Thread-Embedding Acupuncture Versus Electroacupuncture for Mild-to-Moderate Carpal Tunnel Syndrome
24 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
80
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ho Chi Minh City, Vietnam, 70000
- University Medical Center Ho Chi Minh City - Campus 3
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Paresthesia Visual Analog Scale Score at Week 4
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Paresthesia Visual Analog Scale Score at Week 2
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Investigador principal: Minh-Man P Bui, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
21 de octubre de 2024
Finalización primaria (Actual)
26 de mayo de 2025
Finalización del estudio (Actual)
26 de mayo de 2025
Fechas de registro del estudio
Enviado por primera vez
24 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de agosto de 2026
Publicado por primera vez (Actual)
27 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Enfermedades Neuromusculares
- Enfermedades del Sistema Nervioso Periférico
- Neuropatía mediana
- Mononeuropatías
- Síndromes de compresión nerviosa
- Trastornos Traumáticos Acumulativos
- Torceduras y esguinces
- Síndrome del túnel carpiano
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Terapéutica
- Calidad de la atención médica
- Terapias complementarias
- Modalidades de fisioterapia
- Indicadores de calidad, atención médica
- Rehabilitación
- Anestesia y analgesia
- Terapia de estimulación eléctrica
- Terapia de modalidad combinada
- Anestesia
- Analgesia
- Terapia de acupuntura
- Estimulación del nervio eléctrico transcutáneo
- Estándar de cuidado
- Electroacupuntura
Otros números de identificación del estudio
- 2583/DHYD-HDDD
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified individual participant data underlying the results reported in the published article will be available from the corresponding author upon reasonable request.
Marco de tiempo para compartir IPD
Beginning after publication of the study results, with no predetermined end date.
Criterios de acceso compartido de 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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