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CompletedNCT03455036VIBRAUpdated Jul 10, 2019

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

An interventional study of Whole body vibration training in Itch; Athlete, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-10.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
Female
01

Study 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
Read the 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.

02

Conditions studied

  • Itch; Athlete

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Keywords

  • whole body vibration, erythema, tryptase, unpleasantness
03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Whole body vibration training

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

    Other: Whole body vibration training

Interventions

  • OtherWhole body vibration training

    10 x 1 min whole body vibration exposure

05

What researchers measure

Primary outcomes

  1. Itch intensity

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

    Time frame: 0 months

Secondary outcomes

  1. Erlanger atopy score

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

    Time frame: 0 months

  2. Itch characteristics

    measured using Eppendorf itch questionnaire

    Time frame: 0 months

  3. Itch unpleasantness

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

    Time frame: 0 months

  4. Skin surface temperature

    assessed using a infrared thermal camera

    Time frame: 0 months

  5. Erythema intensity

    assessed using an erythema meter

    Time frame: 0 months

  6. Total immunoglobulin E (IgE) concentration

    Serum

    Time frame: 0 months

  7. Tryptase concentration

    serum

    Time frame: 0 months

06

Study locations

1 site
  • University Hospital Basel
    Basel, Basel Stadt 4031, Switzerland
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03455036
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Mar 6, 2018
Start date
Dec 18, 2017
Primary completion
Jan 31, 2018
Completion
Jun 17, 2019
Last update
Jul 10, 2019

Study contacts

Annegret Muendermann, PhD
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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