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| ID | Type | Description | Link |
|---|---|---|---|
| NL-005174 | Registry Identifier | CCMO: Research with human participants | |
| NL87289.100.2 | Other Identifier | ICTRP | |
| R24.082 | Other Identifier | MEC-U |
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Carpal tunnel syndrome (CTS) is a condition that can cause pain, numbness, or tingling in the hand and wrist. The most common surgery for CTS is called carpal tunnel release, which aims to relieve pressure on the main nerve in the wrist.
However, after this surgery, some patients (up to 4 out of 10) still have symptoms, and about 1 in 8 may need another surgery. One reason symptoms can continue is that the nerve may also be compressed higher up in the arm, near a ligament called the Lacertus fibrosus. Releasing this area might help, but it is often not checked or treated during the first surgery because current tests (like physical exams, nerve studies, and ultrasounds) cannot reliably detect it.
This study is comparing two approaches for people with CTS:
The goal is to see which surgery helps patients feel better and have fewer symptoms in the hand and wrist after treatment.
Carpal tunnel release is the most commonly performed surgical procedure in patients diagnosed with carpal tunnel syndrome (CTS). Nevertheless, up to 43% of patients experience residual symptoms, necessitating secondary surgical interventions in approximately one out of eight carpal tunnel releases.
These residual symptoms may be attributable to proximal median nerve compression (PMNC), which can potentially be alleviated by performing a Lacertus release. However, diagnosing PMNC poses a challenge, as standard diagnostic tools like physical examination, electromyography (EMG) and ultrasound lack the specificity to distinguish between CTS and PMNC. Consequently, PMNC often goes undetected and untreated during initial evaluations.
This randomised trial compares patient reported outcomes following median nerve decompression at the carpal tunnel alone versus median nerve decompression at both the carpal tunnel and the Lacertus fibrosus in individuals with CTS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carpal tunnel release | Other | Control group |
|
| carpal tunnel release combined with Lacertus release | Other | Intervention group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carpal tunnel release | Procedure | Carpal tunnel release is a surgical procedure to treat carpal tunnel syndrome by cutting the ligament (transverse carpal ligament) covering the wrist's carpal tunnel. This action relieves pressure on the median nerve, alleviating pain, numbness, and weakness in the hand. It is usually an outpatient procedure done under local anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS) | Scores range from 1 to 5. A higher score indicates a more severe level of impairment or discomfort. | At twelve months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS) | Scores range from 1 to 5. A higher score indicates a more severe level of impairment or discomfort. | From enrollment until 12 months of follow-up |
| Anchor questions |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Demographics | Age, sex, labour (blue versus white collar), hand dominance and medical history regarding comorbidities and hand-specific conditions | At baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Poggio Voormolen, BSc, PhD candidate | Contact | +31 6 46560865 | PoggioVoormolenS@maasstadziekenhuis.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maasstad Ziekenhuis | Recruiting | Rotterdam | South Holland | 3079 DZ | Netherlands |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Study protocol version 3.2 | Aug 6, 2025 |
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| Combined carpal tunnel and lacertus release | Procedure | A transverse incision is made on the forearm's volar (anterior) aspect, approximately 3cm distal of the elbow crease. This incision is placed over the palpable brachioradialis and biceps tendon. The subcutaneous tissue is dissected to expose the fascia overlying the flexor pronator muscles. The brachial fascia is identified and incised to reveal the underlying Lacertus fibrosus (also known as the bicipital aponeurosis). The Lacertus fibrosus is a tendinous band extending from the biceps tendon medially across the forearm. Care is taken to avoid injury to the underlying structures, particularly the median nerve, which lies deep and slightly medial to the Lacertus fibrosus. The Lacertus fibrosus is incised transversely. The surgeon ensures that the median nerve is fully decompressed and that there are no remaining constrictive bands. It is usually an outpatient procedure done under local anesthesia. |
|
Regarding patient satisfaction to analyse minimal clinically important difference (MCID)
| At 12 months follow-up |
| Number of participants with residual, persistent en recurrent CTS symptoms | From 6 weeks after surgery until 12 months of follow-up |
| Pillar pain | The presence of tenderness or pain in the thenar or hypothenar area around the hook of the hamate and the unciform process of the trapezium | From 6 weeks after surgery until 12 months of follow-up |
| Number of participants undergoing secondary surgery | This includes, but is not limited to, nerve decompression, internal or external neurolysis, and flap reconstruction in the ipsilateral arm. | From 6 weeks until 12 months of follow-up. |
| Number of participants that experienced complications or adverse events | Such as infection, seroma, and tendon and neurovascular damage. | From enrollment until 12 months of follow-up. |
| (Return to) work using the QuickDASH work module. | From enrollment until 6 months of follow-up. |
| Sensibility | Monofilament test on the tuft of the 3rd digit and the proximal thenar. The tuft of the 5th digit and the distal thenar will be measured and used as a reference. | From enrollment until 12 months of follow-up. |
| Tip-pinch strength | Tip-to-tip pinch strength of the first and second digit will be measured with a baseline pinch gauge. | From enrollment until 12 months of follow-up |
| Cost-effectiveness of intervention | Measured with health care resource utilisation and costs (iMCQ, iPCQ). | From enrollment until 12 months of follow-up |
| 5-level EuroQol (EQ-5D-5L): Quality of life | Will be assessed using the 5-level EuroQol (EQ-5D-5L) questionnaire. | Will be assessed at baseline and at 12 months of follow-up. |
| Physical examination | OK-sign, FLP and FDP2 strength separately (compared to contralateral hand). Scratch collapse test over the carpal tunnel and Lacertus fibrosis (positive or negative). Phalen and Tinel test (positive or negative). | From enrollment until 12 months of follow-up. |
| Exploratory ultrasound | Changes in median nerve cross-sectional diameter (mm) to evaluate postoperative changes in nerve size over time, measured by nerve ultrasound. | Will be assessed at baseline and 3 months. |
| Spijkenise Medisch Centrum | Recruiting | Rotterdam | South Holland | 3201 GZ | Netherlands |
|
| May 8, 2026 |
| Prot_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study protocol version 3.3 | May 27, 2026 | Jun 23, 2026 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
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