional recovery time(up to 6 months post-operative)
- Area of the median nerve(2, 4 and 6 weeks and 6 months post-operative)
- Range of motion(2, 4 and 6 weeks and 6 months post-operative)
- thenar atrophies(2, 4 and 6 weeks and 6 months post-operative)
- Strength in the abductor pollicis brevis(2, 4 and 6 weeks and 6 months post-operative)
