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

Status: Enrolling

Conditions: Trigeminal Herpetic Neuralgia

Treatments: Other: EA+Medication Group; Other: EA Group; Other: Medication Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06261801

GZY-ZJ-KJ-23088

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. meet the aforementioned diagnostic criteria for trigeminal ZAP, with a disease duration of 1 to 3 months;
2. have a visual analog scale (VAS) score of 4 points ≤ VAS ≤ 7 points;
3. be between 18 and 85 years old, regardless of gender;
4. have clear consciousness, the ability to distinguish pain, and complete basic communication;
5. voluntarily participate in the study, sign a written informed consent form, and fully understand the plan.

Exclusion criteria

1. do not meet the above-mentioned inclusion criteria;
2. have concomitant herpes zoster on the trunk or extremities, or other special types of herpes zoster like meningeal herpes zoster or visceral herpes zoster;
3. are pregnant or lactating patients;
4. are allergic to pregabalin or acupuncture stimulation;
5. have severe organ damage, cognitive dysfunction, mental disorder, aphasia, or other serious diseases that hinder cooperation with treatment;
6. have severe skin diseases;
7. have a pacemaker;
8. have been or are currently participating in other clinical studies within the past 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 3 patient groups

Medication Group

Active Comparator group

Description:

Participants in the medication group would take 150-mg pregabalin capsules orally twice daily (total daily dose, 300 mg) for 4 weeks. The follow-up period is 3 months.

Treatment:

Other: Medication Group

EA Group

Experimental group

Description:

The subjects in this group will receive 3 times per week, and 4 weeks of continuous intervention for a total of 12 times. The follow-up period is 3 months.

Treatment:

Other: EA Group

EA+Medication Group

Experimental group

Description:

The subjects in this group will receive 3 times per week, and 4 weeks of continuous intervention for a total of 12 times. The intervention including electroacupuncture(EA) treatment and combined with pregabalin (0.15g each time, twice daily). The follow-up period is 3 months.

Treatment:

Other: EA+Medication Group