Clinical trial NCT04594226: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postherpetic Neuralgia
Keywords: Electroacupuncture
Postherpetic neuralgia
Pain
Randomized controlled trial
Protocol
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
Collaborators: name: Lishui Hospital of Traditional Chinese Medicine
name: Zhejiang Provincial Tongde Hospital
First posted: 2020-10-20
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in sensory thresholds
timeFrame: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
measure: Change in pain intensity
timeFrame: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Secondary outcomes:
measure: Change in dosage of analgetic
timeFrame: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
measure: Change in score of quality of life
timeFrame: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
measure: Change in score of anxiety and depression severity
timeFrame: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
measure: Change in score of sleep quality
timeFrame: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
measure: Adverse events
timeFrame: Up to 6 weeks of treatment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical university
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Dexiong Han, M.D
role: PRINCIPAL_INVESTIGATOR
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