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

24 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Zespół cieśni nadgarstka (CTS)

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

Faza

Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Dorosły
Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Główny cel: Leczenie
Przydział: Randomizowane
Model interwencyjny: Przydział równoległy
Maskowanie: Pojedynczy

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm	Interwencja / Leczenie
Eksperymentalny: Thread-Embedding Acupuncture Participants received thread-embedding acupuncture twice over two weeks, at baseline and week 1, in addition to standard care.	Procedura: 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. Inny: 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.
Aktywny komparator: Electroacupuncture Participants received electroacupuncture once daily, five times per week for two weeks, for a total of 10 sessions, in addition to standard care.	Inny: 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. Procedura: 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.

Grupa uczestników / Arm

Interwencja / Leczenie

Eksperymentalny: Thread-Embedding Acupuncture

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

Procedura: 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.

Inny: 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.

Aktywny komparator: Electroacupuncture

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

Inny: Standard Care

Procedura: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Change From Baseline in Paresthesia Visual Analog Scale Score at Week 4 Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Change From Baseline in Paresthesia Visual Analog Scale Score at Week 2 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Współpracownicy

Hoang Binh Trading Services Co., Ltd

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

21 października 2024

Zakończenie podstawowe (Rzeczywisty)

26 maja 2025

Ukończenie studiów (Rzeczywisty)

26 maja 2025

Daty rejestracji na studia

Pierwszy przesłany

24 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

27 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

27 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

24 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

2583/DHYD-HDDD

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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