- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05995210
Comparing the Effectiveness of Kinesio Taping and Knee Orthosis in Patients with Patellofemoral Pain Syndrome
September 12, 2024 updated by: Yunus Özdemir, PhD, Istanbul Medipol University Hospital
Comparing the Effectiveness of Kinesio Taping and Knee Orthosis in Patients with Patellofemoral Pain Syndrome: a Randomized Controlled Study
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) and isokinetic strength test (IST) were used in the evaluation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
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.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34815
- İstanbul Medipol University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kinesio taping group
In addition to the standard exercise program, kinesio taping was applied to the knee for 6 weeks.
|
A corrective kinesio taping was applied to the patellofemoral joint for the knee.
In addition, exercise therapy was taken.
An exercise program focused on the knee and hip muscles was given two days a week.
|
|
Experimental: Orthosis group
In addition to the standard exercise program, they were asked to use a knee orthosis for 6 weeks.
|
An exercise program focused on the knee and hip muscles was given two days a week.
They were asked to use a knee orthosis for a minimum of 6 hours a day.
They also received exercise therapy.
|
|
Active Comparator: Control group
A standard exercise program was applied for 6 weeks.
|
An exercise program focused on the knee and hip muscles was given two days a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in baseline Kujala scores of patients treated at week 6
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in baseline Visual Analogue Scale of patients treated at week 6
Time Frame: 6 weeks
|
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.
|
6 weeks
|
|
Change in baseline Knee Injury and Osteoarthritis Outcome Score of patients treated at week 6
Time Frame: 6 weeks
|
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.
|
6 weeks
|
|
Change in baseline isokinetic strength test of patients treated at week 6
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Yunus Özdemir, MSc, Medipol University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 9, 2021
Primary Completion (Actual)
May 5, 2023
Study Completion (Actual)
June 16, 2023
Study Registration Dates
First Submitted
July 3, 2023
First Submitted That Met QC Criteria
August 9, 2023
First Posted (Actual)
August 16, 2023
Study Record Updates
Last Update Posted (Actual)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 12, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulMUH-DPTR-Yozdemir-0859
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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