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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 2 центра

• Maasstad Ziekenhuis — Rotterdam
• Spijkenise Medisch Centrum — Rotterdam

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗