Analgetic Effectiveness of Acupuncture When Compared to a Standardised Analgesic Regimen in the Treatment of Herpes Zoster Neuralgia
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Alteration of pain intensity after treatment
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Sham-laser acupuncture
Sham laser acupuncture (c) is applied at equivalent points as needle acupuncture. Laser irradiation is faked.
Intervention: Sham-laser acupuncture (Device)
gabapentine
standard analgesic treatment
Intervention: gabapentine (Drug)
Acupuncture
Acupuncture treatment is semi-standardized, i.e. beside a scheme of basic points, individual points can be chosen according to the TCM diagnostic pattern.
Intervention: Acupuncture (Procedure)
Outcomes
Primary Outcomes
Alteration of pain intensity after treatment
Time Frame: 5 weeks
Secondary Outcomes
- Quantitative sensory testing(6 months)
Investigators
Dominik Irnich
PD Dr. Dominik Irnich
Ludwig-Maximilians - University of Munich