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The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia

Primary Purpose

Postherpetic Neuralgia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electroacupuncture treatment
Sham electroacupuncture treatment
Sponsored by
Nanjing University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postherpetic Neuralgia focused on measuring Electroacupuncture, Postherpetic Neuralgia, Analgesic effect

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Huai'an Hospital of Traditional Chinese Medicine
  • Lianyungang Hospital of Traditional Chinese MedicineRecruiting
  • Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese MedicineRecruiting
  • Jiangsu Province Hospital of Chinese Medicine
  • Nantong Hospital of Traditional Chinese Medicine
  • Shuyang Hospital of Traditional Chinese Medicine
  • Wuxi Hospital of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Electroacupuncture group

Sham electroacupuncture group

Arm Description

Choose 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.

Participants 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 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 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 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 in average duration of each pain episode (ADEPE)
Duration ranges from 0 minutes (no pain) to 24 hours (persistent pain).
Change in the nature and intensity of pain
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
Zoster brief pain inventory (ZBPI)
Change in depression, anxiety and positive outlook scale (DAPOS)
11 items, combines depression (5 items), anxiety (3 items) and positive outlook (3 items).
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).

Full Information

First Posted
September 1, 2020
Last Updated
March 21, 2023
Sponsor
Nanjing University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04560361
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia
Keywords
Electroacupuncture, Postherpetic Neuralgia, Analgesic effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
448 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture group
Arm Type
Experimental
Arm Description
Choose 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.
Arm Title
Sham electroacupuncture group
Arm Type
Sham Comparator
Arm Description
Participants 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.
Intervention Type
Other
Intervention Name(s)
Electroacupuncture treatment
Intervention Description
Continue the electroacupuncture treatment as described above for 30 minutes.
Intervention Type
Other
Intervention Name(s)
Sham electroacupuncture treatment
Intervention Description
Continue the sham electroacupuncture treatment as described above for 30 minutes.
Primary Outcome Measure Information:
Title
Change in pain intensity (NRS-11)
Description
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.
Time Frame
Change from Baseline at 4 weeks after treatment
Secondary Outcome Measure Information:
Title
Change in pain intensity (VAS)
Description
Visual analogue scale (VAS): a horizontal line without verbal descriptors or numbers at intermediate points (0=no pain, 10=worst imaginable pain)
Time Frame
Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
Title
Change in the interference of pain on sleep
Description
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.
Time Frame
Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
Title
Change in mechanical pain threshold (MPT)
Description
Stimulated the most painful central part of PHN with a series of von Frey hairs (0.008-300 g).
Time Frame
Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
Title
Change in pain area of PHN (PAP)
Description
calculated by the researcher based on 45 body areas rating scale (BARS-45) which requires the use of height and weight of the patient.
Time Frame
Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
Title
Change in average number of pain episodes per day
Description
Painless: 0 times; Intermittent pain: 1-50 times (1-2, 3-5, 6-10, 11-50 optional); Persistent pain: >50 times.
Time Frame
Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
Title
Change in average duration of each pain episode (ADEPE)
Description
Duration ranges from 0 minutes (no pain) to 24 hours (persistent pain).
Time Frame
Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment
Title
Change in the nature and intensity of pain
Description
short form of McGill pain questionnaire 2 (SF-MPQ-2): includes 22 items.
Time Frame
Change from Baseline at 4 weeks after treatment
Title
Change in degree of pain and its impact on work life, interpersonal relationships and sleep
Description
Zoster brief pain inventory (ZBPI)
Time Frame
Change from Baseline at 4 weeks after treatment
Title
Change in depression, anxiety and positive outlook scale (DAPOS)
Description
11 items, combines depression (5 items), anxiety (3 items) and positive outlook (3 items).
Time Frame
Change from Baseline at 4 weeks after treatment
Title
Change in overall impression of PHN
Description
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).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua Sun
Phone
+86 25-86617141-31300
Email
377201634@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qianyan Liu
Phone
+86 18236918234
Email
lqyfamily@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhua Sun
Organizational Affiliation
Jiangsu Province Hospital of Chinese Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wenping Yao
Organizational Affiliation
Lianyungang Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yongtao Liu
Organizational Affiliation
Huai'an Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juanjuan Shi
Organizational Affiliation
Nanjing University of Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hua Feng
Organizational Affiliation
Wuxi Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chunxia Lu
Organizational Affiliation
Nantong Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yanfang Liu
Organizational Affiliation
Shuyang Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huai'an Hospital of Traditional Chinese Medicine
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
223001
Country
China
Individual Site Status
Completed
Facility Name
Lianyungang Hospital of Traditional Chinese Medicine
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenping Yao
Facility Name
Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juanjuan Shi
Facility Name
Jiangsu Province Hospital of Chinese Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Completed
Facility Name
Nantong Hospital of Traditional Chinese Medicine
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Individual Site Status
Completed
Facility Name
Shuyang Hospital of Traditional Chinese Medicine
City
Suqian
State/Province
Jiangsu
ZIP/Postal Code
223600
Country
China
Individual Site Status
Completed
Facility Name
Wuxi Hospital of Traditional Chinese Medicine
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214071
Country
China
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Case Report Form, Electronic Data Capture(EDC)
IPD Sharing Time Frame
Within six months after the trial complete
IPD Sharing Access Criteria
Use the EDC system of the Science and Technology Department of Jiangsu Provincial Hospital of Chinese Medicine to disclose the original data
IPD Sharing URL
http://jshtcm.ecrfdata.com/edc/inx/jshtcm
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The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia

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