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Completed

NCT Number: NCT03455036

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

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

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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:

  • to determine the effect of WBV on itch rating and its unpleasantness and on skin changes.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole body vibration training

Other

10 x 1 min whole body vibration exposure

Primary outcomes

  1. Itch intensity

    Time frame: 0 months

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

Secondary outcomes

  1. Erlanger atopy score

    Time frame: 0 months

    Erlanger atopy score (best score: 0 - no atopy; worst score: 100)

  2. Itch characteristics

    Time frame: 0 months

    measured using Eppendorf itch questionnaire

  3. Itch unpleasantness

    Time frame: 0 months

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

  4. Skin surface temperature

    Time frame: 0 months

    assessed using a infrared thermal camera

  5. Erythema intensity

    Time frame: 0 months

    assessed using an erythema meter

  6. Total immunoglobulin E (IgE) concentration

    Time frame: 0 months

    Serum

  7. Tryptase concentration

    Time frame: 0 months

    serum

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: VIBRA

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 6, 2018
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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