Effectiveness of PErcutaneous Ultrasound-guided Carpal Tunnel Release: a Non-inferiority Study With Surgery as Comparator (EPEC)
Effectiveness of PErcutaneous Ultrasound-guided Carpal Tunnel Release: a Non-inferiority Study With Surgery as Comparator (Projet)
Carpal tunnel syndrome is a common condition caused by compression of the median nerve. Tingling in the first three or four fingers, usually at night or upon waking, is the most frequent symptom. Reduced sensation in the fingers and clumsiness can also occur, and in severe cases, there may even be weakness in thumb abduction with thenar muscle wasting. Carpal tunnel syndrome (CTS) is the most commonly diagnosed nerve compression syndrome. The annual incidence of diagnosis varies depending on the study and the country. It's estimated at 3.8 per thousand in the general population, 1 to 2 per thousand in men, 4 to 5 per thousand in women, with a peak between ages 40 and 60.
Medical treatment combines removing a microtraumatic factor, immobilization with a brace, and giving 1 to 2 cortisone injections into the carpal tunnel. The results are good in purely sensory cases. If it doesn't work, things get worse despite treatment, or in severe cases from the start (severe sensory problems, loss of strength, muscle wasting), surgery is recommended.
Several teams have recently demonstrated the benefits of using a minimally invasive ultrasound-guided surgical technique to perform flexor retinaculum sectioning under ultrasound guidance. This technique offers increased safety thanks to continuous ultrasound monitoring and the visualization of median nerve variants. Rojo et al. compared ultrasound surgery with a 1 mm incision to mini-open surgery with a 20 mm incision in 128 patients. This study suggests that a minimally invasive approach could allow for faster functional pain recovery compared to conventional surgery.
This project is based on the hypothesis that the proposed ultrasound-guided percutaneous release technique has an efficacy and tolerability profile suitable for widespread use in the indication of carpal tunnel syndrome resistant to conservative treatment, and that it can therefore reduce the need for conventional surgery in this indication.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Paris, Frankreich, 75010
- Hôpital Lariboisière
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Patient, male or female, over 18 years of age
- Patient with clinical carpal tunnel syndrome
- Patient with unilateral or bilateral carpal tunnel syndrome. In the case of bilateral involvement, the more symptomatic hand (with the highest Boston score) will be included, with the patient agreeing that the second hand will not be operated on within one year.
- Patient with carpal tunnel syndrome confirmed by an EMG less than 6 months old
- Patient with carpal tunnel syndrome without motor or sensory deficits
- Patient with carpal tunnel syndrome resistant to conservative treatment, including at least one corticosteroid injection
- Patient agreeing to undergo surgery
- Patient affiliated with or covered by a social security plan
- Patient who has been informed and has signed a free and informed written consent.
Exclusion Criteria:
- Patient with another condition of the hand or wrist (Dupuytren's disease, inflammatory rheumatism, symptomatic osteoarthritis)
- Patient with a history of previous hand or wrist surgery requiring treatment
- Neurological sequelae of the hand
- Patient with non-medicinal hypocoagulation or vitamin K antagonist overdose
- Patient with a known allergy to lidocaine
- Patient with an unhealed palmo-digital wound
- Patient with a superficial or deep palmo-digital infection or inflammation
- Patient who has received a cortisone injection in the hand or wrist within the last month. - Patient with type 1 diabetes or poorly controlled diabetes (HbA1c >7.5% for less than 3 months)
- Patient with cognitive impairment deemed incompatible with the research by the investigator
- Patient with a language barrier preventing a reliable assessment
- Patient participating in another clinical trial
- Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant, breastfeeding, or postpartum woman
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Patient undergoing percutaneous ultrasound-guided carpal tunnel release procedure.
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The aim of this study is to compare the conventional surgery to the percutaneous ultrasound-guided carpal tunnel release procedure.
One group is doing the conventional surgery and the other the procédure to evaluate.
EVA, Boston and Quick Dash questionnaires : all study visits
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Aktiver Komparator: Patient undergoing conventional surgery.
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The aim of this study is to compare the conventional surgery to the percutaneous ultrasound-guided carpal tunnel release procedure.
One group is doing the conventional surgery and the other the procédure to evaluate.
EVA, Boston and Quick Dash questionnaires : all study visits
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Severity of symptoms" subscore of the Boston Questionnaire
Zeitfenster: 3 months after surgery
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The "Severity of symptoms" subscore of the Boston Questionnaire, specific to carpal tunnel syndrome, 3 months post-intervention, assessed by the clinical research associate, blinded to the procedure performed. Eleven questions with a score between 1 and 5 for each items. The final score is between 11 (no symptoms) and 55 (very high severity). |
3 months after surgery
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Nervensystems
- Wunden und Verletzungen
- Neuromuskuläre Erkrankungen
- Erkrankungen des peripheren Nervensystems
- Mediane Neuropathie
- Mononeuropathien
- Nervenkompressionssyndrome
- Kumulative Traumastörungen
- Verstauchungen und Zerrungen
- Karpaltunnelsyndrom
- Qualität, Zugang und Bewertung im Gesundheitswesen
- Untersuchungstechniken
- Epidemiologische Methoden
- Datenerfassung
- Gesundheitsbewertungsmechanismen
- Qualität der Gesundheitsversorgung
- Öffentliche Gesundheit
- Umwelt und öffentliche Gesundheit
- Umfragen und Fragebögen
Andere Studien-ID-Nummern
- 2020-A00191-38
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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