Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06997172

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TCTR (thread carpal tunnel release)

Procedure

Percutaneous sonography guided release of carpal tunnel release

Standard-of-care

Procedure

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

Primary outcomes

  1. The objective functional assessment of the BCTQ score at 2 weeks

    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.

Secondary outcomes

  1. The objective functional assessment of the BCTQ score

    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

  2. Overall BCTQ score, which is a combination of the subjective symptom severity and the objective functional status.

    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.

  3. The subjective symptom severity score of the BCTQ

    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.

  4. Hand-specific health

    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.

  5. Functional recovery time

    Time frame: up to 6 months post-operative

    Days until return to daily activities and/or work

  6. Recovery from pain

    Time frame: up to 6 months post-operative

    Days until discontinuation of pain medication

  7. Area of the median nerve

    Time frame: 2, 4 and 6 weeks and 6 months post-operative

    Cross sectional area of the median nerve (cm2) is investigatad by sonographic

  8. Range of motion

    Time frame: 2, 4 and 6 weeks and 6 months post-operative

    Range of motion in degrees

  9. thenar atrophies

    Time frame: 2, 4 and 6 weeks and 6 months post-operative

    Presence of thenar atrophies (yes / no)

  10. Strength in the abductor pollicis brevis

    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.

  11. Two-point discrimination

    Time frame: 2, 4 and 6 weeks and 6 months post-operative

    two-point discrimination in millimeter

  12. Grip strength

    Time frame: 2, 4 and 6 weeks and 6 months post-operative

    Grip strength is measured with the Jamar dynamometer

  13. Pinch strength

    Time frame: 2, 4 and 6 weeks and 6 months post-operative

    Pinch strength is measured with the Jamar dynamometer

  14. Pain intensity

    Time frame: 2, 4 and 6 weeks and 6 months post-operative

    Pain measured with the visual analog scale (VAS) from 0-10

  15. Outcome satisfaction

    Time frame: 2, 4 and 6 weeks and 6 months post-operative

    Patient satisfaction measured with the VAS from 0-10

Study contacts

Contact information is provided by the study sponsor or research team.

Saskia Kamphuis, MD

CONTACT

[email protected]

+41 61 556 54 82

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 30, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.