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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04164316
Other study ID # MU-CIRB 2019/208.2510
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 14, 2020
Est. completion date May 1, 2023

Study information

Verified date January 2023
Source University of Central Lancashire
Contact Pongchai Watcharakhueankhan, Master
Phone +44 7849226313
Email pwatcharakhueankhan@uclan.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 with no tension.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date May 1, 2023
Est. primary completion date May 23, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Kinesio Tape
Kinesio TexTM Tape which is the original elastic therapeutic adhesive tape which is a latex-free, hypoallergenic, waterproof, porous.

Locations

Country Name City State
Thailand Physical Therapy Center (Pinklao) Faculty of Physical Therapy, Mahidol University Bangkok
Thailand Faculty of Physical Therapy, Mahidol University Nakhon Pathom

Sponsors (2)

Lead Sponsor Collaborator
University of Central Lancashire Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. one week
Primary Pelvis, Hip, Knee, and Ankle angle. Three-dimensional joint kinematics measurement by motion analysis capture Immediately after the intervention
Primary Hip, Knee, and Ankle Moments Three-dimensional joint kinematics measurement by motion analysis capture Immediately after the intervention
Primary 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. Immediately after the intervention
Secondary 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. one week
Secondary 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 ). one week
Secondary 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. one week
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