Electroacupuncture Therapy for Treating Postherpetic Neuralgia

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04594226

Collaborator

Lishui Hospital of Traditional Chinese Medicine (Other), Zhejiang Provincial Tongde Hospital (Other)

132

Enrollment

Location

Arms

12.6

Anticipated Duration (Months)

10.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postherpetic Neuralgia	Procedure: EA combined with medication Drug: Medication	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 11, 2020

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EA combined with medication group Patients in this group will receive electroacupuncture combined with gabapentin.	Procedure: EA combined with medication 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. Drug: Medication 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.
Active Comparator: Medication group Participants in this group will only receive gabapentin.	Drug: Medication 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.

Arm

Intervention/Treatment

Experimental: EA combined with medication group

Patients in this group will receive electroacupuncture combined with gabapentin.

Procedure: EA combined with medication

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.

Drug: Medication

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.

Active Comparator: Medication group

Participants in this group will only receive gabapentin.

Drug: Medication

Outcome Measures

Primary Outcome Measures

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

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 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 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 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)
Adverse events [Up to 6 weeks of treatment]
Incidence of adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.