Herpes Zoster, Postherpetic Neuralgia, Pain
Conditions
Keywords
herpes zoster, neuropathic pain, acupuncture, randomised controlled trial, acute herpes zoster
Brief summary
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
Interventions
DEVICESham-laser acupuncture
Laser irradiation is faked, approaching a non-functioning laser pen.
DRUGgabapentine
Patients in this arm are treated individually with gabapentine 900 mg/d - 3600 mg/d, according to the recommended scheme given by the manufacturer
PROCEDUREAcupuncture
The needle acupuncture technique used in this trial is performed according the traditional way (TCM) using expendable needles.
Sponsors
Dominik Irnich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alteration of pain intensity after treatment | 5 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Quantitative sensory testing | 6 months |
Countries
Germany
Outcome results
None listed