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

24 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Sindrome del tunnel carpale (STC)

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

Fase

Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto
Adulto più anziano

Accetta volontari sani

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm Gruppo di partecipanti / Arm Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.	Intervento / Trattamento Intervento / Trattamento Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Sperimentale: 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. Altro: 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.
Comparatore attivo: Electroacupuncture Participants received electroacupuncture once daily, five times per week for two weeks, for a total of 10 sessions, in addition to standard care.	Altro: 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.

Gruppo di partecipanti / Arm

Intervento / Trattamento

Sperimentale: 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.

Altro: 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.

Comparatore attivo: Electroacupuncture

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

Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Change From Baseline in Paresthesia Visual Analog Scale Score at Week 4 Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Change From Baseline in Paresthesia Visual Analog Scale Score at Week 2 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Collaboratori

Hoang Binh Trading Services Co., Ltd

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

21 ottobre 2024

Completamento primario (Effettivo)

26 maggio 2025

Completamento dello studio (Effettivo)

26 maggio 2025

Date di iscrizione allo studio

Primo inviato

24 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 agosto 2026

Primo Inserito (Effettivo)

27 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

2583/DHYD-HDDD

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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