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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham-laser acupuncture | Sham Comparator | Sham laser acupuncture (c) is applied at equivalent points as needle acupuncture. Laser irradiation is faked. |
|
| gabapentine | Active Comparator | standard analgesic treatment |
|
| Acupuncture | Active Comparator | Acupuncture treatment is semi-standardized, i.e. beside a scheme of basic points, individual points can be chosen according to the TCM diagnostic pattern. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham-laser acupuncture | Device | Laser irradiation is faked, approaching a non-functioning laser pen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alteration of pain intensity after treatment | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative sensory testing | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multidisciplinary Pain Unit, University of Munich | Munich | Bavaria | 80336 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19674449 | Background | 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. |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D051474 | Neuralgia, Postherpetic |
| D010146 | Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| gabapentine | Drug | Patients in this arm are treated individually with gabapentine 900 mg/d - 3600 mg/d, according to the recommended scheme given by the manufacturer |
|
| Acupuncture | Procedure | The needle acupuncture technique used in this trial is performed according the traditional way (TCM) using expendable needles. |
|
| D007239 | Infections |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |