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.
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. The theoretical benefits of TCTR are supported by cadaveric and small clinical studies, but no large randomized controlled trials have yet compared TCTR directly with both open and endoscopic techniques. This study aims to fill that evidence gap by rigorously evaluating whether TCTR leads to quicker functional recovery, measured via validated functional assessments in a real-world clinical setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Percutaneous sonography guided release of carpal tunnel release
Open or endoscopic carpal tunnel release based on patients' and physicians' preferences
University Hospital Basel
Basel, Switzerland
The objective functional assessment of the BCTQ score at 2 weeks
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.
Time frame: 2 weeks post-operative
The objective functional assessment of the BCTQ score
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
Time frame: 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.
The BCTQ is a patient reported outcome measure (PROM) questionnaire that examines subjective symptom severity and objective overall functional status. The Symptom Severity Scale with 11 questions is scored on a Likert scale of 1-5 and the Functional Status Scale with 8 questions is 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.
Time frame: 2, 4 and 6 weeks and 6 months post-operative
The subjective symptom severity score of the BCTQ
The BCTQ is a patient reported outcome measure (PROM) questionnaire that examines subjective symptom severity and objective overall functional status. The Symptom Severity Scale describes the symptoms concerning sensibility and pain and is evaluated using 11 questions scored on a Likert scale of 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Hand-specific health
The Michigan Hand Questionnaire (MHQ)is one of the most widely utilized, hand-specific surveys that measures health status relevant to patients with acute and chronic hand disorders.Scale ranges from 0-100, while lower scores indicate better outcomes.
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Functional recovery time
Days until return to daily activities and/or work
Time frame: up to 6 months post-operative
Recovery from pain
Days until discontinuation of pain medication
Time frame: up to 6 months post-operative
Area of the median nerve
Cross sectional area of the median nerve (cm2) is investigatad by sonographic
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Range of motion
Range of motion in degrees
Time frame: 2, 4 and 6 weeks and 6 months post-operative
thenar atrophies
Presence of thenar atrophies (yes / no)
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Strength in the abductor pollicis brevis
Force Abductor pollicis brevis in Medical Research Council (MCR) grade. The force produced by the abductor pollicis brevis (APB) muscle is graded using the Medical Research Council (MRC) scale, which assesses muscle strength, ranging vrom 0-5. A grade 5 indicates full strength and normal function, while lower grades indicate varying degrees of weakness.
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Two-point discrimination
two-point discrimination in millimeter
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Grip strength
Grip strength is measured with the Jamar dynamometer
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Pinch strength
Pinch strength is measured with the Jamar dynamometer
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Pain intensity
Pain measured with the visual analog scale (VAS) from 0-10
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Outcome satisfaction
Patient satisfaction measured with the VAS from 0-10
Time frame: 2, 4 and 6 weeks and 6 months post-operative