Thread-Embedding Acupuncture Versus Electroacupuncture for Mild-to-Moderate Carpal Tunnel Syndrome
24 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
80
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Ho Chi Minh City, Vietnã, 70000
- University Medical Center Ho Chi Minh City - Campus 3
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Thread-Embedding Acupuncture
Participants received thread-embedding acupuncture twice over two weeks, at baseline and week 1, in addition to standard care.
|
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.
|
|
Comparador Ativo: Electroacupuncture
Participants received electroacupuncture once daily, five times per week for two weeks, for a total of 10 sessions, in addition to 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.
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline in Paresthesia Visual Analog Scale Score at Week 4
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline in Paresthesia Visual Analog Scale Score at Week 2
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Colaboradores
Investigadores
- Investigador principal: Minh-Man P Bui, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
21 de outubro de 2024
Conclusão Primária (Real)
26 de maio de 2025
Conclusão do estudo (Real)
26 de maio de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
24 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de agosto de 2026
Primeira postagem (Real)
27 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do Sistema Nervoso
- Ferimentos e Lesões
- Doenças Neuromusculares
- Doenças do Sistema Nervoso Periférico
- Neuropatia Mediana
- Mononeuropatias
- Síndromes de Compressão Nervosa
- Distúrbios Traumáticos Cumulativos
- Entorses e distensões
- Síndrome do túnel carpal
- Administração de Serviços de Saúde
- Qualidade, acesso e avaliação da assistência médica
- Terapêutica
- Qualidade de assistência médica
- Terapias complementares
- Modalidades de fisioterapia
- Indicadores de qualidade, assistência médica
- Reabilitação
- Anestesia e analgesia
- Terapia de estimulação elétrica
- Terapia de modalidade combinada
- Anestesia
- Analgesia
- Terapia de acupuntura
- Estimulação do nervo elétrico transcutâneo
- Padrão de atendimento
- Eletroacupuntura
Outros números de identificação do estudo
- 2583/DHYD-HDDD
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
De-identified individual participant data underlying the results reported in the published article will be available from the corresponding author upon reasonable request.
Prazo de Compartilhamento de IPD
Beginning after publication of the study results, with no predetermined end date.
Critérios de acesso de compartilhamento 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .