A Randomized Controlled Study on the Treatment of Postherpetic Neuralgia in the Head and Face With Superficial Needling Combined With Electroacupuncture

Based on the inclusion and exclusion criteria, patients with head and face PHN who met the requirements were selected as trial subjects, and the efficacy was clarified in a randomized controlled design trial. The visual analog score VAS was used as the primary evaluation index, and the depression self-assessment scale score , Hamilton depression scale, Pittsburgh sleep quality index scale, and quality of life evaluation scale (SF-36) were used as the secondary evaluation indexes, and oral pregabalin was used as the control group, and the subjects in the pregabalin and the plexus superficial stabbing combined with electroacupuncture groups were observed respectively at the time of Before treatment, immediately after the first treatment, after 2 days of treatment, after 2 weeks of treatment, after 4 weeks of treatment, after 1 month of follow-up after the end of treatment and after 2 months of follow-up after the end of treatment.

Study Overview

• Status: Recruiting
• Conditions: Postherpetic Neuralgia; Electroacupuncture; Infrared Thermography
• Intervention / Treatment: Other: electroacupuncture; Drug: Pregabalin

Detailed Description

On the one hand, it was clarified whether plexus needle shallow stabbing combined with electroacupuncture for the treatment of PHN in the head and face has clear and stable advantages in pain reduction, improvement of mood, sleep quality and quality of life, and formed the clinical standardization of plexus needle shallow stabbing combined with electroacupuncture for the treatment of postherpetic neuralgia in the head and face, which in turn lays the foundation for the further popularization of acupuncture for the treatment of postherpetic neuralgia in the head and face, and also provides a new, scientific and effective way of thinking about clinical analgesic therapies for postherpetic neuralgia.

On the other hand, this study will clarify the correlation between facial thermal radiation characteristics and clinical symptoms in patients with head and face PHN, and apply infrared thermography as an objective evaluation of the efficacy index of plexus needling and shallow stabbing combined with electroacupuncture in the treatment of head and face PHN, which will provide a new method for objectively verifying the clinical efficacy of PHN.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoyu Li; Phone Number: +8618758240921; Email: 673426608@qq.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310053
      • Recruiting
      • Xiaoyu Li
      • Contact: Xiaoyu Li; Phone Number: +8618758240921; Email: 673426608@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

① Meet the diagnostic criteria in the 2016 Chinese Expert Consensus on the Diagnosis and Treatment of Postherpetic Neuralgia; ② Age 50-80 years (including telangiectasia), gender is not limited; ③ Have a history of herpes zoster on the head and face, and the lesions on the head and face have been healed and subsided, and the symptoms of neuralgia lasted ≥1 month after lesions were healed, with baseline scores of ≥4 on the Facial Pain Profile, and abnormal sensation of the skin around the lesions, pain sensitivity; ④ Be conscious and have a clear sense of pain and discriminative ability; ⑤ Sign the informed consent to participate in this study voluntarily. Only those who satisfy the above 5 items at the same time can be included in this study.

Exclusion Criteria:

① those who did not meet the above diagnostic criteria; ② herpes zoster occurring in the perineum, or special types such as visceral herpes zoster, meningeal herpes zoster, and generalized herpes zoster; ③ those who were taking oral pregabalin at a dose of less than 0.2 g or more than 0.6 g per day before inclusion to relieve analgesia; ④ those who had a serious adverse reaction to pregabalin, were allergic to acupuncture, or belonged to patients who were within the range of contraindications to electro-acupuncture; ⑤ Combined with severe cardiac, hepatic, renal damage, epilepsy, head injury, or cognitive dysfunction, aphasia, psychiatric disorders, and other major diseases, who are unable to cooperate with the treatment; ⑥ Combined with poorly controlled hypertension and diabetes mellitus patients; ⑦ Pregnant or breastfeeding patients; ⑧ Patients who are currently participating in other studies, and who have been enrolled in other clinical trials within the last 3 months. Anyone who meets any of these criteria will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: therapy group; Subjects in this group will be treated with Cluster needle shallow stabbing combined with electroacupuncture.The treatment time was 60 minutes each time, once every other day, and the treatment was carried out 3 times a week for 4 consecutive weeks, for a total of 12 treatments.	Other: electroacupuncture; The patient takes the supine position, the whole body relaxes, the facial skin is routinely sterilized. Local acupuncture points along the head and face herpes zoster lesion branches with 0.18 × 25 mm millimetre needle series of shallow stabbing method row stabbing method.Han's Acupoint Neurostimulator (model HANS-200) was selected, local acupoints were chosen as Xiaguan+Quanliao or Xiaguan+Jiache, and distal acupoints were chosen as Hegu+Waiguan connected with electroacupuncture, sparse and dense wave 2/100 Hz was selected, and the treatment time was 60 minutes, and the intensity of the current was all to the extent that the patient could tolerate it. The needles were left in place for 60 minutes each time, once every other day, and the treatment was performed 3 times a week for 4 weeks, for a total of 12 treatments.
Experimental: Control group; Subjects in this group will be treated with oral pregabalin capsules only, 150 mg twice daily for 4 weeks.Pregabalin was administered with Lerica (specification: 75 mg*8 capsules,manufactured by Pfizer Pharmaceuticals Ltd).	Drug: Pregabalin; Subjects in this group will be treated with oral pregabalin capsules only, 150 mg twice daily for 4 weeks.Pregabalin was administered with Lerica (specification: 75 mg*8 capsules,manufactured by Pfizer Pharmaceuticals Ltd).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale/Score	This scale is performed by two trained raters to perform a Self-rating depression scale（SDS）, usually in the form of conversation and observation. After the examination, the two raters will score independently.Baseline values were taken from the pre-treatment assessment, mean values from weeks 1 and 2 of the treatment period were taken at mid-treatment (2 weeks), and mean values from weeks 3 and 4 of the treatment period were taken at the end of treatment (4 weeks). Daily mean values were taken for one month at one month follow-up and for two months at two months follow-up.	VAS will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-rating depression scale	This scale is performed by two trained raters to perform a Self-rating depression scale（SDS）, usually in the form of conversation and observation. After the examination, the two raters will score independently.	SDS will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect.
Hamilton depression scale	This scale is performed by two trained raters to perform a Hamilton depression scale (HAMD), usually in the form of conversation and observation. After the examination, the two raters will score independently.	HAMD will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect.
Pittsburgh Sleep Quality Index Scale	This scale is performed by two trained raters to perform a Pittsburgh Sleep Quality Index Scale（PSQI）, usually in the form of conversation and observation. After the examination, the two raters will score independently.	PSQI will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect.
Quality of Life Rating Scale	This scale is performed by two trained raters to perform aQuality of Life Rating Scale（SF-36）, usually in the form of conversation and observation. After the examination, the two raters will score independently.	SF-36 will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect.

Collaborators and Investigators

• Sponsor: Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: 2023ZR030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No