Thread-Embedding Acupuncture Versus Electroacupuncture for Mild-to-Moderate Carpal Tunnel Syndrome
24 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
80
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ho Chi Minh City, Vietnam, 70000
- University Medical Center Ho Chi Minh City - Campus 3
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Thread-Embedding Acupuncture
Participants received thread-embedding acupuncture twice over two weeks, at baseline and week 1, in addition to standard care.
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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.
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.
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Actieve vergelijker: Electroacupuncture
Participants received electroacupuncture once daily, five times per week for two weeks, for a total of 10 sessions, in addition to standard care.
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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.
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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change From Baseline in Paresthesia Visual Analog Scale Score at Week 4
Tijdsspanne: Baseline to Week 4
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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.
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Baseline to Week 4
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change From Baseline in Paresthesia Visual Analog Scale Score at Week 2
Tijdsspanne: Baseline to Week 2
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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.
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Baseline to Week 2
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Change From Baseline in Pain Visual Analog Scale Score
Tijdsspanne: Baseline to Week 2 and Week 4
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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.
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Baseline to Week 2 and Week 4
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Change From Baseline in Boston Carpal Tunnel Questionnaire Scores
Tijdsspanne: Baseline to Week 2 and Week 4
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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.
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Baseline to Week 2 and Week 4
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Weekly Paracetamol Consumption
Tijdsspanne: Weekly during the 4-week study period
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Rescue paracetamol use was recorded as the number of 500-mg tablets consumed per week.
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Weekly during the 4-week study period
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Adverse Events
Tijdsspanne: From baseline through Week 4
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Adverse events occurring during the study were monitored and recorded, including events such as ecchymosis and localized pain associated with the acupuncture procedures.
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From baseline through Week 4
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Minh-Man P Bui, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
21 oktober 2024
Primaire voltooiing (Werkelijk)
26 mei 2025
Studie voltooiing (Werkelijk)
26 mei 2025
Studieregistratiedata
Eerst ingediend
24 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
24 augustus 2026
Eerst geplaatst (Werkelijk)
27 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
24 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het zenuwstelsel
- Wonden en verwondingen
- Neuromusculaire aandoeningen
- Ziekten van het perifere zenuwstelsel
- Mediane neuropathie
- Mononeuropathieën
- Zenuwcompressiesyndromen
- Cumulatieve traumastoornissen
- Verstuikingen en verrekkingen
- Carpaal tunnel syndroom
- Health Services Administration
- Kwaliteit, toegang en evaluatie van de gezondheidszorg
- Therapeutica
- Kwaliteit van de gezondheidszorg
- Complementaire therapieën
- Modaliteiten fysiotherapie
- Kwaliteitsindicatoren, gezondheidszorg
- Revalidatie
- Anesthesie en analgesie
- Elektrische stimulatietherapie
- Gecombineerde modaliteitstherapie
- Anesthesie
- Analgetie
- Acupunctuurtherapie
- Transcutane elektrische zenuwstimulatie
- Zorgstandaard
- Elektroacupunctuur
Andere studie-ID-nummers
- 2583/DHYD-HDDD
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
De-identified individual participant data underlying the results reported in the published article will be available from the corresponding author upon reasonable request.
IPD-tijdsbestek voor delen
Beginning after publication of the study results, with no predetermined end date.
IPD-toegangscriteria voor delen
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .