Home-based Treatment Using the Sidekick Tool for Pain Relief in Patients With Iliotibial Band Syndrome
Home-based Instrument-assisted Soft Tissue Mobilization for Pain Relief in Patients With Iliotibial Band Syndrome: A Prospective, Pre-post Intervention Study
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2023
CompletedFirst Posted
Study publicly available on registry
October 18, 2023
CompletedStudy Start
First participant enrolled
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 24, 2023
CompletedOctober 18, 2023
October 1, 2023
1 month
October 12, 2023
October 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain intensity during the day
Numerical pain rating scale 0-to-10
Day 0, Day 7
Secondary Outcomes (3)
Pain intensity after exercise
Day 0, Day 7
Return to sport
Day 0, day 7
Number of participants with adverse effects after use of intervention
Day 0, Day 7
Study Arms (1)
Intervention Group
EXPERIMENTALdaily use of the IASTM on the hip, quad and glute muscles for 60s in duration each session
Interventions
Application of IASTM tool on specific muscle areas twice daily for intervention protocol of 7 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hannah Antonylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- No masking
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Product Education Lead
Study Record Dates
First Submitted
October 12, 2023
First Posted
October 18, 2023
Study Start
October 23, 2023
Primary Completion
November 24, 2023
Study Completion
November 24, 2023
Last Updated
October 18, 2023
Record last verified: 2023-10