NCT04164316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

November 8, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 14, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2022

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

2.4 years

First QC Date

November 8, 2019

Last Update Submit

January 22, 2025

Conditions

Keywords

Kinesio TapingBiomechanicsIliotibial Band Friction SyndromeClinical Outcomes

Outcome Measures

Primary Outcomes (4)

  • 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

  • Pelvis, Hip, Knee, and Ankle angle.

    Three-dimensional joint kinematics measurement by motion analysis capture

    Immediately after the intervention

  • Hip, Knee, and Ankle Moments

    Three-dimensional joint kinematics measurement by motion analysis capture

    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.

    Immediately after the intervention

Secondary Outcomes (3)

  • Knee Injury and Osteoarthritis Outcome Score

    one week

  • Tampa Scale for Kinesiophobia

    one week

  • Global Rating Of Change Scale

    one week

Study Arms (2)

Kinesio Tape No Tension

SHAM COMPARATOR

Kinesio Tape No Tension

Device: Kinesio Tape

Kinesio Tape with Tension

ACTIVE COMPARATOR

Kinesio Tape with Tension

Device: Kinesio Tape

Interventions

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

Kinesio Tape No TensionKinesio Tape with Tension

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Physical Therapy Center (Pinklao) Faculty of Physical Therapy, Mahidol University

Bangkok, 10700, Thailand

Location

Faculty of Physical Therapy, Mahidol University

Nakhon Pathom, 73170, Thailand

Location

MeSH Terms

Conditions

Iliotibial Band Syndrome

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesCumulative Trauma DisordersSprains and Strains

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Jim Richards, Professor

    University of Central Lancashire

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is using Kinesio Tape which is difficult to blind the patients and clinicians.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Exploratory Randomized Control Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 15, 2019

Study Start

January 14, 2020

Primary Completion

May 23, 2022

Study Completion

January 1, 2024

Last Updated

January 24, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

To be confirmed

Locations