About this trial
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:
1. Standard surgery - only releasing the carpal tunnel. 2. Extended surgery - releasing both the carpal tunnel and the Lacertus fibrosus.
The goal is to see which surgery helps patients feel better and have fewer symptoms in the hand and wrist after treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients being at least 18 years or older
CTS confirmed by EMG or nerve ultrasound
Patient opts for surgical treatment
Disqualifiers
Previous surgical decompression of the median nerve at the ipsilateral wrist or forearm
Severe thenar atrophy: Examination of the thenar is based on clinical observation. The presence of thenar muscle atrophy is scored as none, mild, or severe.
Simultaneous nerve decompression in the ipsilateral arm (e.g. cubital tunnel, Guyon and radial nerve release.
Neurological disorders affecting peripheral nerves (e.g. spinal cord compression or injury, muscular dystrophy, dystonia, ALS)
Trial design
Parallel
Treatments tested in this trial
Carpal tunnel release
Procedure/SurgeryCarpal 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.
Combined carpal tunnel and lacertus release
Procedure/SurgeryA 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Anchor questions
Regarding patient satisfaction to analyse minimal clinically important difference (MCID)
Number of participants with residual, persistent en recurrent CTS symptoms
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
Other outcomes
Patient Demographics
Age, sex, labour (blue versus white collar), hand dominance and medical history regarding comorbidities and hand-specific conditions
Sponsors and contacts
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