Clinical trial NCT05351996: Kinesiotaping in Knee Osteoarthritis
Official title: Does Kinesiotaping Effective for Knee Osteoarthritis? Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Knee osteoarthritis
Kinesiotape
Pain
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 57
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Pain intensity-rest at 1st hour, 3rd week, and 7th week
timeFrame: Baseline (week 0), 1st hour, 3rd week, 7th week
measure: Change from Baseline Pain intensity-activity at 1st hour, 3rd week, and 7th week
timeFrame: Baseline (week 0), 1st hour, 3rd week , 7th week
Secondary outcomes:
measure: Change from Baseline Knee-Related Health Status at 1st hour, 3rd week, and 7th week
timeFrame: Baseline (week 0), 1st hour, 3rd week , 7th week
measure: Change from Baseline Pain-free Knee Range of Motion at 1st hour, 3rd week, and 7th week
timeFrame: Baseline (week 0), 1st hour, 3rd week , 7th week
measure: Change from Baseline Physical Function at 1st hour, 3rd week, and 7th week
timeFrame: Baseline (week 0), 1st hour, 3rd week , 7th week
measure: Change from Baseline Static Postural Stability at 1st hour, 3rd week, and 7th week
timeFrame: Baseline (week 0), 1st hour, 3rd week , 7th week
measure: Change from Baseline Dynamic Postural Stability at 1st hour, 3rd week, and 7th week
timeFrame: Baseline (week 0), 1st hour, 3rd week , 7th week
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: University of Health Sciences Izmir Bozyaka Training and Research Hospital
Study officials:
affiliation: University of Health Sciences Izmir Bozyaka Training and Research Hospital
name: Nesibe Doğan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Health Sciences Izmir Bozyaka Training and Research Hospital
name: Hayriye Yılmaz, MSc, PT
role: STUDY_CHAIR
affiliation: University of Health Sciences Izmir Bozyaka Training and Research Hospital
name: Buğra İnce, MD
role: STUDY_CHAIR
affiliation: University of Health Sciences Izmir Bozyaka Training and Research Hospital
name: Şeniz Akçay, Assoc. Prof.
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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. doi: 10.1097/PHM.0000000000000520.
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.
citation: 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.