Clinical trial NCT06261801: Efficacy of Electroacupuncture Combined With Pregabalin in the Treatment of Trigeminal Herpetic Neuralgia: a Multicenter Randomized Controlled Trial Study Protocol
Official title: Efficacy of Electroacupuncture Combined With Pregabalin in the Treatment of Trigeminal Herpetic Neuralgia: a Multicenter Randomized Controlled Trial Study Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trigeminal Herpetic Neuralgia
Keywords: Electroacupuncture
pain
randomized controlled trial
protocol
Lead sponsor: The Third People's Hospital of Hangzhou
Sponsor class: OTHER
Collaborators: name: The Third Affiliated hospital of Zhejiang Chinese Medical University
First posted: 2024-02-15
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Visual Analog Score change
timeFrame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
Secondary outcomes:
measure: McGill Pain Questionnaire Short Form (SF-MPQ)
timeFrame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
measure: Brief Pain Inventory Scale (BPI-SF)
timeFrame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
measure: Medical Outcomes Study Sleep Scale (MOS-SS)
timeFrame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
measure: Hamilton Depression Rating Scale (HAMD)Hamilton Anxiety Rating Scale (HAMA)
timeFrame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
measure: Hamilton Depression Rating Scale (HAMD)
timeFrame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
measure: Short Form 36 Health Survey (SF-36)
timeFrame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Hangzhou Third People's Hospital
state: Zhejiang
Study officials:
affiliation: The Hangzhou Third People's Hospital
name: Pin Lin
role: STUDY_DIRECTOR
References:
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