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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05995210
Other study ID # IstanbulMUH-DPTR-Yozdemir-0859
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 9, 2021
Est. completion date June 16, 2023

Study information

Verified date August 2023
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 OrthoCareĀ® 6158 Genucare Luxa knee orthosis. T-max Kinesiology TapeĀ® (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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date June 16, 2023
Est. primary completion date May 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

Procedure:
Kinesio taping
A corrective kinesio taping was applied to the patellofemoral joint for the knee. In addition, exercise therapy was taken.
Orthosis
They were asked to use a knee orthosis for a minimum of 6 hours a day. They also received exercise therapy.
Control
An exercise program focused on the knee and hip muscles was given two days a week.

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 weeks
Secondary 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. 6 weeks
Secondary 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. 6 weeks
Secondary 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. 6 weeks
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