J30.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-60 2. clinical diagnosis SAR and positive skin PRICK Test or RAST Test (minimum class 2) on grasses and birch pollen for more than 2 years 2.1. mean SAR symptoms in the last season: Visual Analogue Scale (VAS) =30 mm, =70mm 2.2. mean SAR symptoms in the last 7 days: Visual Analogue Scale (VAS) =30 mm, =70mm 2.3. existence of a positive Skin-Prick-Test or RAST (minimum Class 2) 3. Given linguistic and intellectual ability to fill diaries and questionnaires 4. medical indication for intake of oral Antihistamines and / or Corticosteroids as anti-allergic treatment 5. oral and written declaration of consent
Exclusion criteria
Exclusion criteria: 1. Perennial Allergic Rhinitis or other forms of chronic Rhinitis 2. Allergic Asthma and / or mild to severe forms of Atopic Dermatitis 3. Other pulmonary disease, especially Tuberclosis 4. Autoimmune-Disease 5. Sever acute and / or chronic organic or psychatric disease 6. Medical history with anaphylactic shock 7. Intolerance of Antihistamines and / or Corticosteroids 8. specific immunotherapy / desensitizing therapy planned or carried out during study period 9. Pregnancy or nursing 10. Acupuncture treatment, acupressure and / or other complementary medicine treatments for SAR planned or carried out during study period 11. Participation in an other clinical study on SAR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Disease related quality of life (Rhinitis Quality of Life Questionnaire – RQLQ). Data to be collected in questionnaire and diary at baseline and after week 2, 4 and 8. - Intake of disease related medication (Quantity and Frequency of Rescue Medication (Cetirizin, Corticosteroid): data to be collected daily in the diary during week 1 to 4 and in week 8. - Quantity and Frequency of Rescue Medication (Cetirizin, Corticosteroid). The Rescue Medication Score of the last month is being calculated accordingly: 0-3: 0=no Cetirizin, 1 = Cetirizin 1x10mg/day, 2= Cetirizin 2x10mg/day, 3= oral Corticosteroid. | — |
Secondary
| Measure | Time frame |
|---|---|
| Data collected in intervention group and control group: - General health-related Quality of Life (SF-36) at baseline, after week 4 and week 8 - Questions on autonomic regulation (Havelhöhe trait-inventory of autonomic regulation, THKF) at baseline, after week 4 and week 8 - Days of incapacity for work due to SAR between Baseline and week 4 / week 8 - VAS symptom score nasal, non-nasal and overall symptoms on SAR between week 1-4 and in week 8 1x/week - Disease-related direct and indirect costs (social / economic perspective) Data captured only in the intervention group: - Safety of treatment: assessment of adverse events in week 1 to 4 and in week 8 - Study-doctors and Patients perception of the effectiveness of acupressure in general and related to SAR after week 4 - Satisfaction of the patient with acupressure after week 4 and after week 8 - Intensity and frequency of acupressure, data collected in a diary in week 1-4 and in week 8 - Quality control of acupressure in telephone interview or visit in week 1 and 3 - focus groups are planned within a qualitative sub-study, collecting data on patients expectations, the effect of the treatment and the patients' appreciation. | — |
Countries
Germany
Contacts
Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité – Universitätsmedizin Berlin