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Comparing the Effectiveness of Kinesio Taping and Knee Orthosis in Patients With Patellofemoral Pain Syndrome

Primary Purpose

Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome, Patellofemoral Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio taping
Orthosis
Control
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Patellofemoral Pain Syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Be between the ages of 18-45 Patients with a body mass index (BMI) less than 29.9 Anterior knee pain defined as 3 points on the 10 cm Visual Analogue Scale when performing at least two activities of sitting for a long time, climbing/descending stairs, squatting, running and jumping Exclusion Criteria: Patients with knee osteoarthritis History of surgery involving the lower extremity Patellar or quadriceps tendinopathy Injury to the meniscus or knee ligaments Patients showing an allergic response to kinesio tape Patients previously treated with PFAS Existing hip pathologies History of patellar subluxation or dislocation Patients with neurological disorders Patients who did not fill out the voluntary consent form

Sites / Locations

  • Istanbul Medipol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Kinesio taping group

Orthosis group

Control group

Arm Description

In addition to the standard exercise program, kinesio taping was applied to the knee for 6 weeks.

In addition to the standard exercise program, they were asked to use a knee orthosis for 6 weeks.

A standard exercise program was applied for 6 weeks.

Outcomes

Primary Outcome Measures

Change in baseline Kujala scores of patients treated at week 6
It is a score that evaluates symptoms and function in patients with patellofemoral pain syndrome. Patients were asked to complete this score before starting the treatment and again at the end of the 6-week treatment.

Secondary Outcome Measures

Change in baseline Visual Analogue Scale of patients treated at week 6
It is a scale that evaluates pain. Patients were asked to complete this scale before starting the treatment and again at the end of the 6-week treatment.
Change in baseline Knee Injury and Osteoarthritis Outcome Score of patients treated at week 6
Knee Injury and Osteoarthritis Outcome Score (KOOS) is a score used to evaluate symptoms and functional status related to knee injury and knee osteoarthritis. Patients were asked to complete this score before starting the treatment and again at the end of the 6-week treatment.
Change in baseline isokinetic strength test of patients treated at week 6
This test is a strength test performed with an isokinetic strength testing machine. This test was applied to the patients before starting the treatment and at the end of the 6-week treatment.

Full Information

First Posted
July 3, 2023
Last Updated
August 9, 2023
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05995210
Brief Title
Comparing the Effectiveness of Kinesio Taping and Knee Orthosis in Patients With Patellofemoral Pain Syndrome
Official Title
Comparing the Effectiveness of Kinesio Taping and Knee Orthosis in Patients With Patellofemoral Pain Syndrome: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
May 5, 2023 (Actual)
Study Completion Date
June 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

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 aim of the study is to compare the efficacy of kinesio taping treatment and knee orthosis treatment in Patellofemoral Pain Syndrome (PFAS). 54 patients were included in the study and the patients were divided into 3 groups as kinesio taping group (KTG) (n=18), orthotics group (OG) (n=18) and control group (CG) (n=18). A progressive exercise program was applied to all groups and patients were treated 2 days a week for 6 weeks.While kinesio taping was applied to KTG in each session, knee orthosis was given to OG and they were asked to use it for 6 weeks. Visual Analogue Scale (VAS), Kujala Score, Knee injury and Osteoarthritis Outcome Score (KOOS), isokinetic strength test (IST) and joint position sense (JPS) test were used in the evaluation.
Detailed Description
Patients were divided into 3 groups as patellofemoral knee orthosis group, kinesio taping group and control group. Randomization of group allocation was done using the website "https://www.randomizer.org". Patients were unaware of the other group's treatment program and group allocation. All participants signed an informed consent form before the study. The primary outcome measure of our study was the Kujala Score, and the secondary outcome measures were the Knee Injury and Osteoarthritis Outcome Score (KOOS), Visual Analog Scale (VAS), quadriceps and hamstring isokinetic muscle strength, and knee joint position sense. The evaluations were performed before and after treatment. All patients were informed about the disease and treatment process before treatment. Patients were informed about the things they should pay attention to for pain management in daily life activities and suggestions were made. In addition, all patients received at least 2 weeks of NSAID treatment by the orthopedist. A progressive exercise program was applied to all treatment groups. The progressive exercise program was continued under the supervision of a physiotherapist 2 days a week for 6 weeks. The progressive exercise program consisted of strengthening exercises for the muscles around the knee and hip, stretching exercises for the hamstring and gastrosoleus muscles. The knee orthosis group received the OrthoCare® 6158 Genucare Luxa knee orthosis. T-max Kinesiology Tape® (Tmax Medical Co., South Korea) brand kinesio tape was used in all patients. In kinesio tape application, 2 Y-shaped tapes were used. The activation technique was applied to the VMO muscle with the first band. In the second band, mechanical correction technique was applied to the patella.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome, Patellofemoral Pain, Patellofemoral Syndrome, Orthotic Devices, Kinesiotape

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized controlled single-blind
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio taping group
Arm Type
Experimental
Arm Description
In addition to the standard exercise program, kinesio taping was applied to the knee for 6 weeks.
Arm Title
Orthosis group
Arm Type
Experimental
Arm Description
In addition to the standard exercise program, they were asked to use a knee orthosis for 6 weeks.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
A standard exercise program was applied for 6 weeks.
Intervention Type
Procedure
Intervention Name(s)
Kinesio taping
Intervention Description
A corrective kinesio taping was applied to the patellofemoral joint for the knee. In addition, exercise therapy was taken.
Intervention Type
Procedure
Intervention Name(s)
Orthosis
Intervention Description
They were asked to use a knee orthosis for a minimum of 6 hours a day. They also received exercise therapy.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
An exercise program focused on the knee and hip muscles was given two days a week.
Primary Outcome Measure Information:
Title
Change in baseline Kujala scores of patients treated at week 6
Description
It is a score that evaluates symptoms and function in patients with patellofemoral pain syndrome. Patients were asked to complete this score before starting the treatment and again at the end of the 6-week treatment.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in baseline Visual Analogue Scale of patients treated at week 6
Description
It is a scale that evaluates pain. Patients were asked to complete this scale before starting the treatment and again at the end of the 6-week treatment.
Time Frame
6 weeks
Title
Change in baseline Knee Injury and Osteoarthritis Outcome Score of patients treated at week 6
Description
Knee Injury and Osteoarthritis Outcome Score (KOOS) is a score used to evaluate symptoms and functional status related to knee injury and knee osteoarthritis. Patients were asked to complete this score before starting the treatment and again at the end of the 6-week treatment.
Time Frame
6 weeks
Title
Change in baseline isokinetic strength test of patients treated at week 6
Description
This test is a strength test performed with an isokinetic strength testing machine. This test was applied to the patients before starting the treatment and at the end of the 6-week treatment.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Be between the ages of 18-45 Patients with a body mass index (BMI) less than 29.9 Anterior knee pain defined as 3 points on the 10 cm Visual Analogue Scale when performing at least two activities of sitting for a long time, climbing/descending stairs, squatting, running and jumping Exclusion Criteria: Patients with knee osteoarthritis History of surgery involving the lower extremity Patellar or quadriceps tendinopathy Injury to the meniscus or knee ligaments Patients showing an allergic response to kinesio tape Patients previously treated with PFAS Existing hip pathologies History of patellar subluxation or dislocation Patients with neurological disorders Patients who did not fill out the voluntary consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunus Özdemir, MSc
Organizational Affiliation
Medipol University
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
ZIP/Postal Code
34815
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparing the Effectiveness of Kinesio Taping and Knee Orthosis in Patients With Patellofemoral Pain Syndrome

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