Clinical trial NCT04560361: The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia
Official title: The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postherpetic Neuralgia
Keywords: Electroacupuncture
Postherpetic Neuralgia
Analgesic effect
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 448
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain intensity (NRS-11)
timeFrame: Change from Baseline at 4 weeks after treatment
Secondary outcomes:
measure: Change in pain intensity (VAS)
timeFrame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
measure: Change in the interference of pain on sleep
timeFrame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
measure: Change in mechanical pain threshold (MPT)
timeFrame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
measure: Change in pain area of PHN (PAP)
timeFrame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
measure: Change in average number of pain episodes per day
timeFrame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
measure: Change in average duration of each pain episode (ADEPE)
timeFrame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
measure: Change in the nature and intensity of pain
timeFrame: Change from Baseline at 4 weeks after treatment
measure: Change in degree of pain and its impact on work life, interpersonal relationships and sleep
timeFrame: Change from Baseline at 4 weeks after treatment
measure: Change in depression, anxiety and positive outlook scale (DAPOS)
timeFrame: Change from Baseline at 4 weeks after treatment
measure: Change in overall impression of PHN
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Huai'an
country: China
facility: Huai'an Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Lianyungang
country: China
facility: Lianyungang Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Chinese Medicine
state: Jiangsu
city: Nantong
country: China
facility: Nantong Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Suqian
country: China
facility: Shuyang Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Hospital of Traditional Chinese Medicine
state: Jiangsu
Study officials:
affiliation: Jiangsu Province Hospital of Traditional Chinese Medicine
name: Jianhua Sun
role: STUDY_DIRECTOR
affiliation: Lianyungang Hospital of Traditional Chinese Medicine
name: Wenping Yao
role: PRINCIPAL_INVESTIGATOR
affiliation: Huai'an Hospital of Traditional Chinese Medicine
name: Yongtao Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Nanjing University of Chinese Medicine
name: Juanjuan Shi
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuxi Hospital of Traditional Chinese Medicine
name: Hua Feng
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantong Hospital of Traditional Chinese Medicine
name: Chunxia Lu
role: PRINCIPAL_INVESTIGATOR
affiliation: Shuyang Hospital of Traditional Chinese Medicine
name: Yanfang Liu
role: PRINCIPAL_INVESTIGATOR
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