The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia

Nanjing University of Traditional Chinese Medicine

Status: Completed

Conditions: Postherpetic Neuralgia

Treatments: Other: Sham electroacupuncture treatment; Other: Electroacupuncture treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04560361

2020NL-103-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 448 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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448 participants in 2 patient groups

Electroacupuncture group

Experimental group

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.

Treatment:

Other: Electroacupuncture treatment

Sham electroacupuncture group

Sham Comparator group

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.

Treatment:

Other: Sham electroacupuncture treatment