Efficacy of Electroacupuncture Combined With Pregabalin in the Treatment of Trigeminal Herpetic Neuralgia: a Multicenter Randomized Controlled Trial Study Protocol
The Third People's Hospital of Hangzhou
102 participants
Feb 7, 2024
INTERVENTIONAL
Conditions
Summary
Trigeminal herpetic neuralgia is a common type of Zoster-associated Pain (ZAP), which troubles individuals in all ages and burdens society all over the world. Eleactroaupuncture (EA) is increasingly used in the treatment of ZAP due to its advantages such as low price, high safety, no adverse reactions, and high patient acceptance. Therefore, it is necessary to conduct randomized controlled trials to evaluate the effectiveness and safety of EA on ZAP and whether EA can be used as a substitute for pregabalin.
Eligibility
Inclusion Criteria12
- meet the aforementioned diagnostic criteria for trigeminal ZAP, with a disease duration of 1 to 3 months;
- have a visual analog scale (VAS) score of 4 points ≤ VAS ≤ 7 points;
- be between 18 and 85 years old, regardless of gender;
- have clear consciousness, the ability to distinguish pain, and complete basic communication;
- voluntarily participate in the study, sign a written informed consent form, and fully understand the plan.
- have concomitant herpes zoster on the trunk or extremities, or other special types of herpes zoster like meningeal herpes zoster or visceral herpes zoster;
- are pregnant or lactating patients;
- are allergic to pregabalin or acupuncture stimulation;
- have severe organ damage, cognitive dysfunction, mental disorder, aphasia, or other serious diseases that hinder cooperation with treatment;
- have severe skin diseases;
- have a pacemaker;
- have been or are currently participating in other clinical studies within the past 3 months.
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Interventions
Participants in the medication group would take 150-mg pregabalin capsules (manufactured by Pfizer Pharmaceuticals Co., Ltd) orally twice daily (total daily dose, 300 mg) for 4 weeks.
Acupoints selection: Ashi acupoint, Sibai acupoint (ST2), Xiaguan acupoint (ST7), and Dicang acupoint (ST4) on the affected side. Acupoints for the diseased branches (all taken from the affected side): eye branch and Tongziliao point (GB1), the maxillary branch is taken from the Quanliao point (SI18), and the mandibular branch is taken from the Jiache point (ST6).Shenting point (DU24), Baihui point (DU20), Hegu point (LI4), Waiguan point (TE5), Yanglingquan point (GB34), and Taichong point (LR3) on the affected side Operation: The EA apparatus will be applied on the Ashi point and (LI4 - TE5). The treatment will last for 30 minutes and the electrical stimulation will be set as 2/100Hz in frequency.
Participants in the EA+Medication group would receive both EA and medical treatement. The acupoints and their location, needles, the settings of the EA device are the same as EA Group's; in the meanwhile, the medication and its dosage is the same as Medication Group's.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06261801