Untersuchung der analgetischen Wirkung der AKupunktur bei Patienten mit Herpes zoster im Vergleich mit einer medikamentösen Standardtherapie- Comparison of acupuncture treatment to medical standard therapy in patients with acute herpes zoster - Wirksamkeit von Akupunktur bei Herpes zoster

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2007
INTERVENTION: 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: TRAMADOL HYDROCHLORIDE Product Name: Metamizol Product Code: Metamizol Pharmaceutical Form: INN or Proposed INN: METAMIZOLE SODIUM Product Name: paracetamol Pharmaceutical Form: INN or Proposed INN: PARACETAMOL Product Name: Morphin Pharmaceutical Form: INN or Proposed INN: Morphin CONDITION: Patients suffering from pain due to a herpes zoster infection ; MedDRA version: 8.1 Level: LLT Classification code 10019974 Term: Herpes zoster PRIMARY OUTCOME: 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. 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. 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. INCLUSION CRITERIA: Inclusion criteria are: Pain due to an acute (<3 months) herpes zoster infection with an intensity >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
Epistemonikos ID: 993738f37c8b949df6202f322d52c4102f0a17e2
First added on: Aug 21, 2024