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Clinical Trials/NCT03455036
NCT03455036CompletedNot Applicable

The Mysterious on/Off Itch and Erythema During Whole Body Vibration Exercise

University Hospital, Basel, Switzerland1 site in 1 country20 target enrollmentStarted: December 18, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Itch intensity

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Whole body vibration training

Experimental

Healthy female subjects complete whole body vibration training (10 x 1 min exposure)

Intervention: Whole body vibration training (Other)

Outcomes

Primary Outcomes

Itch intensity

Time Frame: 0 months

0 to 10 numerical rating scale (NRS) (best score: 0 - no itch; worst score: 10)

Secondary Outcomes

  • Itch characteristics(0 months)
  • Skin surface temperature(0 months)
  • Itch unpleasantness(0 months)
  • Erlanger atopy score(0 months)
  • Erythema intensity(0 months)
  • Total immunoglobulin E (IgE) concentration(0 months)
  • Tryptase concentration(0 months)

Investigators

Sponsor
University Hospital, Basel, Switzerland
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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