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

NCT06261801 | Recruiting DMC

• 1 other identifier: GZY-ZJ-KJ-23088
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigeminal Herpetic Neuralgia

Keywords

Electroacupuncture; pain; randomized controlled trial; protocol

Outcome Measures

Primary Outcomes (1)

• Visual Analog Score change

  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 Outcomes (6)

• 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)

• Brief Pain Inventory Scale (BPI-SF)

  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)

  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)

  Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)

• Hamilton Depression Rating Scale (HAMD)

  Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)

Study Arms (3)

Medication Group

ACTIVE COMPARATOR

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

EA Group

EXPERIMENTAL

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

EA+Medication Group

EXPERIMENTAL

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

Interventions

Medication Group OTHER

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.

Medication Group

EA Group OTHER

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.

EA Group

EA+Medication Group OTHER

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.

EA+Medication Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• have concomitant herpes zoster on the trunk or extremities, or other special types of herpes zoster like meningeal herpes zoster or visceral herpes zoster;
• are pregnant or lactating patients;
• are allergic to pregabalin or acupuncture stimulation;
• have severe organ damage, cognitive dysfunction, mental disorder, aphasia, or other serious diseases that hinder cooperation with treatment;
• have severe skin diseases;
• have a pacemaker;
• have been or are currently participating in other clinical studies within the past 3 months.

Sponsors & Collaborators

• The Third People's Hospital of Hangzhou: lead
• The Third Affiliated hospital of Zhejiang Chinese Medical University: collaborator

Study Sites (1)

The Hangzhou Third People's Hospital

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (8)

• Werner RN, Nikkels AF, Marinovic B, Schafer M, Czarnecka-Operacz M, Agius AM, Bata-Csorgo Z, Breuer J, Girolomoni G, Gross GE, Langan S, Lapid-Gortzak R, Lesser TH, Pleyer U, Sellner J, Verjans GM, Wutzler P, Dressler C, Erdmann R, Rosumeck S, Nast A. European consensus-based (S2k) Guideline on the Management of Herpes Zoster - guided by the European Dermatology Forum (EDF) in cooperation with the European Academy of Dermatology and Venereology (EADV), Part 2: Treatment. J Eur Acad Dermatol Venereol. 2017 Jan;31(1):20-29. doi: 10.1111/jdv.13957. Epub 2016 Nov 2.

  PMID: 27579792 RESULT

• Johnson RW, Rice AS. Clinical practice. Postherpetic neuralgia. N Engl J Med. 2014 Oct 16;371(16):1526-33. doi: 10.1056/NEJMcp1403062. No abstract available.

  PMID: 25317872 RESULT

• Wood M. Understanding pain in herpes zoster: an essential for optimizing treatment. J Infect Dis. 2002 Oct 15;186 Suppl 1:S78-82. doi: 10.1086/342958.

  PMID: 12353191 RESULT

• Kawai K, Gebremeskel BG, Acosta CJ. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ Open. 2014 Jun 10;4(6):e004833. doi: 10.1136/bmjopen-2014-004833.

  PMID: 24916088 RESULT

• Gan EY, Tian EA, Tey HL. Management of herpes zoster and post-herpetic neuralgia. Am J Clin Dermatol. 2013 Apr;14(2):77-85. doi: 10.1007/s40257-013-0011-2.

  PMID: 23456596 RESULT

• Oster G, Harding G, Dukes E, Edelsberg J, Cleary PD. Pain, medication use, and health-related quality of life in older persons with postherpetic neuralgia: results from a population-based survey. J Pain. 2005 Jun;6(6):356-63. doi: 10.1016/j.jpain.2005.01.359.

  PMID: 15943957 RESULT

• Dubinsky RM, Kabbani H, El-Chami Z, Boutwell C, Ali H; Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter: treatment of postherpetic neuralgia: an evidence-based report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2004 Sep 28;63(6):959-65. doi: 10.1212/01.wnl.0000140708.62856.72.

  PMID: 15452284 RESULT

• Dworkin RH, O'Connor AB, Kent J, Mackey SC, Raja SN, Stacey BR, Levy RM, Backonja M, Baron R, Harke H, Loeser JD, Treede RD, Turk DC, Wells CD. Interventional management of neuropathic pain: NeuPSIG recommendations. Pain. 2013 Nov;154(11):2249-2261. doi: 10.1016/j.pain.2013.06.004. Epub 2013 Jun 6.

  PMID: 23748119 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pin Lin

  The Hangzhou Third People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Pin Lin

CONTACT

1358876268686; yjlp1@163.com

Chengcheng Kong

CONTACT

8613868078286; njmukcc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: February 7, 2024
• Primary Completion: July 20, 2025
• Study Completion: December 20, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)