Systemic Sclerosis
Conditions
Brief summary
The objectives of this prospective crossover, open-label, nonrandomized study are to estimate effect sizes of vasodilatation and sense of warmth after application of topical rosemary essential oil in patients suffering from systemic sclerosis.
Detailed description
In a crossover design, patients suffering from systemic sclerosis (12 subjects) receive applications of olive oil and of 10% Rosmarinus officinalis L. (rosemary) essential oil to both hands with a wash-out period of 3 hours. Effects on vasodilatation are measured with infrared thermography. Patients' sense of warmth is assessed by the Herdecke warmth perception questionnaire. Measurements take place at baseline and 45 minutes following the interventions (pre-post-comparison). To determine within and between-differences, 2-sample t-tests will be used and effect sizes will be calculated (Standardized Effect Size).
Interventions
OTHERPlacebo
Topically-applied oil to both dorsal and palmar aspects of the hands
OTHERRosemary essential oil
Topically-applied oil to both dorsal and palmar aspects of the hands
Sponsors
University Hospital Tuebingen
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Systemic sclerosis with skin involvement of hands and fingers * Raynaud phenomenon with frequent symptoms of cold hands
Exclusion criteria
* Topical treatment with nitroglyceride * Lymphdrainage \< 24 hours * Other topical treatment of hands and arms \< 4 hours prior to study intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in temperature at the fingers | baseline and 45 minutes after the intervention | Distal skin temperature in °C measured at the fingers with a high-definition infrared camera (FLIR-Systems, type SC660) before and 45 minutes following the oil application |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in temperature at the back of the hands | baseline and 45 minutes after the intervention | Distal skin temperature in °C measured at the back of the hands with a high-definition infrared camera (FLIR-Systems, type SC660) before and 45 minutes following the oil application |
| Change from baseline in temperature at the forearms | baseline and 45 minutes after the intervention | Distal skin temperature in °C measured at the forearms with a high-definition infrared camera (FLIR-Systems, type SC660) before and 45 minutes following the oil application |
| Change from baseline of Herdecke warmth perception questionnaire (HeWEF) | baseline and 45 minutes after the intervention | Patients' sense of warmth in different body regions as well as overall warmth assessed before and 45 minutes following the oil application |
| Scleroderma Health Assessment Questionnaire (SHAQ) | baseline | Questionnaire with 8 sections: e.g. dressing, arising, eating, walking,hygiene, etc... with 2 or 3 questions for each section. Scoring within each section is from0 (without any difficulty) to 3 (unable to do). |
| Rodnan skin score of the hands | baseline | Skin score to assess the clinical severity of systemic scleroderma. 17 body areas are assessed by clinical palpation. The examiner assesses the skin thickness using a 4-point scale:0 = normal thickness, 1 = weak skin thickening, 2 = moderate skin thickening, 3 = severe skin thickening. |
Countries
Germany
Outcome results
None listed