- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05946434
Effects of KT and Rigid Taping in Knee OA.
Comparisons of the Effects of Kinesio Taping and Rigid Taping in Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Osteoarthritis (OA), also referred to as degenerative joint disease, primary OA, wear-and-tear arthritis, or age-related arthritis, is the most common cause of disability in the US and around the world. In medical terminology, arthritis refers to joint inflammation. More than 100 rheumatic diseases and ailments that affect the joints, the tissues surrounding the joints, and other connective tissue are collectively referred to as arthritis in the public health sector(1). By 2020, OA will rank as the fourth most common cause of disability, according to the World Health Organization (WHO), making it one of the most incapacitating musculoskeletal ailments. Globally, the socioeconomic, psychological, and physical toll increased. The main leading factor affecting mobility is knee osteoarthritis. Among patients with knee OA, knee discomfort, decreased knee flexibility, and functional impossibility are frequent clinical symptoms during daily activities(2). Almost any joint can be compromised by osteoarthritis, although the hands, knees, hips, and feet are the most frequently affected ,but most commonly involved joint is knee joint(3). Knee osteoarthritis (OA) is a prevalent, degenerative, multifactorial joint condition that is characterized by chronic pain and functional dysfunction . Nearly half of all OA cases worldwide are knee OA, which gets worse as people get older and more obese(4, 5). Knee discomfort, which contributes to OA, was also brought on by inactivity or a sedentary lifestyle. In order to prevent pain when engaging in physical activity, people with knee OA further restrict their mobility(6).
Diagnosis of Knee Osteoarthritis: The presence of typical symptoms, physical exam findings, test data, and imaging characteristics all help to confirm a medical diagnosis of knee OA. Knee osteoarthritis can't be diagnosed based on single finding from the followings Literature review: The randomized control trial was conducted in Turkey on osteoarthritis patient to see the effect of kinesio taping results indicate that there were clear decrease in Nottingham Health Profile (NHP) scores (15). In this study there were 13 males (32%) and 28 females (68%). In both groups (K Tape and sham tape) VAS for activity pain, VAS for nocturnal pain, Lequesne index score, NHP score decreased significantly. NHP energy scores were different significantly between the groups in favor of sham taping at the end of the 12-day period. Another research conducted in Germany, the main finding of this study is that wearing a kinesio tape over 3 consecutive days is effective to improve the self-reported perception of pain, joint stiffness, and physical function in patients with OA compared with a sham tape or no intervention (16). The research conducted in Iran on effect of kinesio taping on functional disability in knee osteoarthritic patients result shows that in the kinesio tape group, a statistically significant improvement was observed in the reconstruction of the joint sense position at 30 and 60 angles of knee flexion before and after treatment (17). Therapeutic taping seemed to be superior to control taping in pain control for knee osteoarthritis. Non-elastic taping, but not elastic taping, provides benefits in pain reduction and functional performance (18)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan, 46222
- Atta Memorial Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age group 40 to 60 years of age.
- Both genders.
- Radiological findings showing symptomatic 1-3 grade knee osteoarthritis.
- Sub-acute and chronic knee pain.
Exclusion Criteria:
- Systemic rheumatoid disease.
- Hypersensitive skin or lesions in the areas of application for tapes.
- Inability to perform functional tests needed according to the research protocol
- Diagnosed or suspected cancer in the region.
- Within 6 months of intra-articular injections.
- Constant use of painkillers for alleviation of pain in different regions of the body.
- Constant use of any orthotics.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kinesio Tape Group
Kinesio tape applied along with conventional treatment
|
Physiotherapy Protocol Followed:
Same procedure will be followed in all follow ups at day 1, day 14 and day 28. Physiotherapy Protocol Followed:
Same procedure will be followed in all follow ups at day 1, day 14 and day 28 |
|
Experimental: Rigid tape Group
Rigid tape applied along with conventional treatment
|
Physiotherapy Protocol Followed:
Same procedure will be followed in all follow ups at day 1, day 14 and day 28. Physiotherapy Protocol Followed:
Same procedure will be followed in all follow ups at day 1, day 14 and day 28 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Western Ontario and McMaster Universities (WOMAC) Osteoarthritis (OA) Index
Time Frame: 6 months
|
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis (OA) Index is a tested questionnaire to assess symptoms and physical functional disability in patients with OA of the knee and the hip
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ROM
Time Frame: 6 months.
|
The Goniometer is an accurate and trustworthy way of measuring knee ROM, as well as a handy and readily available measure of outcome for scientific studies and physiotherapy practice.
|
6 months.
|
|
Visual Analogue Scale
Time Frame: 6 months.
|
The Visual Analogue Scale (VAS) is a pain outcome measure that is dependable, legitimate, receptive and widely utilized. It's made up of a single 10 cm horizontal line with two designations, "no pain" and "worst possible pain," positioned at each end of the line. Participants are instructed to put a pointy marker on the line representing their level of pain. Visual Analogue Scale has high reliability for pain which is 0.97 and has minimal measurement error which is 0.03 |
6 months.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lal Gul Khan, MScNMPT, Riphah International University
Publications and helpful links
General Publications
- Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001. Erratum In: Clin Geriatr Med. 2013 May;29(2):ix.
- Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.
- Alghadir AH, Anwer S, Iqbal A, Iqbal ZA. Test-retest reliability, validity, and minimum detectable change of visual analog, numerical rating, and verbal rating scales for measurement of osteoarthritic knee pain. J Pain Res. 2018 Apr 26;11:851-856. doi: 10.2147/JPR.S158847. eCollection 2018.
- 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.
- Ouyang JH, Chang KH, Hsu WY, Cho YT, Liou TH, Lin YN. Non-elastic taping, but not elastic taping, provides benefits for patients with knee osteoarthritis: systemic review and meta-analysis. Clin Rehabil. 2018 Jan;32(1):3-17. doi: 10.1177/0269215517717307. Epub 2017 Jun 29.
- Rahlf AL, Braumann KM, Zech A. Kinesio Taping Improves Perceptions of Pain and Function of Patients With Knee Osteoarthritis: A Randomized, Controlled Trial. J Sport Rehabil. 2019 Jul 1;28(5):481-487. doi: 10.1123/jsr.2017-0306. Epub 2018 Dec 12.
- Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24.
- Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183.
- Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
- Peter WF, Jansen MJ, Hurkmans EJ, Bloo H, Dekker J, Dilling RG, Hilberdink W, Kersten-Smit C, de Rooij M, Veenhof C, Vermeulen HM, de Vos RJ, Schoones JW, Vliet Vlieland TP; Guideline Steering Committee - Hip and Knee Osteoarthritis. Physiotherapy in hip and knee osteoarthritis: development of a practice guideline concerning initial assessment, treatment and evaluation. Acta Reumatol Port. 2011 Jul-Sep;36(3):268-81.
- Epskamp S, Dibley H, Ray E, Bond N, White J, Wilkinson A, et al. Range of motion as an outcome measure for knee osteoarthritis interventions in clinical trials: an integrated review. Physical Therapy Reviews. 2020;25(5-6):462-81.
- Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.
- Yoshida A, Kahanov L. The effect of kinesio taping on lower trunk range of motions. Res Sports Med. 2007 Apr-Jun;15(2):103-12. doi: 10.1080/15438620701405206.
- Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, Lapadula G, Punzi L; GOnorthrosis and Quality Of Life Assessment (GOQOLA). Reliability and validity of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003 Aug;11(8):551-60. doi: 10.1016/s1063-4584(03)00089-x.
- Hinman RS, Bennell KL, Crossley KM, McConnell J. Immediate effects of adhesive tape on pain and disability in individuals with knee osteoarthritis. Rheumatology (Oxford). 2003 Jul;42(7):865-9. doi: 10.1093/rheumatology/keg233. Epub 2003 Mar 31.
- Felson DT, Lawrence RC, Dieppe PA, Hirsch R, Helmick CG, Jordan JM, Kington RS, Lane NE, Nevitt MC, Zhang Y, Sowers M, McAlindon T, Spector TD, Poole AR, Yanovski SZ, Ateshian G, Sharma L, Buckwalter JA, Brandt KD, Fries JF. Osteoarthritis: new insights. Part 1: the disease and its risk factors. Ann Intern Med. 2000 Oct 17;133(8):635-46. doi: 10.7326/0003-4819-133-8-200010170-00016.
- McAlindon TE, LaValley MP, Harvey WF, Price LL, Driban JB, Zhang M, Ward RJ. Effect of Intra-articular Triamcinolone vs Saline on Knee Cartilage Volume and Pain in Patients With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA. 2017 May 16;317(19):1967-1975. doi: 10.1001/jama.2017.5283.
- Shan L, Shan B, Suzuki A, Nouh F, Saxena A. Intermediate and long-term quality of life after total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Am. 2015 Jan 21;97(2):156-68. doi: 10.2106/JBJS.M.00372.
- Ho-Pham LT, Lai TQ, Mai LD, Doan MC, Pham HN, Nguyen TV. Prevalence of radiographic osteoarthritis of the knee and its relationship to self-reported pain. PLoS One. 2014 Apr 10;9(4):e94563. doi: 10.1371/journal.pone.0094563. eCollection 2014.
- Sharma L. Osteoarthritis of the Knee. N Engl J Med. 2021 Jan 7;384(1):51-59. doi: 10.1056/NEJMcp1903768. No abstract available.
- Messier SP, Mihalko SL, Legault C, Miller GD, Nicklas BJ, DeVita P, Beavers DP, Hunter DJ, Lyles MF, Eckstein F, Williamson JD, Carr JJ, Guermazi A, Loeser RF. Effects of intensive diet and exercise on knee joint loads, inflammation, and clinical outcomes among overweight and obese adults with knee osteoarthritis: the IDEA randomized clinical trial. JAMA. 2013 Sep 25;310(12):1263-73. doi: 10.1001/jama.2013.277669.
- Melese H, Alamer A, Hailu Temesgen M, Nigussie F. Effectiveness of Kinesio Taping on the Management of Knee Osteoarthritis: A Systematic Review of Randomized Controlled Trials. J Pain Res. 2020 May 28;13:1267-1276. doi: 10.2147/JPR.S249567. eCollection 2020.
- Malik FB, Memon AG, Shah S, Latif D, Afzal MF, Memon SAJTRJ. PREVALENCE OF KNEE OSTEOARTHRITIS AND QUALITY OF LIFE AMONG MIDDLE AGED ADULTS OF PAKISTAN: soi: 21-2017/re-trjvol06iss01p280. 2022;6(01):280-3.
- Sanchez C, Pesesse L, Gabay O, Delcour JP, Msika P, Baudouin C, Henrotin YE. Regulation of subchondral bone osteoblast metabolism by cyclic compression. Arthritis Rheum. 2012 Apr;64(4):1193-203. doi: 10.1002/art.33445. Epub 2011 Oct 27.
- Gibson T, Hameed K, Kadir M, Sultana S, Fatima Z, Syed A. Knee pain amongst the poor and affluent in Pakistan. Br J Rheumatol. 1996 Feb;35(2):146-9. doi: 10.1093/rheumatology/35.2.146.
- Abulhasan JF, Grey MJJJoFM, kinesiology. Anatomy and physiology of knee stability. 2017;2(4):34.
- Masouros S, Bull A, Amis AJO, Trauma. (i) Biomechanics of the knee joint. 2010;24(2):84-91.
- Eaton CB. Obesity as a risk factor for osteoarthritis: mechanical versus metabolic. Med Health R I. 2004 Jul;87(7):201-4.
- Luijkx T, Pai VJDnahroak-a-l-f-c-o-o-o-kDp. Kellgren and Lawrence system for classification of osteoarthritis of knee. 2016;7(6).
- Zeng C, Dubreuil M, LaRochelle MR, Lu N, Wei J, Choi HK, Lei G, Zhang Y. Association of Tramadol With All-Cause Mortality Among Patients With Osteoarthritis. JAMA. 2019 Mar 12;321(10):969-982. doi: 10.1001/jama.2019.1347.
- Deyle GD, Allen CS, Allison SC, Gill NW, Hando BR, Petersen EJ, Dusenberry DI, Rhon DI. Physical Therapy versus Glucocorticoid Injection for Osteoarthritis of the Knee. N Engl J Med. 2020 Apr 9;382(15):1420-1429. doi: 10.1056/NEJMoa1905877.
- Thorlund JB, Juhl CB, Roos EM, Lohmander LS. Arthroscopic surgery for degenerative knee: systematic review and meta-analysis of benefits and harms. BMJ. 2015 Jun 16;350:h2747. doi: 10.1136/bmj.h2747.
- Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2015 Jan 9;1(1):CD004376. doi: 10.1002/14651858.CD004376.pub3.
- Wang C, Schmid CH, Iversen MD, Harvey WF, Fielding RA, Driban JB, Price LL, Wong JB, Reid KF, Rones R, McAlindon T. Comparative Effectiveness of Tai Chi Versus Physical Therapy for Knee Osteoarthritis: A Randomized Trial. Ann Intern Med. 2016 Jul 19;165(2):77-86. doi: 10.7326/M15-2143. Epub 2016 May 17.
- Kocyigit F, Turkmen MB, Acar M, Guldane N, Kose T, Kuyucu E, Erdil M. Kinesio taping or sham taping in knee osteoarthritis? A randomized, double-blind, sham-controlled trial. Complement Ther Clin Pract. 2015 Nov;21(4):262-7. doi: 10.1016/j.ctcp.2015.10.001. Epub 2015 Oct 9.
- Wieczorek M, Rotonda C, Coste J, Pouchot J, Saraux A, Guillemin F, Rat AC. Trajectory analysis combining pain and physical function in individuals with knee and hip osteoarthritis: results from the French KHOALA cohort. Rheumatology (Oxford). 2020 Nov 1;59(11):3488-3498. doi: 10.1093/rheumatology/keaa148.
- Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020 Nov 26;29-30:100587. doi: 10.1016/j.eclinm.2020.100587. eCollection 2020 Dec.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RiphahIU Muhammad Saad
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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