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

Itch; Athlete Clinical Trial

— VIBRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455036
• Other study ID #: 2017-02009
• Status: Completed
• Phase: N/A
• Start date: December 18, 2017
• Est. completion date: June 17, 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 17, 2019
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Erythema
• Itch; Athlete

Intervention

Other:
• Whole body vibration training
10 x 1 min whole body vibration exposure

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Itch intensity	0 to 10 numerical rating scale (NRS) (best score: 0 - no itch; worst score: 10)	0 months
Secondary	Erlanger atopy score	Erlanger atopy score (best score: 0 - no atopy; worst score: 100)	0 months
Secondary	Itch characteristics	measured using Eppendorf itch questionnaire	0 months
Secondary	Itch unpleasantness	0 to 10 numerical rating scale (NRS) (best score: 0 - no unpleasantness; worst score: 10)	0 months
Secondary	Skin surface temperature	assessed using a infrared thermal camera	0 months
Secondary	Erythema intensity	assessed using an erythema meter	0 months
Secondary	Total immunoglobulin E (IgE) concentration	Serum	0 months
Secondary	Tryptase concentration	serum	0 months