Acupuncture in Herpes Zoster Neuralgia (ACUZoster)

Pain Clinical Trial

— ACUZoster  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885586
• Other study ID #: AcuZoster Effectiveness 2006
• Status: Completed
• Phase: Phase 4
• Start date: November 2008
• Est. completion date: April 5, 2018

Study information

• Verified date: August 2018
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Herpes Zoster
• Neuralgia
• Neuralgia, Postherpetic
• Pain
• Postherpetic Neuralgia

Intervention

Device:
• Sham-laser acupuncture
Laser irradiation is faked, approaching a non-functioning laser pen.

Drug:
• gabapentine
Patients in this arm are treated individually with gabapentine 900 mg/d - 3600 mg/d, according to the recommended scheme given by the manufacturer

Procedure:
• Acupuncture
The needle acupuncture technique used in this trial is performed according the traditional way (TCM) using expendable needles.

Locations

Country	Name	City	State
Germany	Multidisciplinary Pain Unit, University of Munich	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Dominik Irnich

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alteration of pain intensity after treatment		5 weeks
Secondary	Quantitative sensory testing		6 months