- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04164316
The Effects of Kinesio Taping on Biomechanical and Clinical Outcomes in Runners With Iliotibial Band Friction Syndrome
Study Overview
Detailed Description
To determine the immediate effects of taping on the three-dimensional joint kinematics and moments of the lower limb during running in ITBFS patients, and to determine any differences between the experimental and control groups.
To determine the immediate effects of taping on muscle activity of the gluteus maximus, gluteus medius, tensor fascia lata, vastus medialis, and vastus lateralis in ITBFS patients, and to determine any differences between the experimental and control groups.
To determine if the short-term perceptions of pain, symptoms, ADL function, sport and recreation function, quality of Life, and fear of movement are changed with taping, and to determine any differences between the experimental and control groups.
To determine any perceived changes in the stability of the knee joint, comfort and benefits with taping, and to determine any differences between the experimental and control groups.
To determine if muscle strength, muscle length, and functional movement are changed with taping, and to determine any differences between the experimental and control groups.
To explore the relationship between the clinical and biomechanical outcome measures in ITBFS patients.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pongchai Watcharakhueankhan, Master
- Phone Number: +44 7849226313
- Email: pwatcharakhueankhan@uclan.ac.uk
Study Locations
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-
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Bangkok, Thailand, 10700
- Recruiting
- Physical Therapy Center (Pinklao) Faculty of Physical Therapy, Mahidol University
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Contact:
- Physical Therapy Center (Pinklao) Faculty of Physical Therapy,
- Phone Number: 20605 (+66)2-441-5450
- Email: komsak.sin@mahidol.ac.th
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Principal Investigator:
- Pongchai Watcharakhueankhan, Master
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Nakhon Pathom, Thailand, 73170
- Recruiting
- Faculty of Physical Therapy, Mahidol University
-
Principal Investigator:
- Pongchai Watcharakhueankhan, Master
-
Contact:
- Faculty of Physical Therapy, Mahidol University
- Phone Number: 20605 (+66)2-441-5450
- Email: komsak.sin@mahidol.ac.th
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged between 18 to 45 years
- Regularly run a minimum of 10 kilometres a week,
- Current symptoms of ITBFS, assessed using the Noble compression test and Ober's test, and pain at lateral femoral condyle during running
Exclusion Criteria:
- History of taking any analgesic or anti-inflammatory drugs for 72 hours prior to testing.
- Previous surgery to the lower limbs,
- Skin allergy to kinesio tape,
- Signs or symptoms of other knee pathologies including; patellofemoral pain, knee joint osteoarthritis, lateral meniscus injury, common peroneal nerve injury, refer pain from lumbar spine, superior tibiofibular joint sprain, and popliteus or bicep femoris tendinitis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Kinesio Tape No Tension
|
Kinesio TexTM Tape which is the original elastic therapeutic adhesive tape which is a latex-free, hypoallergenic, waterproof, porous.
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Active Comparator: Kinesio Tape with Tension
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Kinesio TexTM Tape which is the original elastic therapeutic adhesive tape which is a latex-free, hypoallergenic, waterproof, porous.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Pain Rating scale
Time Frame: one week
|
Numerical Pain Rating scale; pain intensity during running from 0 to10 scale where 0 = No pain and 10 = worst pain Imaginable.
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one week
|
Pelvis, Hip, Knee, and Ankle angle.
Time Frame: Immediately after the intervention
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Three-dimensional joint kinematics measurement by motion analysis capture
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Immediately after the intervention
|
Hip, Knee, and Ankle Moments
Time Frame: Immediately after the intervention
|
Three-dimensional joint kinematics measurement by motion analysis capture
|
Immediately after the intervention
|
Surface Electromyography Data
Time Frame: Immediately after the intervention
|
Five Surface Electromyography electrodes were placed over the gluteus maximus (Gmax), gluteus medius (Gmed), tensor fascia latae (TFL), vastus medialis (VM), vastus lateralis (VL) muscles to measure muscle activity.
|
Immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee Injury and Osteoarthritis Outcome Score
Time Frame: one week
|
The Knee Injury and Osteoarthritis Outcome Score's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items).
A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
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one week
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Tampa Scale for Kinesiophobia
Time Frame: one week
|
The Tampa Scale for Kinesiophobia is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement.
A Likert scale is used and all items have four possible answer options scored from 1 (strongly disagree ) to 4 (strongly agree ).
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one week
|
Global Rating Of Change Scale
Time Frame: one week
|
Global rating of change (GRC) scales are very commonly used in clinical research, particularly in the musculoskeletal area.
the overall condition of your injured body part or region.
Rating from -7 A very great deal worse to +7 scale (A very great deal better) from the begin intervention time until now.
|
one week
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Jim Richards, Professor, University of Central Lancashire
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MU-CIRB 2019/208.2510
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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