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Postherpetic NeuralgiaNCT04560361

The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia

A study testing Electroacupuncture treatment in people with Postherpetic Neuralgia, run by Nanjing University of Traditional Chinese Medicine at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Postherpetic Neuralgia
What is being tested?
Electroacupuncture treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
448 participants
Where
7 sitesChina
Study dates
14 Oct 2020to 28 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Huai'an Hospital of Traditional Chinese Medicine

    Huai'an, Jiangsu, 223001

  • Lianyungang Hospital of Traditional Chinese Medicine

    Lianyungang, Jiangsu, 222004

  • Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine

    Nanjing, Jiangsu, 210001

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing, Jiangsu, 210029

  • Nantong Hospital of Traditional Chinese Medicine

    Nantong, Jiangsu, 226001

  • Shuyang Hospital of Traditional Chinese Medicine

    Suqian, Jiangsu, 223600

  • Wuxi Hospital of Traditional Chinese Medicine

    Wuxi, Jiangsu, 214071

Other trials in China

About this study

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

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.

Read the detailed 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.

Being tested
Electroacupuncture treatment, Sham electroacupuncture treatment
Keywords
Electroacupuncture, Postherpetic Neuralgia, Analgesic effect
Medical subject headings
Neuralgia, Postherpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electroacupuncture treatmentOther

    Continue the electroacupuncture treatment as described above for 30 minutes.

  • Sham electroacupuncture treatmentOther

    Continue the sham electroacupuncture treatment as described above for 30 minutes.

Study groups in NCT04560361
Study groupRoleWhat they receive
Electroacupuncture groupExperimentalChoose the appropriate position according to the patient's herpes site, and routinely disinfect the skin. Paste the fixed insulating pad on the acupoint, and use a 0.30×40mm acupuncture needle to penetrate the skin 10mm obliquely through the fixed insulating gasket at Ashi point; According to the above operation, the SJ6 and GB34 point of the affected side are directly penetrated into the skin 15-20mm. The local Ashi point connects the two poles of the electroacupuncture device according to the first and last points of the long axis of the painful part, and the SJ6 and GB34 point on the affected side are connected to the poles of the electroacupuncture device. Electroacupuncture waveform is continuous wave, frequency is 2Hz, and current intensity is 1-5mA (causing slight tremor of the skin around the acupuncture point without pain). Continue the electroacupuncture treatment for 30 minutes.
Receives: Other: Electroacupuncture treatment
Sham electroacupuncture groupSham comparatorParticipants randomly assigned to the sham electroacupuncture (SA) group received sham electroacupuncture by using placebo blunt needles at the same acupoints. After disinfecting the skin and placing the sterile insulating adhesive pads on unilateral Zhigou, Yanglingquan and Ashi points, placebo blunt needles are inserted through the pads and reach the insulating adhesive layer, causing the participants to feel the needle resistance (a sensation of needle insertion). Other procedures, electrode placements, parameter of electroacupuncture apparatus and treatment settings are the same as in the EA group, but with no skin penetration or electricity output.
Receives: Other: Sham electroacupuncture treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from Baseline at 4 weeks after treatment

Secondary outcomes (11)

  1. Change in pain intensity (NRS-11)

    The NRS-11 score ranges 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.

    Measured: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 1-month follow-up.

  2. 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)

    Measured: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up.

  3. Interference of pain on sleep

    Verbal rating scale (VRS): 4 levels.

    1. Level 0: No pain.
    2. Level I (mild): Pain but tolerable, normal life, no interference with sleep.
    3. Level II (moderate): Pain is obvious, unbearable, requires analgesic medication, and sleep is disturbed.
    4. Level III: Severe pain, unbearable, analgesic medication, severe interference with sleep, accompanied by autonomic dysfunction or passive positions.

    Measured: 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up.

  4. 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).

    Measured: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up.

  5. 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.

    Measured: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up.

  6. 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.

    Measured: 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up.

  7. Average duration of each pain episode (ADEPE)

    Duration ranges from 0 minutes (no pain) to 24 hours (persistent pain).

    Measured: 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment and 1-month follow-up.

  8. Change in the nature and intensity of pain

    short form of McGill pain questionnaire 2 (SF-MPQ-2): includes 22 items.

    Measured: Change from Baseline at 4 weeks after treatment and 1-month follow-up.

  9. Change in degree of pain and its impact on work life, interpersonal relationships and sleep

    Zoster brief pain inventory (ZBPI)

    Measured: Change from Baseline at 4 weeks after treatment and 1-month follow-up.

  10. Change in depression, anxiety and positive outlook scale (DAPOS)

    11 items, combines depression (5 items), anxiety (3 items) and positive outlook (3 items).

    Measured: Change from Baseline at 4 weeks after treatment and 1-month follow-up.

  11. 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).

    Measured: Week 4 and week 8.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2020
  2. Study start14 Oct 2020
  3. Primary completion27 Aug 2022
  4. Study completion28 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Using the center stratification block randomization method, the center is used as the stratification factor, and subjects were randomly assigned to the electroacupuncture group and the sham electroacupuncture group at a ratio of 1:1. The central randomization system is used for randomization operations.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
448 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04560361
Sponsor's protocol ID
2020NL-103-02
Status last verified
Sep 2026
First submitted
1 Sep 2020
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Case Report Form, Electronic Data Capture(EDC)

Publications

  • 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.

    PubMed 24291734

  • 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.

    PubMed 24916088

  • 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.

    PubMed 32227773

  • 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.

    PubMed 23551937

  • 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.

    PubMed 31410050

  • 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.

    PubMed 27804172

  • 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.

    PubMed 21621130

  • Chen L, Liu Q, Pei L, Geng H, Liu Y, Yang Z, Ding M, Shen R, Chen M, Lu J, You D, Wu X, Zhou J, Hu L, Guo B, Sun S, Chen F, Zhao Z, Zhai Y, Chen Z, Li Z, Yao W, Feng H, Lu C, Liu Y, Shi J, Guo J, Sun J. Effect of Electroacupuncture on Postherpetic Neuralgia: A Randomized Clinical Trial. JAMA Neurol. 2026 Jul 1;83(7):667-676. doi: 10.1001/jamaneurol.2026.1443.

    PubMed 42189557

  • Liu Q, Wu X, Guo J, Gao J, Liu B, Wang Y, Xia M, Pei L, Sun J. Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia: A Trial Protocol for a Multicenter Randomized Controlled Trial. Pain Ther. 2021 Dec;10(2):1755-1771. doi: 10.1007/s40122-021-00283-8. Epub 2021 Jul 12.

    PubMed 34254233

Questions about this trial

What is this clinical trial studying?

A study testing Electroacupuncture treatment in people with Postherpetic Neuralgia, run by Nanjing University of Traditional Chinese Medicine at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain intensity (NRS-11) (time frame: Change from Baseline at 4 weeks after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04560361, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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