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

February 7, 2024 updated by: The Third People's Hospital of Hangzhou
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Hangzhou Third People's Hospital
        • Contact:
        • Contact:
          • Chengcheng Kong
          • Phone Number: 8613868078286

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: Medication Group
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.
Experimental: 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.
Other: EA Group
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.
Experimental: 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.
Other: EA+Medication Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Score change
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.
Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
McGill Pain Questionnaire Short Form (SF-MPQ)
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.
Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
Brief Pain Inventory Scale (BPI-SF)
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.
Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
Medical Outcomes Study Sleep Scale (MOS-SS)
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.
Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
Hamilton Depression Rating Scale (HAMD)Hamilton Anxiety Rating Scale (HAMA)
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
Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
Hamilton Depression Rating Scale (HAMD)
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
Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)
Short Form 36 Health Survey (SF-36)
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.
Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third People's Hospital of Hangzhou

Collaborators

The Third Affiliated hospital of Zhejiang Chinese Medical University

Investigators

  • Study Director: Pin Lin, The Hangzhou Third People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2024

Primary Completion (Estimated)

July 20, 2025

Study Completion (Estimated)

December 20, 2025

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZY-ZJ-KJ-23088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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