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.
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.
Switzerland1 site
University Hospital Basel
Basel, 4031
Saskia Kamphuis, MD, +41 61 556 54 82, Saskia.Kamphuis@usb.ch
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 group | Role | What they receive |
|---|---|---|
| TCTR (thread carpal tunnel release) | Experimental | Percutaneous sonography guided release of carpal tunnel Receives: Procedure: TCTR (thread carpal tunnel release) |
| Standard of care technique | Active comparator | Standard 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.
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)
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
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
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
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
Functional recovery time
Days until return to daily activities and/or work
Measured: up to 6 months post-operative
Recovery from pain
Days until discontinuation of pain medication
Measured: up to 6 months post-operative
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
Range of motion
Range of motion in degrees
Measured: 2, 4 and 6 weeks and 6 months post-operative
thenar atrophies
Presence of thenar atrophies (yes / no)
Measured: 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.
Measured: 2, 4 and 6 weeks and 6 months post-operative
Two-point discrimination
two-point discrimination in millimeter
Measured: 2, 4 and 6 weeks and 6 months post-operative
Grip strength
Grip strength is measured with the Jamar dynamometer
Measured: 2, 4 and 6 weeks and 6 months post-operative
Pinch strength
Pinch strength is measured with the Jamar dynamometer
Measured: 2, 4 and 6 weeks and 6 months post-operative
Pain intensity
Pain measured with the visual analog scale (VAS) from 0-10
Measured: 2, 4 and 6 weeks and 6 months post-operative
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.
- First posted30 May 2025
- Study startMay 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal TunnelStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saskia Kamphuis, Study chair, University Hospital, Basel, Switzerland
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
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06997172
- Acronym / sponsor ID
- 2025-00406; mu25Kamphuis
- Conditions
- Carpal Tunnel
- Keywords
- Percutaneous sonography guided release
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCTR (thread carpal tunnel release) | Experimental | Procedure: TCTR (thread carpal tunnel release)Percutaneous sonography guided release of carpal tunnel |
| Standard of care technique | Active comparator | Procedure: Standard-of-careStandard of care technique (consisting of either the open or endoscopic technique) release of carpal tunnel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged 18 years or older
- Electroneurographically proven carpal tunnel syndrome
- Informed Consent for trial participation
Key exclusion criteria (2 listed)
- Revision surgery
- Inability to give informed consent, whether it be due to an insurmountable language barrier or another reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCTR (thread carpal tunnel release)Percutaneous sonography guided release of carpal tunnel release | Procedure or surgery | TCTR (thread carpal tunnel release) |
| Standard-of-careOpen or endoscopic carpal tunnel release based on patients' and physicians' preferences | Procedure or surgery | Standard of care technique |
Primary outcome
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.
15 secondary outcomes
The objective functional assessment of the BCTQ score
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.
Time frame: 2, 4 and 6 weeks and 6 months post-operative
The subjective symptom severity score of the BCTQ
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Hand-specific health
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Functional recovery time
Time frame: up to 6 months post-operative
Recovery from pain
Time frame: up to 6 months post-operative
Area of the median nerve
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Range of motion
Time frame: 2, 4 and 6 weeks and 6 months post-operative
thenar atrophies
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Strength in the abductor pollicis brevis
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Two-point discrimination
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Grip strength
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Pinch strength
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Pain intensity
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Outcome satisfaction
Time frame: 2, 4 and 6 weeks and 6 months post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saskia Kamphuis study chair
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
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.