Acupuncture in Herpes Zoster Neuralgia (ACUZoster)

Study Overview
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Brief Summary
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Symptoms that herald herpes zoster include pruritus, dysesthesia and pain along the distribution of the involved dermatome. The most distressing symptom is typically pain and the most feared complication is postherpetic neuralgia (PHN), the persistence of pain long after rash healing. PHN is defined as pain persisting more than 3 months after the rash has healed. Both, the acute pain associated with herpes zoster and the chronic pain of PHN, have multiple adverse effects on health-related quality of life. The primary objective of the trial presented is to investigate whether a 4 week semi-standardised acupuncture is non-inferior (first step) or superior (second step) to (a) the anticonvulsive drug gabapentin and (b) sham laser acupuncture in the treatment of pain associated with herpes zoster in addition to standardised analgesics. Secondary objectives include an assessment of the change of sensoric function, of long-term effectiveness, the occurrence of PHN and an evaluation of several pain specific questionnaires

Official Title
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Analgetic Effectiveness of Acupuncture When Compared to a Standardised Analgesic Regimen in the Treatment of Herpes Zoster Neuralgia

Conditions
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Herpes Zoster, Postherpetic Neuralgia, Pain

Intervention / Treatment
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* Device: Sham-laser acupuncture
* Drug: gabapentine
* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of acute HZ Pain intensity > 30 mm visual analog scale Exclusion Criteria: Patients with insulin-dependent diabetes mellitus or other diseases influencing the peripheral sensibility (e.g., polyneuropathia, chronic pain syndromes, cutaneous irritations i.e. burns) Patients under age Uncompliance Pregnancy or lactation Surgery within the last 3 month Severe heart/lung/kidney disease Diseases influencing the quality of life Psychiatric diseases (e.g., depression, schizophrenia, dementia) Chronic intake of analgesics, neuroleptics, antidepressants, corticoids, alpha-agonists Acupuncture, transdermal electric neurostimulation or other Complementary and Alternative Medicine treatment within the last 4 weeks Contraindications according to the summary of product informations against analgesic treatment (i.e., metamizol, paracetamol, tramadol, morphine) or the investigational medicinal products (gabapentine, acupuncture needles)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham-laser acupuncture<br>Sham laser acupuncture (c) is applied at equivalent points as needle acupuncture. Laser irradiation is faked. | Device: Sham-laser acupuncture<br>* Laser irradiation is faked, approaching a non-functioning laser pen.<br>|
| Active Comparator: gabapentine<br>standard analgesic treatment | Drug: gabapentine<br>* Patients in this arm are treated individually with gabapentine 900 mg/d - 3600 mg/d, according to the recommended scheme given by the manufacturer<br>|
| Active Comparator: Acupuncture<br>Acupuncture treatment is semi-standardized, i.e. beside a scheme of basic points, individual points can be chosen according to the TCM diagnostic pattern. | Procedure: Acupuncture<br>* The needle acupuncture technique used in this trial is performed according the traditional way (TCM) using expendable needles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alteration of pain intensity after treatment |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative sensory testing |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuropathic pain, acupuncture, randomised controlled trial, acute herpes zoster, herpes zoster