Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Thread-Embedding Acupuncture Versus Electroacupuncture for Mild-to-Moderate Carpal Tunnel Syndrome

24. srpna 2026 aktualizováno: Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City

Thread-Embedding Acupuncture Versus Electroacupuncture for Mild-to-Moderate Carpal Tunnel Syndrome: An Assessor-Blinded Randomized Controlled Trial

This study compared thread-embedding acupuncture with electroacupuncture for adults with mild-to-moderate carpal tunnel syndrome confirmed by electrodiagnosis. Eighty participants were randomly assigned in a 1:1 ratio to receive either thread-embedding acupuncture or electroacupuncture. Both groups also received standard care, including lifestyle modification, nocturnal wrist splinting, nerve and tendon gliding exercises, and paracetamol as needed. Thread-embedding acupuncture was administered twice over two weeks, whereas electroacupuncture was administered 10 times over the same period. Participants were assessed at baseline, week 2, and week 4. The primary outcome was the change in paresthesia intensity from baseline to week 4, measured using a 100-mm visual analog scale. Secondary outcomes included pain intensity, symptom severity, functional status, paracetamol use, and adverse events.

Přehled studie

Postavení

Dokončeno

Podmínky

Syndrom karpálního tunelu (CTS)

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

Fáze

Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Vietnam
- - Ho Chi Minh City, Vietnam, 70000
    - University Medical Center Ho Chi Minh City - Campus 3

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

Dospělý
Starší dospělý

Přijímá zdravé dobrovolníky

Popis

Inclusion Criteria:

Age 18 years or older.
Primary diagnosis of carpal tunnel syndrome with pain and paresthesia, confirmed by electrodiagnosis and classified as mild or moderate severity.
Unilateral carpal tunnel syndrome involving either the right or left hand.
Voluntary written informed consent to participate in the study.

Exclusion Criteria:

Structural wrist damage due to previous surgery or trauma.
History of carpal tunnel syndrome surgery.
Carpal tunnel syndrome with an indication for surgical treatment.
Concomitant cervical radiculopathy, brachial plexopathy, proximal median neuropathy, other upper-limb neuropathies, or polyneuropathy confirmed by electrodiagnosis.
Systemic inflammatory diseases, including rheumatoid arthritis, gout, ankylosing spondylitis, or psoriatic arthritis.
Hypothyroidism.
Unstable or untreated severe health conditions, including end-stage renal failure, severe hepatic failure, or NYHA class IV heart failure.
Use of anti-inflammatory medications within two weeks before enrollment.
Alcohol or substance abuse.
Pregnancy or lactation.
History of allergy, anaphylaxis, or contraindications to thread-embedding acupuncture or electroacupuncture, including emergency conditions, cachexia, local skin infections or dermatological diseases at acupoint sites, or allergy to absorbable sutures.
Current treatment with anticoagulant drugs or diagnosed coagulation disorders.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Primární účel: Léčba
Přidělení: Randomizované
Intervenční model: Paralelní přiřazení
Maskování: Singl

Počet zbraní

Zbraně a zásahy

Skupina účastníků / Arm	Intervence / Léčba
Experimentální: Thread-Embedding Acupuncture Participants received thread-embedding acupuncture twice over two weeks, at baseline and week 1, in addition to standard care.	Postup: Thread-Embedding Acupuncture Thread-embedding acupuncture was administered twice over two weeks, at baseline and week 1. Sterile polydioxanone thread-embedding needles were inserted at PC4, PC6, PC7, PC8, LI4, LI5, LU10, LU6, HT7, and TE5. The device consisted of a sterile 31-G stainless-steel cannula with a 30-mm needle shaft and a 30-mm polydioxanone thread folded in half, corresponding to an embedded thread length of approximately 15 mm. The thread was placed within the muscle layer and left in situ after withdrawal of the needle. Jiný: Standard Care Both treatment groups received standard care throughout the four-week study period, including lifestyle modification to avoid wrist flexion and strain, nocturnal wrist splinting, daily nerve and tendon gliding exercises, and paracetamol 500 mg as needed for intolerable pain with a minimum four-hour interval between doses.
Aktivní komparátor: Electroacupuncture Participants received electroacupuncture once daily, five times per week for two weeks, for a total of 10 sessions, in addition to standard care.	Jiný: Standard Care Both treatment groups received standard care throughout the four-week study period, including lifestyle modification to avoid wrist flexion and strain, nocturnal wrist splinting, daily nerve and tendon gliding exercises, and paracetamol 500 mg as needed for intolerable pain with a minimum four-hour interval between doses. Postup: Electroacupuncture Electroacupuncture was administered once daily, five times per week for two weeks, for a total of 10 sessions. Sterile disposable needles were inserted at PC4, PC6, PC7, PC8, LI4, LI5, LU10, LU6, HT7, and TE5. Continuous biphasic rectangular pulses with alternating frequencies of 2/100 Hz every 3 seconds and a pulse width of 0.2 ms were delivered for 20 minutes. Stimulation intensity was adjusted within 2-5 mA according to participant tolerance.

Skupina účastníků / Arm

Intervence / Léčba

Experimentální: Thread-Embedding Acupuncture

Participants received thread-embedding acupuncture twice over two weeks, at baseline and week 1, in addition to standard care.

Postup: Thread-Embedding Acupuncture

Thread-embedding acupuncture was administered twice over two weeks, at baseline and week 1. Sterile polydioxanone thread-embedding needles were inserted at PC4, PC6, PC7, PC8, LI4, LI5, LU10, LU6, HT7, and TE5. The device consisted of a sterile 31-G stainless-steel cannula with a 30-mm needle shaft and a 30-mm polydioxanone thread folded in half, corresponding to an embedded thread length of approximately 15 mm. The thread was placed within the muscle layer and left in situ after withdrawal of the needle.

Jiný: Standard Care

Both treatment groups received standard care throughout the four-week study period, including lifestyle modification to avoid wrist flexion and strain, nocturnal wrist splinting, daily nerve and tendon gliding exercises, and paracetamol 500 mg as needed for intolerable pain with a minimum four-hour interval between doses.

Aktivní komparátor: Electroacupuncture

Participants received electroacupuncture once daily, five times per week for two weeks, for a total of 10 sessions, in addition to standard care.

Jiný: Standard Care

Postup: Electroacupuncture

Electroacupuncture was administered once daily, five times per week for two weeks, for a total of 10 sessions. Sterile disposable needles were inserted at PC4, PC6, PC7, PC8, LI4, LI5, LU10, LU6, HT7, and TE5. Continuous biphasic rectangular pulses with alternating frequencies of 2/100 Hz every 3 seconds and a pulse width of 0.2 ms were delivered for 20 minutes. Stimulation intensity was adjusted within 2-5 mA according to participant tolerance.

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Change From Baseline in Paresthesia Visual Analog Scale Score at Week 4 Časové okno: Baseline to Week 4	Paresthesia intensity was measured using a self-reported 100-mm visual analog scale ranging from 0 mm, representing no symptom, to 100 mm, representing the worst imaginable symptom. The outcome was the change in paresthesia-VAS score from baseline to week 4.	Baseline to Week 4

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Change From Baseline in Paresthesia Visual Analog Scale Score at Week 2 Časové okno: Baseline to Week 2	Paresthesia intensity was measured using a self-reported 100-mm visual analog scale ranging from 0 mm, representing no symptom, to 100 mm, representing the worst imaginable symptom. The outcome was the change in paresthesia-VAS score from baseline to week 2.	Baseline to Week 2
Change From Baseline in Pain Visual Analog Scale Score Časové okno: Baseline to Week 2 and Week 4	Pain intensity was measured using a 100-mm visual analog scale ranging from 0 mm, representing no pain, to 100 mm, representing the worst imaginable pain. The outcome was the change in pain-VAS score from baseline.	Baseline to Week 2 and Week 4
Change From Baseline in Boston Carpal Tunnel Questionnaire Scores Časové okno: Baseline to Week 2 and Week 4	The Boston Carpal Tunnel Questionnaire consists of the Symptom Severity Scale (SSS) and Functional Status Scale (FSS). The SSS includes 11 items scored from 1 to 5, with a total score ranging from 11 to 55. The FSS includes 8 items scored from 1 to 5, with a total score ranging from 8 to 40. The overall BCTQ score was calculated as the sum of the SSS and FSS scores, ranging from 19 to 95. Higher scores indicate greater symptom severity and functional impairment.	Baseline to Week 2 and Week 4
Weekly Paracetamol Consumption Časové okno: Weekly during the 4-week study period	Rescue paracetamol use was recorded as the number of 500-mg tablets consumed per week.	Weekly during the 4-week study period
Adverse Events Časové okno: From baseline through Week 4	Adverse events occurring during the study were monitored and recorded, including events such as ecchymosis and localized pain associated with the acupuncture procedures.	From baseline through Week 4

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Medicine and Pharmacy at Ho Chi Minh City

Spolupracovníci

Hoang Binh Trading Services Co., Ltd

Vyšetřovatelé

Vrchní vyšetřovatel: Minh-Man P Bui, PhD, University of Medicine and Pharmacy at Ho Chi Minh City

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

21. října 2024

Primární dokončení (Aktuální)

26. května 2025

Dokončení studie (Aktuální)

26. května 2025

Termíny zápisu do studia

První předloženo

24. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

24. srpna 2026

První zveřejněno (Aktuální)

27. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

27. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

24. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

2583/DHYD-HDDD

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

De-identified individual participant data underlying the results reported in the published article will be available from the corresponding author upon reasonable request.

Časový rámec sdílení IPD

Beginning after publication of the study results, with no predetermined end date.

Kritéria přístupu pro sdílení IPD

De-identified individual participant data will be available to qualified researchers upon reasonable request to the corresponding author. Requests should include the purpose of the proposed analysis and will be considered by the study investigators, subject to applicable ethical and institutional requirements.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Studuje produkt zařízení regulovaný americkým úřadem FDA

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Thread-Embedding Acupuncture Versus Electroacupuncture for Mild-to-Moderate Carpal Tunnel Syndrome