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Carpal TunnelNCT06997172

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

A study testing TCTR (thread carpal tunnel release) and Standard-of-care in people with Carpal Tunnel, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carpal Tunnel
What is being tested?
TCTR (thread carpal tunnel release) and Standard-of-care
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteSwitzerland
Study dates
May 2025to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Saskia Kamphuis, MD contact

+41 61 556 54 82

Saskia.Kamphuis@usb.ch

Switzerland1 site
  • University Hospital Basel

    Basel, 4031

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

Other trials in Switzerland

About this study

Official 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

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.

Read the 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.

Conditions
Carpal Tunnel
Being tested
TCTR (thread carpal tunnel release), Standard-of-care
Keywords
Percutaneous sonography guided release
Medical subject headings
Median Neuropathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TCTR (thread carpal tunnel release)Procedure or surgery

    Percutaneous sonography guided release of carpal tunnel release

  • Standard-of-careProcedure or surgery

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

Study groups in NCT06997172
Study groupRoleWhat they receive
TCTR (thread carpal tunnel release)ExperimentalPercutaneous sonography guided release of carpal tunnel
Receives: Procedure: TCTR (thread carpal tunnel release)
Standard of care techniqueActive comparatorStandard of care technique (consisting of either the open or endoscopic technique) release of carpal tunnel
Receives: Procedure: Standard-of-care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 weeks post-operative

Secondary outcomes (15)
  1. 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

    Measured: 4 and 6 weeks and 6 month post-operative

  2. 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.

    Measured: 2, 4 and 6 weeks and 6 months post-operative

  3. 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.

    Measured: 2, 4 and 6 weeks and 6 months post-operative

  4. 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.

    Measured: 2, 4 and 6 weeks and 6 months post-operative

  5. Functional recovery time

    Days until return to daily activities and/or work

    Measured: up to 6 months post-operative

  6. Recovery from pain

    Days until discontinuation of pain medication

    Measured: up to 6 months post-operative

  7. Area of the median nerve

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

    Measured: 2, 4 and 6 weeks and 6 months post-operative

  8. Range of motion

    Range of motion in degrees

    Measured: 2, 4 and 6 weeks and 6 months post-operative

  9. thenar atrophies

    Presence of thenar atrophies (yes / no)

    Measured: 2, 4 and 6 weeks and 6 months post-operative

  10. 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.

    Measured: 2, 4 and 6 weeks and 6 months post-operative

  11. Two-point discrimination

    two-point discrimination in millimeter

    Measured: 2, 4 and 6 weeks and 6 months post-operative

  12. Grip strength

    Grip strength is measured with the Jamar dynamometer

    Measured: 2, 4 and 6 weeks and 6 months post-operative

  13. Pinch strength

    Pinch strength is measured with the Jamar dynamometer

    Measured: 2, 4 and 6 weeks and 6 months post-operative

  14. Pain intensity

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

    Measured: 2, 4 and 6 weeks and 6 months post-operative

  15. Outcome satisfaction

    Patient satisfaction measured with the VAS from 0-10

    Measured: 2, 4 and 6 weeks and 6 months post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06997172
Sponsor's protocol ID
2025-00406; mu25Kamphuis
Other IDs
2025
Status last verified
May 2025
First submitted
21 May 2025
Last updated
30 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing TCTR (thread carpal tunnel release) and Standard-of-care in people with Carpal Tunnel, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Saskia Kamphuis, MD (+41 61 556 54 82, Saskia.Kamphuis@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The objective functional assessment of the BCTQ score at 2 weeks (time frame: 2 weeks post-operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.

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