The Treatment of Postherpetic Neuralgia in the Head and Face With Superficial Needling Combined With Electroacupuncture

NCT06420778 | Recruiting

• 1 other identifier: 2023ZR030
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postherpetic Neuralgia; Electroacupuncture; Infrared Thermography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Self-rating depression scale

  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

  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

  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

  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.

Study Arms (2)

therapy group

EXPERIMENTAL

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

Control group

EXPERIMENTAL

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

Interventions

electroacupuncture OTHER

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.

therapy group

Pregabalin DRUG

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).

Control group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the diagnostic criteria in the 2016 Chinese Expert Consensus on the Diagnosis and Treatment of Postherpetic Neuralgia; Age 50-80 years (including telangiectasia), gender is not limited; 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; Be conscious and have a clear sense of pain and discriminative ability; 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.

Sponsors & Collaborators

• Zhejiang Chinese Medical University: lead

Study Sites (1)

Xiaoyu Li

Hangzhou, Zhejiang, 310053, China

RECRUITING

Related Publications (1)

• Qiu P, Sun H, Xia Y, Qu S, Fang J, Li X. The efficacy of electroacupuncture for postherpetic neuralgia arising from herpes zoster affecting the cephalo-facial area: study protocol for a double center randomized controlled trial. Front Med (Lausanne). 2025 Aug 28;12:1616035. doi: 10.3389/fmed.2025.1616035. eCollection 2025.

  PMID: 40950954 DERIVED

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Electroacupuncture; Pregabalin

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Xiaoyu Li

CONTACT

+8618758240921; 673426608@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: July 12, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 6, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)