Postherpetic Neuralgia
Conditions
Keywords
Electroacupuncture, Postherpetic Neuralgia, Analgesic effect
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.
Interventions
Continue the electroacupuncture treatment as described above for 30 minutes.
Continue the sham electroacupuncture treatment as described above for 30 minutes.
Sponsors
Nanjing University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The randomization scheme is generated, validated and imported into the central randomization system by a statistician who do not participate in this trial by using R software. The central randomization system has set strict personnel permissions, and no one has right to view the randomization scheme except the highest-level system administrator. Patients and study investigators (i.e., outcome assessors, data recorders, data entry clerks and statistical analysts) will be blinded to the group assignment. Due to the nature of the intervention, acupuncturists will not be blinded to the treatment.
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.
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity (NRS-11) | Change from Baseline at 4 weeks after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity (NRS-11) | Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 1-month follow-up. | 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. |
| Change in pain intensity (VAS) | Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up. | Visual analogue scale (VAS): a horizontal line without verbal descriptors or numbers at intermediate points (0=no pain, 10=worst imaginable pain) |
| Interference of pain on sleep | 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up. | 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. |
| Change in mechanical pain threshold (MPT) | Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up. | Stimulated the most painful central part of PHN with a series of von Frey hairs (0.008-300 g). |
| Change in pain area of PHN (PAP) | Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up. | calculated by the researcher based on 45 body areas rating scale (BARS-45) which requires the use of height and weight of the patient. |
| Average number of pain episodes per day | 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up. | Painless: 0 times; Intermittent pain: 1-50 times (1-2, 3-5, 6-10, 11-50 optional); Persistent pain: \>50 times. |
| Average duration of each pain episode (ADEPE) | 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment and 1-month follow-up. | Duration ranges from 0 minutes (no pain) to 24 hours (persistent pain). |
| Change in the nature and intensity of pain | Change from Baseline at 4 weeks after treatment and 1-month follow-up. | short form of McGill pain questionnaire 2 (SF-MPQ-2): includes 22 items. |
| Change in degree of pain and its impact on work life, interpersonal relationships and sleep | Change from Baseline at 4 weeks after treatment and 1-month follow-up. | Zoster brief pain inventory (ZBPI) |
| Change in depression, anxiety and positive outlook scale (DAPOS) | Change from Baseline at 4 weeks after treatment and 1-month follow-up. | 11 items, combines depression (5 items), anxiety (3 items) and positive outlook (3 items). |
| Overall impression of PHN | Week 4 and week 8. | 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). |
Countries
China
Contacts
STUDY_DIRECTORJianhua Sun
Jiangsu Province Hospital of Traditional Chinese Medicine
PRINCIPAL_INVESTIGATORWenping Yao
Lianyungang Hospital of Traditional Chinese Medicine
PRINCIPAL_INVESTIGATORYongtao Liu
Huai'an Hospital of Traditional Chinese Medicine
PRINCIPAL_INVESTIGATORJuanjuan Shi
Affiliated Hospital of Nanjing University of Chinese Medicine
PRINCIPAL_INVESTIGATORHua Feng
Wuxi Hospital of Traditional Chinese Medicine
PRINCIPAL_INVESTIGATORChunxia Lu
Nantong Hospital of Traditional Chinese Medicine
PRINCIPAL_INVESTIGATORYanfang Liu
Shuyang Hospital of Traditional Chinese Medicine
Outcome results
None listed