The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia

Postherpetic Neuralgia Clinical Trial

Official title:

The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia: a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04560361
• Other study ID #: 2020NL-103-02
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2020
• Est. completion date: October 30, 2023

Study information

• Verified date: March 2023
• Source: Nanjing University of Traditional Chinese Medicine
• Contact: Jianhua Sun
• Phone: +86 25-86617141-31300
• Email: 377201634[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators designed the multicenter randomized parallel controlled clinical trial of electroacupuncture on PHN which is rigorously designed and have an appropriate sample size, aiming to evaluate the efficacy and safety of electroacupuncture in pain relieving and pain removing in the treatment of patients with PHN.

Description:

Postherpetic neuralgia(PHN) is the most common complication of herpes zoster, is a severe and intractable pain with a high incidence. Nearly 50% of PHN patients have experienced persistent pain for more than one year. Although it is not directly life-threatening, will lead to sleep disorders, even depression, seriously affecting the quality of life of patients. This project is a multi-center randomized controlled trial, which will recruit 448 patients with PHN in 7 hospitals, aiming to evaluate the analgesic effect and safety of electroacupuncture on postherpetic neuralgia, and provide evidence-based medical evidence for electroacupuncture treatment of PHN.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 448
• Est. completion date: October 30, 2023
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients who meet the diagnostic criteria for postherpetic neuralgia (with a clear history of acute herpes zoster, and the duration of postherpetic pain exceeds 90 days)

• Aged 45 to 75 years old

• Patients who were diagnosed with moderate or above pain during the observation period (the daily pain score was continuously collected within 7 days during the observation period, and the average NRS-11 pain score was >=4)

• Subjects who did not participate in other ongoing clinical studies

• Sign informed consent and volunteer to participate in the study

Exclusion Criteria:

• Patients who are currently receiving or receiving more than one of the "permitted combinations" or any "prohibited combination and treatment" for PHN listed in the following part at least 14 days before screening, and are unwilling to undergo washout period, or patients with serious safety problems during washout period or observation period

• Patients who are expected to receive any new prescription drug or other treatment for PHN after the start of the trial

• Patients with serious uncontrolled medical conditions, such as cardiovascular, lung, liver, kidney, gastrointestinal tract, metabolism, endocrine, nervous system, respiratory system, urogenital system and other serious diseases, or systemic organ dysfunction, malignant tumor, hematologic disease such as bleeding tendency or coagulation dysfunction, serious mental illness such as depression or schizophrenia Symptoms, hepatitis B antigen or hepatitis C antibody positive known state or history of immune dysfunction, history of HIV infection, etc.

• Patients with severe pain unrelated to PHN, such as after surgery for clinical major diseases

• Patients with PHN who have received nerve intervention or other neurosurgical treatment, such as selective nerve damage, percutaneous radiofrequency thermocoagulation or pulsed nerve modulation technology, etc.

• Patients with some special types of herpes zoster, such as those with meninges, cornea, conjunctiva, ear involvement, visceral herpes zoster, generalized herpes zoster

• Patients with skin ulceration, new herpes, or skin infection

• Patients with cardiac pacemaker, metal allergy or severe fear of needle

• Patients who are unable to give full informed consent or cannot cooperate with pain scale assessment due to mental, mental, linguistic or behavioral disorders

• Patients who have poor compliance or are prone to fall off due to other reasons, such as the current residence is not in the city where the recruitment hospital is located, or the working environment changes frequently

• Pregnant and lactating women

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

Other:
• Electroacupuncture treatment
Continue the electroacupuncture treatment as described above for 30 minutes.
• Sham electroacupuncture treatment
Continue the sham electroacupuncture treatment as described above for 30 minutes.

Locations

Country	Name	City	State
China	Huai'an Hospital of Traditional Chinese Medicine	Huai'an	Jiangsu
China	Lianyungang Hospital of Traditional Chinese Medicine	Lianyungang	Jiangsu
China	Jiangsu Province Hospital of Chinese Medicine	Nanjing	Jiangsu
China	Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine	Nanjing	Jiangsu
China	Nantong Hospital of Traditional Chinese Medicine	Nantong	Jiangsu
China	Shuyang Hospital of Traditional Chinese Medicine	Suqian	Jiangsu
China	Wuxi Hospital of Traditional Chinese Medicine	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (7)

Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016. — View Citation

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. — View Citation

Pei W, Zeng J, Lu L, Lin G, Ruan J. Is acupuncture an effective postherpetic neuralgia treatment? A systematic review and meta-analysis. J Pain Res. 2019 Jul 16;12:2155-2165. doi: 10.2147/JPR.S199950. eCollection 2019. — View Citation

van Hecke O, Austin SK, Khan RA, Smith BH, Torrance N. Neuropathic pain in the general population: a systematic review of epidemiological studies. Pain. 2014 Apr;155(4):654-662. doi: 10.1016/j.pain.2013.11.013. Epub 2013 Nov 26. Erratum In: Pain. 2014 Sep;155(9):1907. — View Citation

Wang L, Qiu L, Zheng X, Ouyang J, Zhang M, He L, Zeng S, Liu B, Peng J. Effectiveness of electroacupuncture at Jiaji acupoints (EX-B2), plus moxibustion and intermediate on postherpetic neuralgia: a randomized controlled trial. J Tradit Chin Med. 2020 Feb;40(1):121-127. — View Citation

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 1: Diagnosis. J Eur Acad Dermatol Venereol. 2017 Jan;31(1):9-19. doi: 10.1111/jdv.13995. Epub 2016 Nov 2. — View Citation

Wu CH, Lv ZT, Zhao Y, Gao Y, Li JQ, Gao F, Meng XF, Tian B, Shi J, Pan HL, Li M. Electroacupuncture improves thermal and mechanical sensitivities in a rat model of postherpetic neuralgia. Mol Pain. 2013 Apr 3;9:18. doi: 10.1186/1744-8069-9-18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity (NRS-11)	11-point numeric rating scale (NRS-11): range from 0 (no pain) to 10 (worst possible pain), with 1-3 points representing mild pain, 4-6 points representing moderate pain, and 7-10 points representing severe pain. A reduction of =30% in NRS-11 scores from baseline were considered responders.	Change from Baseline at 4 weeks after treatment
Secondary	Change in pain intensity (VAS)	Visual analogue scale (VAS): a horizontal line without verbal descriptors or numbers at intermediate points (0=no pain, 10=worst imaginable pain)	Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
Secondary	Change in the interference of pain on sleep	Verbal rating scale (VRS): 4 levels.; Level 0: No pain.; Level I (mild): Pain but tolerable, normal life, no interference with sleep.; Level II (moderate): Pain is obvious, unbearable, requires analgesic medication, and sleep is disturbed.; Level III: Severe pain, unbearable, analgesic medication, severe interference with sleep, accompanied by autonomic dysfunction or passive positions.	Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
Secondary	Change in mechanical pain threshold (MPT)	Stimulated the most painful central part of PHN with a series of von Frey hairs (0.008-300 g).	Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
Secondary	Change in pain area of PHN (PAP)	calculated by the researcher based on 45 body areas rating scale (BARS-45) which requires the use of height and weight of the patient.	Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
Secondary	Change in average number of pain episodes per day	Painless: 0 times; Intermittent pain: 1-50 times (1-2, 3-5, 6-10, 11-50 optional); Persistent pain: >50 times.	Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
Secondary	Change in average duration of each pain episode (ADEPE)	Duration ranges from 0 minutes (no pain) to 24 hours (persistent pain).	Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
Secondary	Change in the nature and intensity of pain	short form of McGill pain questionnaire 2 (SF-MPQ-2): includes 22 items.	Change from Baseline at 4 weeks after treatment
Secondary	Change in degree of pain and its impact on work life, interpersonal relationships and sleep	Zoster brief pain inventory (ZBPI)	Change from Baseline at 4 weeks after treatment
Secondary	Change in depression, anxiety and positive outlook scale (DAPOS)	11 items, combines depression (5 items), anxiety (3 items) and positive outlook (3 items).	Change from Baseline at 4 weeks after treatment
Secondary	Change in overall impression of PHN	Patient global impression of change (PGIC): Participants were asked to describe their overall impression of change of their condition/pain by answering the following question: "Compared to your pain at admission to the project, how much has it changed?" (categories: much improved = 1, mildly improved = 2, unchanged = 3, mildly worsened = 4, much worsened = 5).	4 weeks