Combining electroacupuncture with pregabalin for treating trigeminal herpetic neuralgia
Efficacy of Electroacupuncture Combined With Pregabalin in the Treatment of Trigeminal Herpetic Neuralgia: a Multicenter Randomized Controlled Trial Study Protocol
This study is testing if combining electroacupuncture with pregabalin can help people with trigeminal herpetic neuralgia feel less pain compared to using either treatment alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | The Third People's Hospital of Hangzhou Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06261801 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of electroacupuncture (EA) combined with pregabalin in treating trigeminal herpetic neuralgia, a painful condition associated with herpes zoster. Participants will be randomly assigned to one of three groups: medication only, EA only, or a combination of both. The study aims to determine if EA can serve as a viable alternative to pregabalin, focusing on patient outcomes and pain relief. The trial will include patients aged 18 to 85 with specific pain levels and disease duration.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with a diagnosis of trigeminal herpetic neuralgia lasting 1 to 3 months and a moderate pain level.
Not a fit: Patients with severe organ damage, cognitive dysfunction, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more cost-effective treatment option for patients suffering from trigeminal herpetic neuralgia.
How similar studies have performed: Previous studies have shown promising results for electroacupuncture in pain management, suggesting potential success for this combined approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou, Zhejiang
- The Hangzhou Third People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Pin Lin
- Email: yjlp1@163.com
- Phone: 1358876268686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.