MeDe Study: Comparing Median Nerve Decompression at the Carpal Tunnel Alone Versus Median Nerve Decompression at Both the Carpal Tunnel and Lacertus Fibrosis in Adults With Carpal Tunnel Syndrome

Official title

MeDe Study: A Randomized Controlled Trial Comparing Median Nerve Decompression at the Carpal Tunnel Alone Versus Median Nerve Decompression at Both the Carpal Tunnel and Lacertus Fibrosis in Adults With Carpal Tunnel Syndrome

Overview

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.

Detailed description

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.

Interventions

• Procedure Carpal tunnel release
  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.
• Procedure Combined carpal tunnel and lacertus release
  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 m

Primary outcome measures

• Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS) [Time frame: At twelve months follow-up]

Secondary outcome measures (12)

• Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS) [Time frame: From enrollment until 12 months of follow-up]
• Anchor questions [Time frame: At 12 months follow-up]
• Number of participants with residual, persistent en recurrent CTS symptoms [Time frame: From 6 weeks after surgery until 12 months of follow-up]
• Pillar pain [Time frame: From 6 weeks after surgery until 12 months of follow-up]
• Number of participants undergoing secondary surgery [Time frame: From 6 weeks until 12 months of follow-up.]
• Number of participants that experienced complications or adverse events [Time frame: From enrollment until 12 months of follow-up.]
• (Return to) work using the QuickDASH work module. [Time frame: From enrollment until 6 months of follow-up.]
• Sensibility [Time frame: From enrollment until 12 months of follow-up.]
• Tip-pinch strength [Time frame: From enrollment until 12 months of follow-up]
• Cost-effectiveness of intervention [Time frame: From enrollment until 12 months of follow-up]
• 5-level EuroQol (EQ-5D-5L): Quality of life [Time frame: Will be assessed at baseline and at 12 months of follow-up.]
• Physical examination [Time frame: From enrollment until 12 months of follow-up.]

Eligibility criteria

Inclusion criteria

• Patients being at least 18 years or older
• CTS confirmed by EMG or nerve ultrasound
• Patient opts for surgical treatment

Exclusion criteria

• 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)
• Malunion of the distal radius
• Impaired hand function
• Pregnancy
• Inability to complete study forms due to insufficient comprehension of the Dutch language

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Netherlands · 2 centers

• Maasstad Ziekenhuis — Rotterdam
• Spijkenise Medisch Centrum — Rotterdam

Identifiers

NCT: NCT07594821 · NL-OMON57619 · NL-005174 · NL87289.100.2 · R24.082

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗