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- Essai clinique NCT04250974
Evaluaing the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Distal Radius Fracture
Single-blinded, Randomized Preliminary Study Evaluating the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Distal Radius Fracture.
Single-blinded, randomized preliminary study evaluating the effects of electroacupuncture for postoperative pain relief in patients with distal radius fracture.
Distal radius fracture is extremely common, and it is about 10% of all fractures in the human body. Therefore, the distal radius is the most frequently fractured part of the upper limbs of the human body. Once the fracture occurs, internal fixation is the main surgical procedure. The postoperative analgesic method is generally oral or injection analgesic. In recent years, electroacupuncture(EA) has been widely used to relieve pain after surgery, and many studies have confirmed that it is effective. However, there is no evaluation of analgesic efficacy after the surgery of distal radius fracture. Therefore, it is hoped that the efficacy of EA for analgesia after the surgery of distal radius fracture is demonstrated by this study. And, the investigators also hope the investigators can reduce the use of painkillers through EA.
Methods: It is expected that 30 patients will be randomly assigned to the following groups: EA group,EA at points; non-point group, EA at non-points, control group without EA
- EA group:EA at points after surgery
- non-point group: EA at non-points after surgery
- Control group: no EA
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Single-blinded, randomized preliminary study evaluating the effects of electroacupuncture for postoperative pain relief in patients with distal radius fracture.
Distal radius fracture is extremely common, and it is about 10% of all fractures in the human body. Therefore, the distal radius is the most frequently fractured part of the upper limbs of the human body. Once the fracture occurs, internal fixation is the main surgical procedure. The postoperative analgesic method is generally oral or injection analgesic. In recent years, electroacupuncture(EA) has been widely used to relieve pain after surgery, and many studies have confirmed that it is effective. However, there is no evaluation of analgesic efficacy after the surgery of distal radius fracture. Therefore, it is hoped that the efficacy of EA for analgesia after the surgery of distal radius fracture is demonstrated by this study. And, the investigators also hope the investigators can reduce the use of painkillers through EA.
Methods: It is expected that 30 patients will be randomly assigned to the following groups: EA group,EA at points; non-point group, EA at non-points, control group without EA
- EA group:EA at points after surgery
- non-point group: EA at non-points after surgery
- Control group: no EA Mode of operation: After the patient has returned to the recovery room, perfom EA, and take the needle after 30 minutes. Perform another 30 minutes after 24 hours, and then statistics.
Acupoint selection:
- true acupoints: needles were inserted to Taichong (LR3 ) and Taixi (KI3) contralateral to the operated leg and deqi sensation elicited at acupoints
- false point: the needles were inserted to Kunlun(BL60) and Shugu(BL65) contralateral to the operated leg and deqi sensation elicited at acupoints
Data collection:
- Record the time required for the first injection of analgesics
- The number of doses of oral painkiller used in 36 hours after surgery (count)
- The number of doses of injection painkiller used in 36 hours after surgery (count)
- Use the visual analog scale (VAS) to assess the patient's pain level
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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No. 2, Yude Rd, North District, Taichung City
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Taichung, No. 2, Yude Rd, North District, Taichung City, Taïwan, 404
- Recrutement
- China Medical University 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:
- Orthopaedic specialist diagnoses distal radius fracture and undergoes internal fixation
- Age between 20 and 70
Exclusion Criteria:
- Allergic to painkillers
- Have a serious heart rhythm
- epilepsy
- Severe pulmonary heart disease
- History of mental illness
- History of drug abuse
- received acupuncture treatment within 1 month
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 |
|---|---|
|
Expérimental: electroacupuncture
electroacupuncture at points after surgery
|
acupuncture avec électricité
|
|
Comparateur factice: electroacupuncture non-point
electroacupuncture at non-points after surgery
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acupuncture avec électricité
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|
Aucune intervention: Control group
only oral or injection painkiller were used after surgery
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
the time required for the first injection of analgesics
Délai: in 36 hours after surgery
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Record the time required for the first injection of analgesics
|
in 36 hours after surgery
|
|
the number of doses of injection painkiller
Délai: in 36 hours after surgery
|
Record the number of doses of injection painkiller
|
in 36 hours after surgery
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
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
- CMUH108-REC1-140
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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