Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCTR (thread carpal tunnel release) | Experimental | Percutaneous sonography guided release of carpal tunnel |
|
| Standard of care technique | Active Comparator | Standard of care technique (consisting of either the open or endoscopic technique) release of carpal tunnel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCTR (thread carpal tunnel release) | Procedure | Percutaneous sonography guided release of carpal tunnel release |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saskia Kamphuis, MD | Contact | +41 61 556 54 82 | Saskia.Kamphuis@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Saskia Kamphuis | University Hospital, Basel, Switzerland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4031 | Switzerland |
Not provided
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard-of-care | Procedure | Open or endoscopic carpal tunnel release based on patients' and physicians' preferences |
|
| 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. | 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. | 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. | 2, 4 and 6 weeks and 6 months post-operative |
| Functional recovery time | Days until return to daily activities and/or work | up to 6 months post-operative |
| Recovery from pain | Days until discontinuation of pain medication | up to 6 months post-operative |
| Area of the median nerve | Cross sectional area of the median nerve (cm2) is investigatad by sonographic | 2, 4 and 6 weeks and 6 months post-operative |
| Range of motion | Range of motion in degrees | 2, 4 and 6 weeks and 6 months post-operative |
| thenar atrophies | Presence of thenar atrophies (yes / no) | 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. | 2, 4 and 6 weeks and 6 months post-operative |
| Two-point discrimination | two-point discrimination in millimeter | 2, 4 and 6 weeks and 6 months post-operative |
| Grip strength | Grip strength is measured with the Jamar dynamometer | 2, 4 and 6 weeks and 6 months post-operative |
| Pinch strength | Pinch strength is measured with the Jamar dynamometer | 2, 4 and 6 weeks and 6 months post-operative |
| Pain intensity | Pain measured with the visual analog scale (VAS) from 0-10 | 2, 4 and 6 weeks and 6 months post-operative |
| Outcome satisfaction | Patient satisfaction measured with the VAS from 0-10 | 2, 4 and 6 weeks and 6 months post-operative |