Efficacy of Electroacupuncture Combined With Pregabalin in the Treatment of Trigeminal Herpetic Neuralgia: a Multicenter Randomized Controlled Trial Study Protocol

Not Applicable

Recruiting

• Conditions: Trigeminal Herpetic Neuralgia
• Interventions: Other: EA Group; Other: EA+Medication Group; Other: Medication Group

• Registration Number: NCT06261801
• Lead Sponsor: The Third People's Hospital of Hangzhou

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2024-02-07
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-07-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EA Group	EA Group	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.
EA+Medication Group	EA+Medication Group	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.
Medication Group	Medication Group	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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Score change	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.

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HAMD)Hamilton Anxiety Rating Scale (HAMA)	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
McGill Pain Questionnaire Short Form (SF-MPQ)	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.
Medical Outcomes Study Sleep Scale (MOS-SS)	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.
Hamilton Depression Rating Scale (HAMD)	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
Brief Pain Inventory Scale (BPI-SF)	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.
Short Form 36 Health Survey (SF-36)	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.

Trial Locations

Locations (1)

The Hangzhou Third People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China