Clinical trial NCT03455036: The Mysterious on/Off Itch and Erythema During Whole Body Vibration Exercise
Official title: The Mysterious on/Off Itch and Erythema During Whole Body Vibration Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Itch; Athlete
Keywords: whole body vibration, erythema, tryptase, unpleasantness
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The design of the study is a single-centre cross-sectional single-arm intervention study.
Primary purpose: BASIC_SCIENCE

Brief summary: Intense itch on the legs sometimes associated with redness can be adverse effects of whole body vibration (WBV) according to own observations and numerous posts in non-professional online-blogs. To the investigators' knowledge, the appearance of itch and/or a rash during WBV exercise has not yet been described.

The research objectives are:

1. To determine the effect of WBV on itch rating and its unpleasantness and on skin changes.
2. To determine the effect of WBV on immunoglobulin E (IgE) and serum tryptase

Detailed description: Objectives Intense itch on the legs sometimes associated with redness can be adverse effects of WBV according to the investigators observations and numerous posts in non-professional online-blogs. To the investigators knowledge, the appearance of itch and/or a rash during WBV exercise has not yet been described.

The objectives of this study are:

1. to determine the effect of WBV on itch rating and its unpleasantness and on skin changes.
2. to determine the effect of WBV on serum tryptase.

Hypothesis The working hypothesis is that repeated WBV leads to an increase of itching and erythema. Further investigators hypothesize that repeated WBV does not lead to an increase in serum tryptase.

Inclusion and exclusion criteria will be evaluated. Subjects will be instructed to not shave their legs one week before the intervention day and to shave only the left leg from the ankle to the knee on the day prior to the intervention day.

On the intervention day, subjects will be informed in detail about the study protocol and written informed consent will be collected. If a pregnancy cannot be excluded (days from last menstruation) subjects are instructed to do a pregnancy test. Then, a blood sample will be taken. Subsequently, subjects will be instructed to stand on the vibration plate (Galileo 900) in a slightly crouched position with their hands loosely resting on the rail. Subjects will complete ten 1-minute WBV repetitions interspaced by 1-minute breaks in seated position. During each break, subjects will rate the itch intensity, and skin changes will be captured. Sixty minutes after the last WBV repetition, another blood sample will be taken. Subjects will rest until itch and erythema return to baseline. During resting phase subjects will fill in the Eppendorf itch questionnaire and the Erlanger atopy score.

Eligibility criteria: Inclusion Criteria:

* age 18-35 years
* female
* Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion Criteria:

* itchy skin diseases
* hay fever
* asthma
* chronic venous insufficiency
* peripheral artery disease
* musculoskeletal diseases or injuries affecting the legs, hips and pelvis
* BMI \< 17 and \> 35 kg/m2
* pregnancy

Primary outcomes:
measure: Itch intensity
timeFrame: 0 months
Secondary outcomes:
measure: Erlanger atopy score
timeFrame: 0 months
measure: Itch characteristics
timeFrame: 0 months
measure: Itch unpleasantness
timeFrame: 0 months
measure: Skin surface temperature
timeFrame: 0 months
measure: Erythema intensity
timeFrame: 0 months
measure: Total immunoglobulin E (IgE) concentration
timeFrame: 0 months
measure: Tryptase concentration
timeFrame: 0 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Annegret Muendermann, PhD
role: PRINCIPAL_INVESTIGATOR
References: