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The Effects of Kinesio Taping on Biomechanical and Clinical Outcomes in Runners With Iliotibial Band Friction Syndrome

Primary Purpose

Iliotibial Band Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Kinesio Tape
Sponsored by
University of Central Lancashire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iliotibial Band Syndrome focused on measuring Kinesio Taping, Biomechanics, Iliotibial Band Friction Syndrome, Clinical Outcomes

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Physical Therapy Center (Pinklao) Faculty of Physical Therapy, Mahidol UniversityRecruiting
  • Faculty of Physical Therapy, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Kinesio Tape No Tension

Kinesio Tape with Tension

Arm Description

Kinesio Tape No Tension

Kinesio Tape with Tension

Outcomes

Primary Outcome Measures

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.
Pelvis, Hip, Knee, and Ankle angle.
Three-dimensional joint kinematics measurement by motion analysis capture
Hip, Knee, and Ankle Moments
Three-dimensional joint kinematics measurement by motion analysis capture
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.

Secondary Outcome Measures

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.
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 ).
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.

Full Information

First Posted
November 8, 2019
Last Updated
January 12, 2023
Sponsor
University of Central Lancashire
Collaborators
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04164316
Brief Title
The Effects of Kinesio Taping on Biomechanical and Clinical Outcomes in Runners With Iliotibial Band Friction Syndrome
Official Title
The Effects of Kinesio Taping on Biomechanical and Clinical Outcomes in Runners With Iliotibial Band Friction Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
May 23, 2022 (Actual)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Central Lancashire
Collaborators
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iliotibial Band Syndrome
Keywords
Kinesio Taping, Biomechanics, Iliotibial Band Friction Syndrome, Clinical Outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Exploratory Randomized Control Study
Masking
None (Open Label)
Masking Description
This is using Kinesio Tape which is difficult to blind the patients and clinicians.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kinesio Tape No Tension
Arm Type
Sham Comparator
Arm Description
Kinesio Tape No Tension
Arm Title
Kinesio Tape with Tension
Arm Type
Active Comparator
Arm Description
Kinesio Tape with Tension
Intervention Type
Device
Intervention Name(s)
Kinesio Tape
Intervention Description
Kinesio TexTM Tape which is the original elastic therapeutic adhesive tape which is a latex-free, hypoallergenic, waterproof, porous.
Primary Outcome Measure Information:
Title
Numerical Pain Rating scale
Description
Numerical Pain Rating scale; pain intensity during running from 0 to10 scale where 0 = No pain and 10 = worst pain Imaginable.
Time Frame
one week
Title
Pelvis, Hip, Knee, and Ankle angle.
Description
Three-dimensional joint kinematics measurement by motion analysis capture
Time Frame
Immediately after the intervention
Title
Hip, Knee, and Ankle Moments
Description
Three-dimensional joint kinematics measurement by motion analysis capture
Time Frame
Immediately after the intervention
Title
Surface Electromyography Data
Description
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.
Time Frame
Immediately after the intervention
Secondary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score
Description
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.
Time Frame
one week
Title
Tampa Scale for Kinesiophobia
Description
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 ).
Time Frame
one week
Title
Global Rating Of Change Scale
Description
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.
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pongchai Watcharakhueankhan, Master
Phone
+44 7849226313
Email
pwatcharakhueankhan@uclan.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Richards, Professor
Organizational Affiliation
University of Central Lancashire
Official's Role
Study Director
Facility Information:
Facility Name
Physical Therapy Center (Pinklao) Faculty of Physical Therapy, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Physical Therapy Center (Pinklao) Faculty of Physical Therapy,
Phone
(+66)2-441-5450
Ext
20605
Email
komsak.sin@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Pongchai Watcharakhueankhan, Master
Facility Name
Faculty of Physical Therapy, Mahidol University
City
Nakhon Pathom
ZIP/Postal Code
73170
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faculty of Physical Therapy, Mahidol University
Phone
(+66)2-441-5450
Ext
20605
Email
komsak.sin@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Pongchai Watcharakhueankhan, Master

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
To be confirmed

Learn more about this trial

The Effects of Kinesio Taping on Biomechanical and Clinical Outcomes in Runners With Iliotibial Band Friction Syndrome

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