Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089005
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-18
First Post:
2023-10-12
Brief Title:
Home-based Treatment Using the Sidekick Tool for Pain Relief in Patients With Iliotibial Band Syndrome
Sponsor:
Hannah Antony
Organization:
Sidekick In
Study Overview
Official Title:
Home-based Instrument-assisted Soft Tissue Mobilization for Pain Relief in Patients With Iliotibial Band Syndrome A Prospective Pre-post Intervention Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to test how well the Sidekick Tool works as a home-based pain relief for iliotibial band syndrome using instrument assisted soft tissue mobilization tool in healthy participants aged 18-65 years old We hypothesize that the use of the tool over the course of seven days and by following a home-treatment plan will result in less pain that is caused by iliotibial band syndrome for the participants Pain intensity will be measured using a Numerical Pain Rating Scale from 0-to-10 Other measurements will include pain intensity after exercise and if participants return to their sport
Participants will be asked to complete an online questionnaire to ensure they are a good fit for the study Once they have been entered into the study they will complete a video call with the researchers to go gather their current pain intensity levels Participants will be emailed the instructions for how to use the tool for seven days and will be mailed the Sidekick Tool to their home
After seven days of using the tool the participants will be asked to complete a final video call to gather their pain intensity levels This number will be compared to their initial pain intensity to see if their pain has lowered while using the tool
Participants will be asked to complete an online questionnaire to ensure they are a good fit for the study Once they have been entered into the study they will complete a video call with the researchers to go gather their current pain intensity levels Participants will be emailed the instructions for how to use the tool for seven days and will be mailed the Sidekick Tool to their home
After seven days of using the tool the participants will be asked to complete a final video call to gather their pain intensity levels This number will be compared to their initial pain intensity to see if their pain has lowered while using the tool
Detailed Description:
The objective of the study is to provide evidence to support the home-based treatment of muscle scraping for iliotibial band syndrome ITBS The hypothesis of the researchers is that using the instrument assisted soft tissue mobilization IASTM tool provided by Sidekick will result in reduced pain after following a home-treatment plan for seven days The study aims to provide evidence for non-invasive treatments to reduce the healthcare costs and burden
Prior to the commencement of the study all the subjects selected signed an informed consent document as defined by the Declaration of Helsinki The sponsor is Sidekick Inc and the principal investigator is under direct employment of the sponsor
The study is a single group pre- post-test comparison following STROBE guidelines on a group of 30-40 healthy participants An incentive of 50 USD will be provided to the participants at completion of study as well the participants will get to keep the tool but are not told this
The Sidekick tool used will be the Swerve which will be mailed to participants once the eligibility questionnaire informed consent pre-test questionnaire and initial video call are completed Participants will be informed to not start new pharmacological interventions no new stretching no in-person treatments with a clinicianhealthcare professional during the seven day intervention period Participants will use a tracker to monitor use of the tool and pain responses
Participants will receive the following detailed instructions for use of the Sidekick tool
For all locations use a moderate but comfortable pressure Frequency two sessions daily morning and night Duration 3 minutes total duration in each session
Steps to complete muscle scraping on the tensor fascia latae vastus lateralis and glute muscles will all state the following steps Set a timer ready for 60s Rub the pump gel on the muscle or complete muscle scraping over tight clothing You will use the Swerve tool on the stated muscle
Fill in the Sidekick Tracker to monitor your use of the tool what time of day and sensations felt during and after completing the protocol A reminder for safety considerations including repeating contraindications and instructions on what to do if adverse events such as petechiae or ecchymosis occur during using the tool Pressure should be firm but comfortable it may produce skin redness but shouldnt produce a blanket red color if so reduce pressure or end the session on that muscle group If post-treatment bruising occurs stop the intervention until it completely heals and the skin returns to its pre-treatment color
A mid way follow up and check in via email will be conducted to ensure participants are following the protocol and to take note of any adverse reactions After seven days a final video call will be conducted and the participants will fill out the post-test questionnaire
Within-group changes from baseline will be tested with paired Students t-tests Two-sided P-values 005 were considered statistically significant All analyses will be performed in R version 412 Vienna Austria
Prior to the commencement of the study all the subjects selected signed an informed consent document as defined by the Declaration of Helsinki The sponsor is Sidekick Inc and the principal investigator is under direct employment of the sponsor
The study is a single group pre- post-test comparison following STROBE guidelines on a group of 30-40 healthy participants An incentive of 50 USD will be provided to the participants at completion of study as well the participants will get to keep the tool but are not told this
The Sidekick tool used will be the Swerve which will be mailed to participants once the eligibility questionnaire informed consent pre-test questionnaire and initial video call are completed Participants will be informed to not start new pharmacological interventions no new stretching no in-person treatments with a clinicianhealthcare professional during the seven day intervention period Participants will use a tracker to monitor use of the tool and pain responses
Participants will receive the following detailed instructions for use of the Sidekick tool
For all locations use a moderate but comfortable pressure Frequency two sessions daily morning and night Duration 3 minutes total duration in each session
Steps to complete muscle scraping on the tensor fascia latae vastus lateralis and glute muscles will all state the following steps Set a timer ready for 60s Rub the pump gel on the muscle or complete muscle scraping over tight clothing You will use the Swerve tool on the stated muscle
Fill in the Sidekick Tracker to monitor your use of the tool what time of day and sensations felt during and after completing the protocol A reminder for safety considerations including repeating contraindications and instructions on what to do if adverse events such as petechiae or ecchymosis occur during using the tool Pressure should be firm but comfortable it may produce skin redness but shouldnt produce a blanket red color if so reduce pressure or end the session on that muscle group If post-treatment bruising occurs stop the intervention until it completely heals and the skin returns to its pre-treatment color
A mid way follow up and check in via email will be conducted to ensure participants are following the protocol and to take note of any adverse reactions After seven days a final video call will be conducted and the participants will fill out the post-test questionnaire
Within-group changes from baseline will be tested with paired Students t-tests Two-sided P-values 005 were considered statistically significant All analyses will be performed in R version 412 Vienna Austria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None