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Electroacupuncture Therapy for Treating Postherpetic Neuralgia

Primary Purpose

Postherpetic Neuralgia

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

EA combined with medication

Medication

About this trial

This is an interventional treatment trial for Postherpetic Neuralgia focused on measuring Electroacupuncture, Postherpetic neuralgia, Pain, Randomized controlled trial, Protocol

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Acute herpes zoster, herpes zoster has not disappeared;
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.
Pregnant or lactating women;
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;
Patients have severe cognitive impairment and can not understand the study protocol;
Patients can not receive electroacupuncture treatment due to any reasons.

Sites / Locations

The Third Affiliated Hospital of Zhejiang Chinese Medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EA combined with medication group

Medication group

Arm Description

Patients in this group will receive electroacupuncture combined with gabapentin.

Participants in this group will only receive gabapentin.

Outcomes

Primary Outcome Measures

Change in sensory thresholds

Sensory thresholds is measured by quantitative sensory testing

Change in pain intensity

Pain intensity is measured by Zoster Brief Pain Inventory (ZBPI)

Secondary Outcome Measures

Change in dosage of analgetic

Dosage of analgetic

Change in score of quality of life

Quality of life is measure by 36-item Short Form Health Survey (SF-36)

Change in score of anxiety and depression severity

Anxiety and depression severity is measure by Hospital Anxiety and Depression Scale (HADS)

Change in score of sleep quality

Sleep quality is measured by Pittsburgh Sleep Quality Index (PSQI)

Adverse events

Incidence of adverse events

Full Information

NCT ID

NCT04594226

First Posted

October 11, 2020

Last Updated

January 25, 2023

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Collaborators

Lishui Hospital of Traditional Chinese Medicine, Zhejiang Provincial Tongde Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04594226

Brief Title

Electroacupuncture Therapy for Treating Postherpetic Neuralgia

Official Title

Efficacy of Electroacupuncture Therapy in Patients With Postherpetic Neuralgia: a Multicentre Randomised Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

November 11, 2020 (Actual)

Primary Completion Date

December 31, 2021 (Actual)

Study Completion Date

December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Collaborators

Lishui Hospital of Traditional Chinese Medicine, Zhejiang Provincial Tongde Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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, Pain, Randomized controlled trial, Protocol

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

132 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EA combined with medication group

Arm Type

Experimental

Arm Description

Patients in this group will receive electroacupuncture combined with gabapentin.

Arm Title

Medication group

Arm Type

Active Comparator

Arm Description

Participants in this group will only receive gabapentin.

Intervention Type

Procedure

Intervention Name(s)

EA combined with medication

Intervention Description

Primary acupoints include Ashi points, Jiaji acupoints and Xi-cleft points. Jiaji points on the ipsilateral side will be selected according to the corresponding ganglia involved by HZ. Xi-cleft points will be selected based on the distribution regions of PHN. For pain sites that mainly distributed in the gallbladder meridian, GB36 will be selected. For pain sites that mainly distributed in the stomach meridian, ST34 will be selected. For pain sites that mainly distributed in the gallbladder meridian, BL63 will be selected. For pain sites that mainly distributed in the large intestine meridian, LI7 will be selected. Supplementary acupoints will be chosen based on TCM syndrome differentiation. Operation: Two paired of acupoints are connected to the EA apparatus. EA parameter is selected as 2/100Hz wave. EA intensity is selected according to the patients' endurance. Needles will be retained and EA will last for 30 mins for each session.

Intervention Type

Drug

Intervention Name(s)

Medication

Intervention Description

The dosage of gabapentin starts from 100mg Tid. 100mg-300mg can be increased every 3-7 days and taken in three doses, but the total amount is not more than 1800mg/day. The dosage of gabapentin will be adjusted according to the patient's condition until his pain is effectively controlled. After maintaining the medication for two weeks, the dosage can be gradually reduced and 100mg can be reduced every 3-7 days.

Primary Outcome Measure Information:

Title

Change in sensory thresholds

Description

Sensory thresholds is measured by quantitative sensory testing

Time Frame

before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up

Title

Change in pain intensity

Description

Pain intensity is measured by Zoster Brief Pain Inventory (ZBPI)

Time Frame

before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up

Secondary Outcome Measure Information:

Title

Change in dosage of analgetic

Description

Dosage of analgetic

Time Frame

before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up

Title

Change in score of quality of life

Description

Quality of life is measure by 36-item Short Form Health Survey (SF-36)

Time Frame

before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up

Title

Change in score of anxiety and depression severity

Description

Anxiety and depression severity is measure by Hospital Anxiety and Depression Scale (HADS)

Time Frame

before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up

Title

Change in score of sleep quality

Description

Sleep quality is measured by Pittsburgh Sleep Quality Index (PSQI)

Time Frame

before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up

Title

Adverse events

Description

Incidence of adverse events

Time Frame

Up to 6 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients have a medical history of herpes zoster; Skin lesion has healed in the region of herpes zoster, but the duration of postherpetic neuralgia persist for more than 30 days. 20 ≤ age ≤80 years, male or female Participants can fully understand the study protocol and written informed consent is signed. Exclusion Criteria: Acute herpes zoster, herpes zoster has not disappeared; 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. Pregnant or lactating women; 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; Patients have severe cognitive impairment and can not understand the study protocol; Patients can not receive electroacupuncture treatment due to any reasons.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dexiong Han, M.D

Organizational Affiliation

The Third Affiliated hospital of Zhejiang Chinese Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Third Affiliated Hospital of Zhejiang Chinese Medical university

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29431387

Citation

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Results Reference

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PubMed Identifier

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Citation

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Citation

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Citation

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Citation

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Citation

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Electroacupuncture Therapy for Treating Postherpetic Neuralgia

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