NCT05351996

Brief Summary

Kinesiotape is one of the treatment choices for the patients with knee osteoarthritis. Unlike the brace, it seems to be an important advantage in kinesiotape application in that it permits the movement of the joint. However, kinesiotape is conditionally recommended for knee osteoarthritis in the 2019 American College of Rheumatology treatment recommendations due to limiting the quality of evidence, using various application methods, and the lack of blindness concerning its use is not possible. The aim of the study is to determine the effects of kinesiotaping on pain, physical performance, knee range of motion, and postural stability in knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

1.9 years

First QC Date

April 18, 2022

Last Update Submit

April 23, 2022

Conditions

Keywords

Knee osteoarthritisKinesiotapePain

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline Pain intensity-rest at 1st hour, 3rd week, and 7th week

    Pain intensity was assessed by using the Visual Analogue Scale (VAS). Each patient was asked to indicate pain intensity during rest at each assessment point (on a 0-10 points numerical pain rating scale; higher scores indicate severe pain).

    Baseline (week 0), 1st hour, 3rd week, 7th week

  • Change from Baseline Pain intensity-activity at 1st hour, 3rd week, and 7th week

    Pain intensity was assessed by using the Visual Analogue Scale (VAS). Each patient was asked to indicate pain intensity during 50-meter walking test at each assessment point (on a 0-10 points numerical pain rating scale; higher scores indicate severe pain).

    Baseline (week 0), 1st hour, 3rd week , 7th week

Secondary Outcomes (5)

  • Change from Baseline Knee-Related Health Status at 1st hour, 3rd week, and 7th week

    Baseline (week 0), 1st hour, 3rd week , 7th week

  • Change from Baseline Pain-free Knee Range of Motion at 1st hour, 3rd week, and 7th week

    Baseline (week 0), 1st hour, 3rd week , 7th week

  • Change from Baseline Physical Function at 1st hour, 3rd week, and 7th week

    Baseline (week 0), 1st hour, 3rd week , 7th week

  • Change from Baseline Static Postural Stability at 1st hour, 3rd week, and 7th week

    Baseline (week 0), 1st hour, 3rd week , 7th week

  • Change from Baseline Dynamic Postural Stability at 1st hour, 3rd week, and 7th week

    Baseline (week 0), 1st hour, 3rd week , 7th week

Study Arms (2)

Kinesiotape

ACTIVE COMPARATOR

The participants received kinesiotape to the rectus femoris muscle.

Device: KinesiotapeOther: Home-based exercise program

Sham-kinesiotape

SHAM COMPARATOR

Non-specific taping was applied.

Device: Sham-kinesiotapeOther: Home-based exercise program

Interventions

The participants received kinesiotape application three times with one-week intervals. Y strip tape was used. The interventionist applied the band to the rectus femoris muscle with facilitation technique.

Kinesiotape

The participants received sham-kinesiotape application three times with one-week intervals. In the sham group, the interventionist adhered KT to the rectus femoris transversely, without stretching.

Sham-kinesiotape

Participants were taught exercise program training. The exercise intervention was based on quadriceps and knee flexor muscle group strengthening, and knee joint range of motion exercises, in their home.

KinesiotapeSham-kinesiotape

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAs the pain intensity and pain threshold may be effected by the gender differences, the enrolled participants were consisted of females.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pain for a minimum of 3 months
  • Pain intensity within the last week minimum of 3 according to the visual analogue scale (VAS) at the symptomatic knee
  • Grade 2-3 knee OA according to the Kellgren and Lawrence Scale
  • Ability to perform the tests

You may not qualify if:

  • Fragile, very sensitive skin, or lesions in the area
  • Inflammatory arthritis
  • Inability to perform functional tests
  • Pregnancy
  • Use of drugs associated with a psychiatric disorder
  • Previous joint replacement surgery for knee/hip joints
  • Diagnosis with balance disorder
  • Disorders that may cause loss of muscle strength in the lower extremities
  • Previous experience with the Kinesiotaping method

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Izmir Bozyaka Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (5)

  • Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res (Hoboken). 2020 Feb;72(2):149-162. doi: 10.1002/acr.24131. Epub 2020 Jan 6.

    PMID: 31908149BACKGROUND
  • Donec V, Kubilius R. The effectiveness of Kinesio Taping(R) for mobility and functioning improvement in knee osteoarthritis: a randomized, double-blind, controlled trial. Clin Rehabil. 2020 Jul;34(7):877-889. doi: 10.1177/0269215520916859. Epub 2020 May 6.

    PMID: 32372651BACKGROUND
  • Kaya Mutlu E, Mustafaoglu R, Birinci T, Razak Ozdincler A. Does Kinesio Taping of the Knee Improve Pain and Functionality in Patients with Knee Osteoarthritis?: A Randomized Controlled Clinical Trial. Am J Phys Med Rehabil. 2017 Jan;96(1):25-33. doi: 10.1097/PHM.0000000000000520.

    PMID: 27149590BACKGROUND
  • Wageck B, Nunes GS, Bohlen NB, Santos GM, de Noronha M. Kinesio Taping does not improve the symptoms or function of older people with knee osteoarthritis: a randomised trial. J Physiother. 2016 Jul;62(3):153-8. doi: 10.1016/j.jphys.2016.05.012. Epub 2016 Jun 16.

    PMID: 27320828BACKGROUND
  • Cho HY, Kim EH, Kim J, Yoon YW. Kinesio taping improves pain, range of motion, and proprioception in older patients with knee osteoarthritis: a randomized controlled trial. Am J Phys Med Rehabil. 2015 Mar;94(3):192-200. doi: 10.1097/PHM.0000000000000148.

    PMID: 25706053BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneePain

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Nesibe Doğan, MD

    University of Health Sciences Izmir Bozyaka Training and Research Hospital

    PRINCIPAL INVESTIGATOR
  • Hayriye Yılmaz, MSc, PT

    University of Health Sciences Izmir Bozyaka Training and Research Hospital

    STUDY CHAIR
  • Buğra İnce, MD

    University of Health Sciences Izmir Bozyaka Training and Research Hospital

    STUDY CHAIR
  • Şeniz Akçay, Assoc. Prof.

    University of Health Sciences Izmir Bozyaka Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University of Health Sciences Bozyaka Training and Research Hospital Physical Medicine and Rehabilitation Department, Assoc. Prof.

Study Record Dates

First Submitted

April 18, 2022

First Posted

April 28, 2022

Study Start

November 20, 2019

Primary Completion

October 26, 2021

Study Completion

October 26, 2021

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations