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Effects of KT and Rigid Taping in Knee OA.

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Kinesio Tape Group
Rigid Tape Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, kinesio tape and rigid tape

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Atta Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Kinesio Tape Group

Rigid tape Group

Arm Description

Kinesio tape applied along with conventional treatment

Rigid tape applied along with conventional treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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

Full Information

First Posted
July 7, 2023
Last Updated
July 13, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05946434
Brief Title
Effects of KT and Rigid Taping in Knee OA.
Official Title
Comparisons of the Effects of Kinesio Taping and Rigid Taping in Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
June 12, 2023 (Actual)
Study Completion Date
June 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Osteoarthritis, kinesio tape and rigid tape

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio Tape Group
Arm Type
Experimental
Arm Description
Kinesio tape applied along with conventional treatment
Arm Title
Rigid tape Group
Arm Type
Experimental
Arm Description
Rigid tape applied along with conventional treatment
Intervention Type
Other
Intervention Name(s)
Kinesio Tape Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Rigid Tape Group
Intervention Description
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
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities (WOMAC) Osteoarthritis (OA) Index
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
ROM
Description
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.
Time Frame
6 months.
Title
Visual Analogue Scale
Description
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
Time Frame
6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lal Gul Khan, MScNMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atta Memorial Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46222
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of KT and Rigid Taping in Knee OA.

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