Iliotibial Band SyndromeNCT06089005
Home-based Treatment Using the Sidekick Tool for Pain Relief in Patients With Iliotibial Band Syndrome
A study testing Instrument Assisted Soft Tissue Mobilization device in people with Iliotibial Band Syndrome, run by Hannah Antony.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Iliotibial Band Syndrome
- What is being tested?
- Instrument Assisted Soft Tissue Mobilization device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 23 Oct 2023to 24 Nov 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosed (have them enter the month of diagnosis) by a physician or physical therapist
- pain on lateral side of knee
- tenderness on palpation at lateral knee
- unilateral symptoms only
- past treatments can include rolling, stretching
- pain duration of 3-12 weeks
Who cannot join
- bilateral symptoms
- no diagnosis
- other knee pain conditions
- prior surgeries of the lower limb
- current pharmacological treatments
- Any contraindications including:
- open wounds or unhealed sites Thrombophlebitis uncontrolled hypertension or high blood pressure skin infections Current hematoma myositis ossificans Boney fractures high pain sensation acute inflammatory conditions congestive heart disease circulatory disorders Osteoporosis Cancer Pregnancy Type 1 diabetes Type 2 diabetes varicose veins kidney dysfunction rheumatoid arthritis Lymphedema chronic regional pain syndrome Current use of steroidal medications Current use of anticoagulant medications Current use of NSAID medications (non-steroidal anti-inflammatory drugs)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Home-based Instrument-assisted Soft Tissue Mobilization for Pain Relief in Patients With Iliotibial Band Syndrome: A Prospective, Pre-post Intervention Study
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.
Read the 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 clinician/healthcare 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 shouldn't 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 it's 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 Student's t-tests. Two-sided P-values < 0.05 were considered statistically significant. All analyses will be performed in R (version 4.1.2, Vienna, Austria).
- Conditions
- Iliotibial Band Syndrome
- Being tested
- Instrument Assisted Soft Tissue Mobilization device
- Keywords
- Iliotibial band friction syndrome, Iliotibial band pain
- Medical subject headings
- Iliotibial Band Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted Soft Tissue Mobilization deviceDevice
Application of IASTM tool on specific muscle areas twice daily for intervention protocol of 7 days
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | daily use of the IASTM on the hip, quad and glute muscles for 60s in duration each session Receives: Device: Instrument Assisted Soft Tissue Mobilization device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity during the day
Numerical pain rating scale 0-to-10
Measured: Day 0, Day 7
Secondary outcomes (3)
Pain intensity after exercise
Numerical pain rating scale 0-to-10
Measured: Day 0, Day 7
Return to sport
Yes, no binary option participant count
Measured: Day 0, day 7
Number of participants with adverse effects after use of intervention
Yes, no binary option participant count
Measured: Day 0, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start23 Oct 2023 (estimated)
- Primary completion24 Nov 2023 (estimated)
- Study completion24 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliotibial Band SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pre post test single group intervention study design
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannah Antony
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Hannah Antony, Sidekick In
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089005
- Sponsor's protocol ID
- SIDEKICK101002
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Instrument-assisted Soft Tissue Mobilization for Pain Relief in Patients With Iliotibial Band Syndrome: A Prospective, Pre-post Intervention Study
- ClinicalTrials.gov ID
- NCT06089005
- Acronym / sponsor ID
- SIDEKICK101002
- Conditions
- Iliotibial Band Syndrome
- Keywords
- Iliotibial band friction syndrome, Iliotibial band pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hannah AntonyIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2023 (estimated)
- Primary completion
- 24 Nov 2023 (estimated)
- Study completion
- 24 Nov 2023 (estimated)
- First posted
- 18 Oct 2023 (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.
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.
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 clinician/healthcare 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 shouldn't 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 it's 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 Student's t-tests. Two-sided P-values < 0.05 were considered statistically significant. All analyses will be performed in R (version 4.1.2, Vienna, Austria).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pre post test single group intervention study design
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Instrument Assisted Soft Tissue Mobilization devicedaily use of the IASTM on the hip, quad and glute muscles for 60s in duration each session |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosed (have them enter the month of diagnosis) by a physician or physical therapist
- pain on lateral side of knee
- tenderness on palpation at lateral knee
- unilateral symptoms only
- past treatments can include rolling, stretching
Key exclusion criteria (7 listed)
- bilateral symptoms
- no diagnosis
- other knee pain conditions
- prior surgeries of the lower limb
- current pharmacological treatments
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 |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilization deviceApplication of IASTM tool on specific muscle areas twice daily for intervention protocol of 7 days | Device | Intervention Group |
Primary outcome
Pain intensity during the day
Time frame: Day 0, Day 7
Numerical pain rating scale 0-to-10
3 secondary outcomes
Pain intensity after exercise
Time frame: Day 0, Day 7
Return to sport
Time frame: Day 0, day 7
Number of participants with adverse effects after use of intervention
Time frame: Day 0, Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument Assisted Soft Tissue Mobilization device in people with Iliotibial Band Syndrome, run by Hannah Antony.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannah Antony (1-877-897-5425, hannah@sidekicktool.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity during the day (time frame: Day 0, Day 7). 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 18 Oct 2023.