Patients suffering from pain due to a herpes zoster infection MedDRA version: 8.1 Level: LLT Classification code 10019974 Term: Herpes zoster
Conditions
Interventions
Product Name: Gabapentin
Pharmaceutical Form:
INN or Proposed INN: GABAPENTIN
Route of administration of the placebo: Transdermal use
Product Name: Tramadol
Pharmaceutical Form:
INN or Proposed INN
Sponsors
Schmerzambulanz Innenstadt der LMU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria are: Pain due to an acute (30 (VAS score 0-100mm). Participance has to be voluntarily. Patients have to be of full age,with good knowledge of the german language. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria are: - age<18 or a lack of majority - all types of lacking compliance (linguistic, intellectual, motivational) - gravidity or lactation - diabetes mellitus or any other cause of polyneuropathies - acute or chronic pain syndromes apart from HZ - severe heart-, lung-, kidney-, liver disease - severe neurological disease - diseases that influence the evaluation of quality of life by their gravity - depressions, schizophrenia, dementia - severe cutaneous changes such as burns - chronic medicationwith analgesics, neuroleptics, antidepressants, corticoids, a-adrenergic blockers. - acupuncture treatment within the last 4 weeks - TENS treatment within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of the analgesic effects of acupuncture (3 treatments per week over a period of 4 weeks) to medical standard treatment (individual dosis of gabapentin with a range of 900-1800mg/d) in patients with acute herpes zoster. acupuncture treatment will be controlled with placebo laser acupuncture treatment. analgesic effects will be evaluated in regard to pain reduction according to the VAS score and opioid demand. ;Secondary Objective: Investigation of the effects of acupuncture and standard treatment on peripheral sensory via quantitative sensory testing (QST). Determination of qualitative changes in subjective and objective sense of pain and its middle-term progression. Investigation of treatment costs and frequency of post-herpetic neuralgia, as well as side effects. Influence of expectations, acupuncturist and setting will be documented.;Primary end point(s): After 4 weeks of treatment re-evaluation of pain, opioid demand, quality of life and quantitative sensory testing will take place. Participants will be interviewed regarding the developement of post-herpetic neuralgia after 6 months after inclusion in this study. Severe unwanted effects will lead to dropout. | — |
Countries
Germany
Outcome results
None listed