Kinesiotaping in Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

Does Kinesiotaping Effective for Knee Osteoarthritis? Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05351996
• Other study ID #: 11/09/2019-06
• Status: Completed
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: October 26, 2021

Study information

• Verified date: April 2022
• Source: Bozyaka Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Non-pharmacological treatments are recommended as first-line management in knee osteoarthritis. Kinesiotape was regarded as a supplementary intervention for patients with knee osteoarthritis. Although the results are conflicting, regarding knee osteoarthritis, recently published studies indicate beneficial effects of kinesiotape on knee-related health status, pain, quadriceps muscle strength, and range of motion. On the other hand, the measurements were performed immediately following taping or within a short-term period. The inconsistency of the study data still indicates that the efficacy of kinesiotape in knee osteoarthritis should be evaluated in randomized controlled trials. Therefore a study that investigates both short and long-term follow-up results are warranted.

This study aimed to determine the immediate and long-term effects of the single and repetitive application of kinesiotape on pain, knee joint range of motion, postural stability, and physical performance in participants with knee osteoarthritis. The results of this study will support evidence-based reports based on the effectiveness of kinesiotape in knee osteoarthritis and recommendations for future studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 26, 2021
• Est. primary completion date: October 26, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Kinesiotape
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.
• Sham-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.

Other:
• Home-based exercise program
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.

Locations

Country	Name	City	State
Turkey	University of Health Sciences Izmir Bozyaka Training and Research Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

Donec V, Kubilius R. The effectiveness of Kinesio Taping(®) 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. — View Citation

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. — View Citation

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. Review. Erratum in: Arthritis Care Res (Hoboken). 2021 May;73(5):764. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change from Baseline Knee-Related Health Status at 1st hour, 3rd week, and 7th week	To determine the baseline and the degree of change in knee-related health status Western Ontario and McMaster Universities Osteoarthritis Index was applied. Western Ontario and McMaster Universities Osteoarthritis Index, is a widely valid and reliable outcome measurement scale in patients with knee osteoarthritis. The scale consists of 24 items and is divided into three dimensions; pain; stiffness, and functionality.	Baseline (week 0), 1st hour, 3rd week , 7th week
Secondary	Change from Baseline Pain-free Knee Range of Motion at 1st hour, 3rd week, and 7th week	Active pain-free knee range of motion examination was performed by a 360° double-armed universal goniometer. Knee active flexion range of motion angle without pain was measured in the supine position while the axis of the goniometer was on the femur's lateral epicondyle. For active knee extension range of motion, the investigator recorded the angle that which the participant extends the knee as much as possible. If there was an inability to reach the 0-degree starting position, the angle was given a negative value reflecting the angle missing from the full extension. Three assessment was performed and the mean value was recorded as active flexion and extension angle.	Baseline (week 0), 1st hour, 3rd week , 7th week
Secondary	Change from Baseline Physical Function at 1st hour, 3rd week, and 7th week	The physical function of the participants enrolled in the study was evaluated by the 50-meter walking test will the subjects walk 2.5 return journeys between two cones placed 10 m apart along a walking course. The participants stood beside the cone. They were instructed to walk to the other when signaled by the investigator, go around it to the outer side, and walk back again as fast as possible.; The time taken the task completed assessed by the same chronometer was recorded	Baseline (week 0), 1st hour, 3rd week , 7th week
Secondary	Change from Baseline Static Postural Stability at 1st hour, 3rd week, and 7th week	The quantitative measure of the balance and postural stability of participants was performed by the Biodex Balance System (BBS). Participants completed three trial repetitions before static balance tests. For the static balance test, the participants were asked to stand with two legs on the center of the locked platform of the BBS. Three evaluations were performed in each measurement session and a mean score was calculated from the three trials. The device provides three postural stability indices (PSI) obtained by calculating the standard deviations of the degrees of an inclination concerning the zero point: overall static postural stability index (sPSI_O), static anteroposterior postural stability index (sPSI_AP), and static mediolateral postural stability index (sPSI_ML).	Baseline (week 0), 1st hour, 3rd week , 7th week
Secondary	Change from Baseline Dynamic Postural Stability at 1st hour, 3rd week, and 7th week	The quantitative measure of the balance and postural stability of participants was performed by the Biodex Balance System (BBS). Participants completed three trial repetitions before dynamic balance tests.; During the dynamic balance test, the platform moves simultaneously to the anteroposterior (AP), or mediolateral (ML) directions in 12 different stability levels (level 1 is the least stable; level 12 is the most stable level within a 20-degree range of inclination). Dynamic PSI (dPSI) represents the variance of foot platform displacement in degrees, from level, in all motions during the test. A high number is indicative of a lot of movement during the test. Dynamic balance test was performed on the most stable level with the following parameters: duration: 20 seconds, stability level: 12, and stance: two legs	Baseline (week 0), 1st hour, 3rd week , 7th week