Thread-Embedding Acupuncture Versus Electroacupuncture for Mild-to-Moderate Carpal Tunnel Syndrome
24. august 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ho Chi Minh City, Vietnam, 70000
- University Medical Center Ho Chi Minh City - Campus 3
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Aktiv 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.
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change From Baseline in Paresthesia Visual Analog Scale Score at Week 4
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change From Baseline in Paresthesia Visual Analog Scale Score at Week 2
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Minh-Man P Bui, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
21. oktober 2024
Primær fullføring (Faktiske)
26. mai 2025
Studiet fullført (Faktiske)
26. mai 2025
Datoer for studieregistrering
Først innsendt
24. august 2026
Først innsendt som oppfylte QC-kriteriene
24. august 2026
Først lagt ut (Faktiske)
27. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i nervesystemet
- Sår og skader
- Nevromuskulære sykdommer
- Sykdommer i det perifere nervesystemet
- Median nevropati
- Mononeuropatier
- Nervekompresjonssyndromer
- Kumulative traumelidelser
- Forstuinger og stammer
- Karpaltunellsyndrom
- Health Services Administration
- Helsevesenets kvalitet, tilgang og evaluering
- Terapeutikk
- Kvalitet på helsehjelpen
- Komplementære terapier
- Fysioterapi -modaliteter
- Kvalitetsindikatorer, helsehjelp
- Rehabilitering
- Anestesi og smertestillende
- Elektrisk stimuleringsbehandling
- Kombinert modalitetsterapi
- Anestesi
- Analgesi
- Akupunkturbehandling
- Transkutan elektrisk nervestimulering
- Standard for omsorg
- Elektroakupunktur
Andre studie-ID-numre
- 2583/DHYD-HDDD
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data underlying the results reported in the published article will be available from the corresponding author upon reasonable request.
IPD-delingstidsramme
Beginning after publication of the study results, with no predetermined end date.
Tilgangskriterier for IPD-deling
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.
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