University Hospital Basel
Basel, 4031, Switzerland
NCT Number: NCT06997172
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Basel, 4031, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Percutaneous sonography guided release of carpal tunnel release
Open or endoscopic carpal tunnel release based on patients' and physicians' preferences
Time frame: 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.
Time frame: 4 and 6 weeks and 6 month 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
Time frame: 2, 4 and 6 weeks and 6 months post-operative
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 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.
Time frame: 2, 4 and 6 weeks and 6 months post-operative
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: up to 6 months post-operative
Days until return to daily activities and/or work
Time frame: up to 6 months post-operative
Days until discontinuation of pain medication
Time frame: 2, 4 and 6 weeks and 6 months post-operative
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 in degrees
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Presence of thenar atrophies (yes / no)
Time frame: 2, 4 and 6 weeks and 6 months post-operative
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 in millimeter
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Grip strength is measured with the Jamar dynamometer
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Pinch strength is measured with the Jamar dynamometer
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Pain measured with the visual analog scale (VAS) from 0-10
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Patient satisfaction measured with the VAS from 0-10
Contact information is provided by the study sponsor or research team.
University Hospital, Basel, Switzerland
Other
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
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