Electroacupuncture Therapy for Treating Postherpetic Neuralgia

Not Applicable

Completed

• Conditions: Postherpetic Neuralgia
• Interventions: Procedure: EA combined with medication; Drug: Medication

• Registration Number: NCT04594226
• Lead Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University

Brief Summary

Postherpetic neuralgia (PHN) has a high incidence rate and severely impact on quality of life and health care costs, interfering with physical, emotional and social functioning of affected patients. Current therapeutic options for PHN mainly include analgetic and local anaesthesia for selective nerve blockade. Nevertheless, the efficacy of analgetic is always limited by inevitable side effects, in which patients have poor compliance. Moreover, for some most suffering patients, the control of pain is often unsatisfactory despite the administration of complex combinations. As a non-pharmarceutical therapy, acupuncture is widely use for a wide range of pain conditions. Thus, it might be an alternative treatment for PHN. The aim of this multicenter randomized controlled trial is to investigate the efficacy and safety of electroacupuncture therapy in patients with postherpetic neuralgia.

Detailed Description

This randomized controlled trial will enroll 132 patients with postherpetic neuralgia. All patients will be randomly assigned to either the EA combined with medication group or the medication group via a computerized central randomization system in a 1:1 ratio. Primary outcomes will be change in sensory thresholds and pain intensity. Secondary outcomes will be change in dosage of analgetic, quality of life, anxiety and depression severity and sleep quality.

Study Timeline

• Study First Submitted: 2020-10-11
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-20
• Study Start: 2020-11-11
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

1. Patients have a medical history of herpes zoster;
2. Skin lesion has healed in the region of herpes zoster, but the duration of postherpetic neuralgia persist for more than 30 days.
3. 20 ≤ age ≤80 years, male or female
4. Participants can fully understand the study protocol and written informed consent is signed.

Exclusion Criteria

1. Acute herpes zoster, herpes zoster has not disappeared;
2. Herpes zoster belongs to a special type, such as ophthalmic herpes zoster, auricular herpes zoster, HZ that involves internal organs, meningeal herpes zoster, and disseminated herpes zoster.
3. Pregnant or lactating women;
4. Patients have severe complications in cardiovascular, cerebrovascular, liver, kidney, hematopoietic and other systems,or have malignant tumor, mental illness, immune deficiency, hemorrhagic disorders and other diseases;
5. Patients have severe cognitive impairment and can not understand the study protocol;
6. Patients can not receive electroacupuncture treatment due to any reasons.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EA combined with medication group	EA combined with medication	Patients in this group will receive electroacupuncture combined with gabapentin.
EA combined with medication group	Medication	Patients in this group will receive electroacupuncture combined with gabapentin.
Medication group	Medication	Participants in this group will only receive gabapentin.

Primary Outcome Measures

Name	Time	Method
Change in sensory thresholds	before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up	Sensory thresholds is measured by quantitative sensory testing
Change in pain intensity	before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up	Pain intensity is measured by Zoster Brief Pain Inventory (ZBPI)

Secondary Outcome Measures

Name	Time	Method
Adverse events	Up to 6 weeks of treatment	Incidence of adverse events
Change in dosage of analgetic	before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up	Dosage of analgetic
Change in score of anxiety and depression severity	before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up	Anxiety and depression severity is measure by Hospital Anxiety and Depression Scale (HADS)
Change in score of quality of life	before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up	Quality of life is measure by 36-item Short Form Health Survey (SF-36)
Change in score of sleep quality	before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up	Sleep quality is measured by Pittsburgh Sleep Quality Index (PSQI)

Trial Locations

Locations (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical university; 🇨🇳 Hangzhou, Zhejiang, China