Patellofemoral Pain SyndromeNCT05995210
Comparing the Effectiveness of Kinesio Taping and Knee Orthosis in Patients with Patellofemoral Pain Syndrome
A study testing Kinesio taping and Orthosis in people with Patellofemoral Pain Syndrome and Anterior Knee Pain Syndrome, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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)… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome, Patellofemoral Pain
- What is being tested?
- Kinesio taping and Orthosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Dec 2021to 16 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Existing hip pathologies
- History of patellar subluxation or dislocation
- Patients with neurological disorders
- Patients who did not fill out the voluntary consent form
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Istanbul, 34815
About this study
Official title: 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.
Read the 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.
- Conditions
- Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome, Patellofemoral Pain, Patellofemoral Syndrome, Orthotic Devices, Kinesiotape
- Being tested
- Kinesio taping, Orthosis, Control
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapingProcedure or surgery
A corrective kinesio taping was applied to the patellofemoral joint for the knee. In addition, exercise therapy was taken.
OrthosisProcedure or surgery
They were asked to use a knee orthosis for a minimum of 6 hours a day. They also received exercise therapy.
ControlProcedure or surgery
An exercise program focused on the knee and hip muscles was given two days a week.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio taping group | Experimental | In addition to the standard exercise program, kinesio taping was applied to the knee for 6 weeks. Receives: Procedure: Kinesio taping; Procedure: Control |
| Orthosis group | Experimental | In addition to the standard exercise program, they were asked to use a knee orthosis for 6 weeks. Receives: Procedure: Orthosis; Procedure: Control |
| Control group | Active comparator | A standard exercise program was applied for 6 weeks. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (3)
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start9 Dec 2021
- Primary completion5 May 2023
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized controlled single-blind
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Özdemir, PhD, Istanbul Medipol University Hospital
- Investigators
- Yunus Özdemir, MSc, Study chair, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995210
- Sponsor's protocol ID
- IstanbulMUH-DPTR-Yozdemir-0859
- Status last verified
- Sep 2024
- First submitted
- 3 Jul 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Kinesio Taping and Knee Orthosis in Patients with Patellofemoral Pain Syndrome: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05995210
- Acronym / sponsor ID
- IstanbulMUH-DPTR-Yozdemir-0859
- Conditions
- Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome, Patellofemoral Pain, Patellofemoral Syndrome, Orthotic Devices, Kinesiotape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- prospective randomized controlled single-blind
| Arm | Type | Receives |
|---|---|---|
| Kinesio taping group | Experimental | Procedure: Kinesio taping, Procedure: ControlIn addition to the standard exercise program, kinesio taping was applied to the knee for 6 weeks. |
| Orthosis group | Experimental | Procedure: Orthosis, Procedure: ControlIn addition to the standard exercise program, they were asked to use a knee orthosis for 6 weeks. |
| Control group | Active comparator | Procedure: ControlA standard exercise program was applied for 6 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio tapingA corrective kinesio taping was applied to the patellofemoral joint for the knee. In addition, exercise therapy was taken. | Procedure or surgery | Kinesio taping group |
| OrthosisThey were asked to use a knee orthosis for a minimum of 6 hours a day. They also received exercise therapy. | Procedure or surgery | Orthosis group |
| ControlAn exercise program focused on the knee and hip muscles was given two days a week. | Procedure or surgery | Control group, Kinesio taping group, Orthosis group |
Primary outcome
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.
3 secondary outcomes
Change in baseline Visual Analogue Scale of patients treated at week 6
Time frame: 6 weeks
Change in baseline Knee Injury and Osteoarthritis Outcome Score of patients treated at week 6
Time frame: 6 weeks
Change in baseline isokinetic strength test of patients treated at week 6
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunus Özdemir, MSc study chair
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio taping and Orthosis in people with Patellofemoral Pain Syndrome and Anterior Knee Pain Syndrome, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 10 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 19 Sep 2024. 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 Turkey (Türkiye). 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?
Change in baseline Kujala scores of patients treated at week 6 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.