Pain Clinical Trial
— ACUZosterOfficial title:
Analgetic Effectiveness of Acupuncture When Compared to a Standardised Analgesic Regimen in the Treatment of Herpes Zoster Neuralgia
Verified date | August 2018 |
Source | Ludwig-Maximilians - University of Munich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 68 |
Est. completion date | April 5, 2018 |
Est. primary completion date | August 29, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Germany | Multidisciplinary Pain Unit, University of Munich | Munich | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Dominik Irnich |
Germany,
Fleckenstein J, Kramer S, Hoffrogge P, Thoma S, Lang PM, Lehmeyer L, Schober GM, Pfab F, Ring J, Weisenseel P, Schotten KJ, Mansmann U, Irnich D. Acupuncture in acute herpes zoster pain therapy (ACUZoster) - design and protocol of a randomised controlled trial. BMC Complement Altern Med. 2009 Aug 12;9:31. doi: 10.1186/1472-6882-9-31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alteration of pain intensity after treatment | 5 weeks | ||
Secondary | Quantitative sensory testing | 6 months |
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