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Short- to Medium-term Outcome of Minimally Invasive Carpal Tunnel Release

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06997172
Enrollment
61
Registered
2025-05-30
Start date
2025-05-31
Completion date
2026-09-30
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel

Keywords

Percutaneous sonography guided release

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURETCTR (thread carpal tunnel release)

Percutaneous sonography guided release of carpal tunnel release

PROCEDUREStandard-of-care

Open or endoscopic carpal tunnel release based on patients' and physicians' preferences

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient aged 18 years or older * Electroneurographically proven carpal tunnel syndrome * Informed Consent for trial participation

Exclusion criteria

* Revision surgery * Inability to give informed consent, whether it be due to an insurmountable language barrier or another reason

Design outcomes

Primary

MeasureTime frameDescription
The objective functional assessment of the BCTQ score at 2 weeks2 weeks post-operativeFunctional 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.

Secondary

MeasureTime frameDescription
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-operativeThe 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.
The subjective symptom severity score of the BCTQ2, 4 and 6 weeks and 6 months post-operativeThe 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.
Hand-specific health2, 4 and 6 weeks and 6 months post-operativeThe 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.
Functional recovery timeup to 6 months post-operativeDays until return to daily activities and/or work
Recovery from painup to 6 months post-operativeDays until discontinuation of pain medication
Area of the median nerve2, 4 and 6 weeks and 6 months post-operativeCross sectional area of the median nerve (cm2) is investigatad by sonographic
Range of motion2, 4 and 6 weeks and 6 months post-operativeRange of motion in degrees
The objective functional assessment of the BCTQ score4 and 6 weeks and 6 month post-operativeFunctional 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
Strength in the abductor pollicis brevis2, 4 and 6 weeks and 6 months post-operativeForce 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.
Two-point discrimination2, 4 and 6 weeks and 6 months post-operativetwo-point discrimination in millimeter
Grip strength2, 4 and 6 weeks and 6 months post-operativeGrip strength is measured with the Jamar dynamometer
Pinch strength2, 4 and 6 weeks and 6 months post-operativePinch strength is measured with the Jamar dynamometer
Pain intensity2, 4 and 6 weeks and 6 months post-operativePain measured with the visual analog scale (VAS) from 0-10
Outcome satisfaction2, 4 and 6 weeks and 6 months post-operativePatient satisfaction measured with the VAS from 0-10
thenar atrophies2, 4 and 6 weeks and 6 months post-operativePresence of thenar atrophies (yes / no)

Countries

Switzerland

Contacts

Primary ContactSaskia Kamphuis, MD
Saskia.Kamphuis@usb.ch+41 61 556 54 82

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026