Atopic dermatitis, Neurodermatitis L20
Conditions
Interventions
Group 1: Intervention group 1 Osteopathy:
5 treatments with osteopathy with a respective treatment duration of approx. 45 minutes, at a distance of about 2 weeks
Group 2: Intervention group 2 Acupunct
Sponsors
Institut fu¨r Sozialmedizin, Epidemiologie und Gesundheitso¨konomie, Charite´ – Universita¨tsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • Age between 18 and 65 years • Men and women • Presence of the confirmed diagnosis "Atopic dermatitis" • Symptoms of AD for at least 6 months • at least 3 out of 4 criteria for AD to Williams • Three Item Severity Score - TIS from 2 to 7 • Average itching of the haemorrhages between 40 and 80 mm on a VAS (0-100 mm) within the last 7 days before study inclusion • Consentability and the existence of a written declaration of consent.
Exclusion criteria
Exclusion criteria: • Presence of another dermatosis • Ingestion of systemic, oral and / or intravenous corticosteroids in the last 3 months (local steroids could be used) • Use of other systemic medications for the treatment of AD, especially immune modulators or calcineurin inhibitors • Treatment of AD with osteopathy or acupuncture within the last 3 months before the start of the study • Psychotherapy within the last 3 months or is planned in the next 12 months • Additional alternative and / or complementary medicine within the last 6 weeks or is planned for the next 12 months • Additional use of therapies that have a positive effect on the symptoms of an AD - e.g. Hyposensitization within the last 4 weeks or is planned in the next 12 months • Presence or suspicion of primary or secondary malignant tumors • Rheumatic disease • Obesity with BMI> 30 kg / m² • Presence of pregnancy or breastfeeding • The presence of a severe acute and / or chronic organic or mental illness which does not allow participation in the therapy • Other mental or somatic disorders that do not allow participation in the therapy • Drug and / or alcohol abuse • Insufficient knowledge of the German language • Participation in an intervention study during the same period of the study or in the last 6 months before the start of the study • Existing pension procedure or planned initiation of a pension scheme (disease-related early retirement)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exploratory study Measurement times: Baseline, 6, 12, 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome parameters at baseline and after 6, 12 and 26 weeks: • Assessment of the mean subjectively perceived itching on the visual analog scale (VAS, 0-100mm) • Number of applications of topical corticosteroids (subdivision in classes 1 to 3) within the last 7 days • General health-related quality of life (SF-12) • Dermatology Life Quality Index (DLQI); • days of incapacity for work due to AD retrospectively for the period 3 months before the start of the study and the study period • Disease-specific resource utilization retrospectively for the period 3 months before the beginning of the study and the study period (number of doctor's visits, hospital stays, medication use, • Disease-specific direct and indirect costs retrospectively for the period 3 months before the start of the study and the study period (societal perspective), cost-effectiveness against the control group • Therapeutic safety by detecting adverse events Target parameters at baseline and after 12 and 26 weeks: • Severity of AD after scoring Atopic dermatitis (SCORAD) index Eczema Area and Severity Index (EASI) In addition, the expectations and the efficacy expectation regarding the study interventions of the therapist and the participant side as well as the satisfaction of the participants are raised. The participants receive a questionnaire at Baseline as well as after 6, 12 and 26 weeks. In a diary, the symptoms of AD are documented by visual analogue scales for itching and sleep disturbance as well as the application of the medication for the AD in the form of local corticosteroids in the first 12 weeks by the study participants. | — |
Countries
Germany
Contacts
Public ContactMargit Cree
Institut f. Sozialmedizin, Epidemiologie u. Gesundheitsökonomie, Charité - Universitätsmedizin Berlin
Outcome results
None listed