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Knee OsteoarthritisNCT05946434

Effects of KT and Rigid Taping in Knee OA.

A study testing Kinesio Tape Group and Rigid Tape Group in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to compare the effects of kinesio taping and rigid taping in Knee Osteoarthritis to alleviate symptoms like pain, reduce range of motion and functional limitations. Read more about this study

Who is it for?
Ages 40 to 60 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Kinesio Tape Group and Rigid Tape Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 sitePakistan
Study dates
15 Jan 2023to 20 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Atta Memorial Hospital

    Rawalpindi, Punjab Province, 46222

Other trials in Pakistan

About this study

Official title: Comparisons of the Effects of Kinesio Taping and Rigid Taping in Knee Osteoarthritis

The purpose of the study is to compare the effects of kinesio taping and rigid taping in Knee Osteoarthritis to alleviate symptoms like pain, reduce range of motion and functional limitations. A randomized control trial was conducted at Atta Memorial Hospital, Airport Society, Rawalpindi and Makkah Medical Complex, Rawalpindi. The sample size was 36 calculated through G-Power. The participants were divided into two interventional groups each having 18 participants. The study duration was six months. Sampling technique applied was Non probability convenient sampling. Only 40 to 60 years' participants with grade 1-3 Knee Osteoarthritis according to kellgren-Lawrence scale were included in the study. Tools used in this study are Visual analogue scale, WOMAC Index, timed up and go test and Goniometer self-structured Questionnaire. Data was collected before and immediately after the application of intervention on First day and then again at the end of session on 14th and 28th day. Data analyzed through SPSS version 23.

Read the 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)

Being tested
Kinesio Tape Group, Rigid Tape Group
Keywords
Knee Osteoarthritis, kinesio tape and rigid tape
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kinesio Tape GroupOther

    Physiotherapy Protocol Followed:

    • Hot pack and TENS application for 10 minutes.
    • Knee isometric exercises by placing roller beneath knee joint and pressing it by keeping leg straight and holding it for 10-15 seconds with 10 repetitions.
    • Stretching of hamstrings and gastrocnemius muscles, maintaining stretch for 20 seconds and 7 repetitions should be performed.
    • Tibio-femoral glides and patellar mobilizations will be performed.
    • At the end kinesio taping will be performed at knee joint for inhibition.

    Same procedure will be followed in all follow ups at day 1, day 14 and day 28.

  • Rigid Tape GroupOther

    Physiotherapy Protocol Followed:

    • Hot pack and TENS application for 10 minutes.
    • Knee isometric exercises by placing roller beneath knee joint and pressing it by keeping leg straight and holding it for 10-15 seconds with 10 repetitions.
    • Stretching of hamstrings and gastrocnemius muscles, maintaining stretch for 20 seconds and 7 repetitions should be performed.
    • Tibio-femoral glides and patellar mobilizations will be performed.
    • At the end rigid tape will be applied on knee joint to provide stability.

    Same procedure will be followed in all follow ups at day 1, day 14 and day 28

Study groups in NCT05946434
Study groupRoleWhat they receive
Kinesio Tape GroupExperimentalKinesio tape applied along with conventional treatment
Receives: Other: Kinesio Tape Group; Other: Rigid Tape Group
Rigid tape GroupExperimentalRigid tape applied along with conventional treatment
Receives: Other: Kinesio Tape Group; Other: Rigid Tape Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Western Ontario and McMaster Universities (WOMAC) Osteoarthritis (OA) Index

    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

    Measured: 6 months

Secondary outcomes (2)
  1. ROM

    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.

    Measured: 6 months.

  2. Visual Analogue Scale

    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

    Measured: 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2023
  2. Study start15 Jan 2023
  3. Primary completion12 Jun 2023
  4. Study completion20 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05946434
Sponsor's protocol ID
RiphahIU Muhammad Saad
Status last verified
Jul 2023
First submitted
7 Jul 2023
Last updated
14 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29035179
  • 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.

    PubMed 32547187
  • 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.

    PubMed 33560326
  • 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.

    PubMed 22034083
  • 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.

    PubMed 8612027
  • 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.

    PubMed 24722559
  • Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.

    PubMed 24024017
  • 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.

    PubMed 25706053
  • 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.

    PubMed 15354794
  • 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.

    PubMed 11033593
  • 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).

  • Sharma L. Osteoarthritis of the Knee. N Engl J Med. 2021 Jan 7;384(1):51-59. doi: 10.1056/NEJMcp1903768. No abstract available.

    PubMed 33406330

Questions about this trial

What is this clinical trial studying?

A study testing Kinesio Tape Group and Rigid Tape Group in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Western Ontario and McMaster Universities (WOMAC) Osteoarthritis (OA) Index (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05946434, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.

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