Iliotibial Band SyndromeNCT04164316
The Effects of Kinesio Taping on Biomechanical and Clinical Outcomes in Runners With Iliotibial Band Friction Syndrome
A study testing Kinesio Tape in people with Iliotibial Band Syndrome, run by University of Central Lancashire at 2 sites in Thailand.
Trial summary
The aim of this study is to investigate the efficacy and effectiveness of the application of Kinesio Taping in the short-term management of ITBFS in an exploratory randomized control study in two patient groups, an experimental group receiving Kinesio Taping with tension, and a control group receiving Kinesio Taping… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Iliotibial Band Syndrome
- What is being tested?
- Kinesio Tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesThailand
- Study dates
- 14 Jan 2020to 1 Jan 2024
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Physical Therapy Center (Pinklao) Faculty of Physical Therapy, Mahidol University
Bangkok, 10700
Faculty of Physical Therapy, Mahidol University
Nakhon Pathom, 73170
About this study
The aim of this study is to investigate the efficacy and effectiveness of the application of Kinesio Taping in the short-term management of ITBFS in an exploratory randomized control study in two patient groups, an experimental group receiving Kinesio Taping with tension, and a control group receiving Kinesio Taping with no tension.
Read the 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.
- Conditions
- Iliotibial Band Syndrome
- Being tested
- Kinesio Tape
- Keywords
- Kinesio Taping, Biomechanics, Iliotibial Band Friction Syndrome, Clinical Outcomes
- 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.
Kinesio TapeDevice
Kinesio TexTM Tape which is the original elastic therapeutic adhesive tape which is a latex-free, hypoallergenic, waterproof, porous.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Tape No Tension | Sham comparator | Kinesio Tape No Tension Receives: Device: Kinesio Tape |
| Kinesio Tape with Tension | Active comparator | Kinesio Tape with Tension Receives: Device: Kinesio Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating scale
Numerical Pain Rating scale; pain intensity during running from 0 to10 scale where 0 = No pain and 10 = worst pain Imaginable.
Measured: one week
Pelvis, Hip, Knee, and Ankle angle.
Three-dimensional joint kinematics measurement by motion analysis capture
Measured: Immediately after the intervention
Hip, Knee, and Ankle Moments
Three-dimensional joint kinematics measurement by motion analysis capture
Measured: Immediately after the intervention
Surface Electromyography Data
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.
Measured: Immediately after the intervention
Secondary outcomes (3)
Knee Injury and Osteoarthritis Outcome Score
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.
Measured: one week
Tampa Scale for Kinesiophobia
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 ).
Measured: one week
Global Rating Of Change Scale
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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start14 Jan 2020
- Primary completion23 May 2022
- Study completion1 Jan 2024
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exploratory Randomized Control Study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University
- Responsible party
- Principal investigator, Pongchai Watcharakhueankhan, University of Central Lancashire
- Investigators
- Jim Richards, Professor, Study director, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164316
- Sponsor's protocol ID
- MU-CIRB 2019/208.2510
- Status last verified
- Jan 2025
- First submitted
- 8 Nov 2019
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be confirmed
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Kinesio Taping on Biomechanical and Clinical Outcomes in Runners With Iliotibial Band Friction Syndrome
- ClinicalTrials.gov ID
- NCT04164316
- Acronym / sponsor ID
- MU-CIRB 2019/208.2510
- Conditions
- Iliotibial Band Syndrome
- Keywords
- Kinesio Taping, Biomechanics, Iliotibial Band Friction Syndrome, Clinical Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Collaborators
- Mahidol University
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 15 Nov 2019 (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 this study is to investigate the efficacy and effectiveness of the application of Kinesio Taping in the short-term management of ITBFS in an exploratory randomized control study in two patient groups, an experimental group receiving Kinesio Taping with tension, and a control group receiving Kinesio Taping with no tension.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Exploratory Randomized Control Study
| Arm | Type | Receives |
|---|---|---|
| Kinesio Tape No Tension | Sham comparator | Device: Kinesio TapeKinesio Tape No Tension |
| Kinesio Tape with Tension | Active comparator | Device: Kinesio TapeKinesio Tape with Tension |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Kinesio TapeKinesio TexTM Tape which is the original elastic therapeutic adhesive tape which is a latex-free, hypoallergenic, waterproof, porous. | Device | Kinesio Tape No Tension, Kinesio Tape with Tension |
Primary outcome
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.
Pelvis, Hip, Knee, and Ankle angle.
Time frame: Immediately after the intervention
Three-dimensional joint kinematics measurement by motion analysis capture
Hip, Knee, and Ankle Moments
Time frame: Immediately after the intervention
Three-dimensional joint kinematics measurement by motion analysis capture
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.
3 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score
Time frame: one week
Tampa Scale for Kinesiophobia
Time frame: one week
Global Rating Of Change Scale
Time frame: one week
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 24 Jan 2025.
- Individual participant dataSharing planned: No. To be confirmed
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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.
Jim Richards, Professor study director
University of Central Lancashire
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Tape in people with Iliotibial Band Syndrome, run by University of Central Lancashire at 2 sites in Thailand.
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 4 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 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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. Some participants in this study may receive a placebo. 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?
Numerical Pain Rating scale (time frame: one week). The study lists 4 primary outcomes in all. 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 24 Jan 2025.