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 (MeDe)
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
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:
- Standard surgery - only releasing the carpal tunnel.
- 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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Sebastian Poggio Voormolen, BSc, PhD candidate
- Telefonní číslo: +31 6 46560865
- E-mail: PoggioVoormolenS@maasstadziekenhuis.nl
Studijní místa
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South Holland
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Rotterdam, South Holland, Holandsko, 3079 DZ
- Nábor
- Maasstad ziekenhuis
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Kontakt:
- Niels W.L Schep, MD, PhD
- Telefonní číslo: +31 6 24232542
- E-mail: SchepN@maasstadziekenhuis.nl
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Dílčí vyšetřovatel:
- Sebastian Poggio Voormolen, BSc, PhD candidate
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Dílčí vyšetřovatel:
- Ileen Domela Nieuwenhuis Nyegaard, MD, PhD candidate
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Vrchní vyšetřovatel:
- Niels W.L Schep, MD, PhD
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Rotterdam, South Holland, Holandsko, 3201 GZ
- Nábor
- Spijkenise Medisch Centrum
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Kontakt:
- Niels W.L Schep, MD, PhD
- Telefonní číslo: +31 6 24232542
- E-mail: SchepN@maasstadziekenhuis.nl
-
Dílčí vyšetřovatel:
- Sebastian Poggio Voormolen, BSc, PhD candidate
-
Dílčí vyšetřovatel:
- Ileen Domela Nieuwenhuis Nyegaard, MD, PhD candidate
-
Vrchní vyšetřovatel:
- Niels W.L Schep, MD, PhD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: carpal tunnel release
Control group
|
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.
|
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Jiný: carpal tunnel release combined with Lacertus release
Intervention group
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS)
Časové okno: At twelve months follow-up
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Scores range from 1 to 5. A higher score indicates a more severe level of impairment or discomfort.
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At twelve months follow-up
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pillar pain
Časové okno: From 6 weeks after surgery until 12 months of follow-up
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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
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From 6 weeks after surgery until 12 months of follow-up
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(Return to) work using the QuickDASH work module.
Časové okno: From enrollment until 6 months of follow-up.
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From enrollment until 6 months of follow-up.
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Sensibility
Časové okno: From enrollment until 12 months of follow-up.
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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.
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From enrollment until 12 months of follow-up.
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Tip-pinch strength
Časové okno: From enrollment until 12 months of follow-up
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Tip-to-tip pinch strength of the first and second digit will be measured with a baseline pinch gauge.
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From enrollment until 12 months of follow-up
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Cost-effectiveness of intervention
Časové okno: From enrollment until 12 months of follow-up
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Measured with health care resource utilisation and costs (iMCQ, iPCQ).
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From enrollment until 12 months of follow-up
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Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS)
Časové okno: From enrollment until 12 months of follow-up
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Scores range from 1 to 5. A higher score indicates a more severe level of impairment or discomfort.
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From enrollment until 12 months of follow-up
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Anchor questions
Časové okno: At 12 months follow-up
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Regarding patient satisfaction to analyse minimal clinically important difference (MCID)
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At 12 months follow-up
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Number of participants with residual, persistent en recurrent CTS symptoms
Časové okno: From 6 weeks after surgery until 12 months of follow-up
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From 6 weeks after surgery until 12 months of follow-up
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Number of participants undergoing secondary surgery
Časové okno: From 6 weeks until 12 months of follow-up.
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This includes, but is not limited to, nerve decompression, internal or external neurolysis, and flap reconstruction in the ipsilateral arm.
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From 6 weeks until 12 months of follow-up.
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Number of participants that experienced complications or adverse events
Časové okno: From enrollment until 12 months of follow-up.
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Such as infection, seroma, and tendon and neurovascular damage.
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From enrollment until 12 months of follow-up.
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5-level EuroQol (EQ-5D-5L): Quality of life
Časové okno: Will be assessed at baseline and at 12 months of follow-up.
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Will be assessed using the 5-level EuroQol (EQ-5D-5L) questionnaire.
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Will be assessed at baseline and at 12 months of follow-up.
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Physical examination
Časové okno: From enrollment until 12 months of follow-up.
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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.
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Exploratory ultrasound
Časové okno: Will be assessed at baseline and 3 months.
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Changes in median nerve cross-sectional diameter (mm) to evaluate postoperative changes in nerve size over time, measured by nerve ultrasound.
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Will be assessed at baseline and 3 months.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Patient Demographics
Časové okno: At baseline
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Age, sex, labour (blue versus white collar), hand dominance and medical history regarding comorbidities and hand-specific conditions
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At baseline
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NL-OMON57619
- NL-005174 (Identifikátor registru: CCMO: Research with human participants)
- NL87289.100.2 (Jiný identifikátor: ICTRP)
- R24.082 (Jiný identifikátor: MEC-U)
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