Itch; AthleteVIBRANCT03455036
The Mysterious on/Off Itch and Erythema During Whole Body Vibration Exercise
A study testing Whole body vibration training in people with Itch; Athlete, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Itch; Athlete
- What is being tested?
- Whole body vibration training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Dec 2017to 17 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-35 years
- female
- Informed Consent as documented by signature (Appendix Informed Consent Form)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
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:
- To determine the effect of WBV on itch rating and its unpleasantness and on skin changes.
- 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:
- 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.
- Conditions
- Itch; Athlete
- Being tested
- Whole body vibration training
- Keywords
- whole body vibration, erythema, tryptase, unpleasantness
- Medical subject headings
- Pruritus, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibration trainingOther
10 x 1 min whole body vibration exposure
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration training | Experimental | Healthy female subjects complete whole body vibration training (10 x 1 min exposure) Receives: Other: Whole body vibration training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Itch intensity
0 to 10 numerical rating scale (NRS) (best score: 0 - no itch; worst score: 10)
Measured: 0 months
Secondary outcomes (7)
Erlanger atopy score
Erlanger atopy score (best score: 0 - no atopy; worst score: 100)
Measured: 0 months
Itch characteristics
measured using Eppendorf itch questionnaire
Measured: 0 months
Itch unpleasantness
0 to 10 numerical rating scale (NRS) (best score: 0 - no unpleasantness; worst score: 10)
Measured: 0 months
Skin surface temperature
assessed using a infrared thermal camera
Measured: 0 months
Erythema intensity
assessed using an erythema meter
Measured: 0 months
Total immunoglobulin E (IgE) concentration
Serum
Measured: 0 months
Tryptase concentration
serum
Measured: 0 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start18 Dec 2017
- Primary completion31 Jan 2018
- Study completion17 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Itch; AthleteStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The design of the study is a single-centre cross-sectional single-arm intervention study.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annegret Muendermann, PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455036
- Sponsor's protocol ID
- 2017-02009
- Other IDs
- 2017
- Acronym
- VIBRA
- Status last verified
- Jul 2019
- First submitted
- 27 Feb 2018
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mysterious on/Off Itch and Erythema During Whole Body Vibration Exercise
- ClinicalTrials.gov ID
- NCT03455036
- Acronym / sponsor ID
- VIBRA / 2017-02009
- Conditions
- Itch; Athlete
- Keywords
- whole body vibration, erythema, tryptase, unpleasantness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the effect of WBV on itch rating and its unpleasantness and on skin changes.
- 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:
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The design of the study is a single-centre cross-sectional single-arm intervention study.
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration training | Experimental | Other: Whole body vibration trainingHealthy female subjects complete whole body vibration training (10 x 1 min exposure) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18-35 years
- female
- Informed Consent as documented by signature (Appendix Informed Consent Form)
Key exclusion criteria (8 listed)
- itchy skin diseases
- hay fever
- asthma
- chronic venous insufficiency
- peripheral artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body vibration training10 x 1 min whole body vibration exposure | Other | Whole body vibration training |
Primary outcome
Itch intensity
Time frame: 0 months
0 to 10 numerical rating scale (NRS) (best score: 0 - no itch; worst score: 10)
7 secondary outcomes
Erlanger atopy score
Time frame: 0 months
Itch characteristics
Time frame: 0 months
Itch unpleasantness
Time frame: 0 months
Skin surface temperature
Time frame: 0 months
Erythema intensity
Time frame: 0 months
Total immunoglobulin E (IgE) concentration
Time frame: 0 months
Tryptase concentration
Time frame: 0 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annegret Muendermann, PhD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body vibration training in people with Itch; Athlete, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Itch intensity (time frame: 0 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.