The Hangzhou Third People's Hospital
Hangzhou, Zhejiang, 310009, China
Location status: Recruiting
NCT Number: NCT06261801
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310009, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
Intensity of pain range (lately 3 days' average): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain.
Time frame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
SF-MPQ focuses on the characteristics, intensity, syndrome and changes of pain during treatment without taking too much time, so it can sensitively reflect clinical changes and reflect the effectiveness of treatment.
Time frame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
BPI-SF includes descriptive words such as the cause of pain, nature of pain, impact on life, and location of pain, which are used to describe the degree of pain and evaluate pain in various aspects.
Time frame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
The MOS-SS consists of 12 items related to sleep quality over a 4-week recall period.
Time frame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
HAMA will be used to assess the anxiety status of the participants
Time frame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
HAMD will be used to assess the depression status of the participants
Time frame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
The SF-36 is a questionnaire with proven reliability and validity and is widely used to assess people's quality of life.
Contact information is provided by the study sponsor or research team.
Chengcheng Kong
CONTACT
Pin Lin
CONTACT
The Third People's Hospital of Hangzhou
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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