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- Essai clinique NCT01966250
Electroacupuncture as a Complement to Usual Care for Patients With Non-acute Pain After Back Surgery
Electroacupuncture as a Complement to Usual Care for Patients With Non-acute Pain After Back Surgery: a Study Protocol for a Pilot Randomized Controlled Trial
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Gyeongsangnamdo
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Yangsan, Gyeongsangnamdo, Corée, République de, 626-770
- Pusan National University Korean Medicine Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients whose low back pain persisted or recurred after back surgery with or without leg pain.
- Patients whose pain has been persisted at least 3 weeks recently and who are necessary to care intermittent medical treatments (eg. medication, injection, physio therapy).
- Patients with pain, defined as an Visual Analogue Scale (VAS) value ≥ 50mm.
- Patients who are 19 - 70 years of age.
- Patients who agreed to voluntarily participate in this study and signed informed consent.
Exclusion Criteria:
- Patients who have been diagnosed with a serious disease that can cause low back pain (e.g., cancer, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equine compression, or other disqualifying conditions).
- Patients with progressive neurological deficit or severe neurological symptoms.
- Patients whose pain causes are not resulted from spine or resulted from soft tissue diseases(e.g., cancer, fibromyalgia, rheumatoid arthritis, gout).
- Patients with a chronic disease that could influences the effects of the treatment or the analysis of treatment results (e.g., cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, dementia, epilepsy, or other disqualifying conditions).
- Patients for whom acupuncture would be inappropriate or unsafe (e.g., hemorrhagic disease, clotting disorders, a history of receiving anticoagulant therapy, severe diabetes with a risk of infection, severe cardiovascular disease, or other disqualifying conditions)
- Patients who are currently pregnant or planning the pregnancy.
- Patients with psychiatric diseases.
- Patients who are participating in other clinical trial.
- Patients who are unable to sign informed consent.
- Patients who are judged to be inappropriate for the clinical study by the researchers, such as inability to read and write Korean.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Electroacupuncture and Usual care
15 minutes of electroacupuncture and usual care.
Usual care contains 15 minutes ICT(Interferential Current Therapy), 10 minutes hot pack or ice pack and education of patients.
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Electroacupuncture: Using 0.25 mm (diameter) X 0.40 mm (length) sized disposable stainless steel needles, electric stimulation will be applied with an electronic stimulator (ES-160, ITO co. LTD, Japan) 2 times/week × 4 weeks. Stimulation will be applied with the current in biphasic wave form. Acupuncture points are Jia-ji (Ex-B2, L3-L5; bilateral) as necessary points and reasonable points (according to decision of practitioner) as accessory points. Each session lasts 15 minutes. Usual care: Physical therapy and patient education will be performed 2 times per week for 4 weeks. ICT lasts 15 minutes and Hot or Ice pack lasts 10minutes. Doctors will educate patient physiology, pathology, and epidemiology of low back pain. And also suitable postures and exercises for low back pain will be educated. |
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Comparateur actif: usual care
15 minutes ICT, 10 minutes hot pack or ice pack and education of patients
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Usual care: Physical therapy and patient education will be performed 2 times per week for 4 weeks.
ICT lasts 15 minutes and Hot or Ice pack lasts 10minutes.
Doctors will educate patient physiology, pathology, and epidemiology of low back pain.
And also suitable postures and exercises for low back pain will be educated.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Visual Analogue Scale
Délai: up to 4 months
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up to 4 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Oswestry Disability Index
Délai: up to 4 months
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up to 4 months
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EuroQoL 5-Dimension Questionnaire
Délai: up to 4 months
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up to 4 months
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Byung-cheul Shin, Pusan National University Korean Medicine Hospital
Publications et liens utiles
Publications générales
- Heo I, Hwang MS, Hwang EH, Cho JH, Ha IH, Shin KM, Lee JH, Kim NK, Son DW, Shin BC. Electroacupuncture as a complement to usual care for patients with non-acute low back pain after back surgery: a pilot randomised controlled trial. BMJ Open. 2018 May 17;8(5):e018464. doi: 10.1136/bmjopen-2017-018464.
- Hwang MS, Heo KH, Cho HW, Shin BC, Lee HY, Heo I, Kim NK, Choi BK, Son DW, Hwang EH. Electroacupuncture as a complement to usual care for patients with non-acute pain after back surgery: a study protocol for a pilot randomised controlled trial. BMJ Open. 2015 Feb 4;5(2):e007031. doi: 10.1136/bmjopen-2014-007031.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2013012
- K13273 (Autre subvention/numéro de financement: Korea Institute of Oriental Medicine)
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