Patello Femoral SyndromeNCT04760158
Comparison of New Technique Taping and Placebo Taping on Patellofemoral Pain Syndrome: A Randomised Controlled Study
A study testing Exercise in people with Patello Femoral Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
We included in this study 42 individuals with patellofemoral pain syndrome. 39 of them were completed six weeks of exercise and other groups. We randomized them into three groups. One group is the star technique which is a new patellar taping technique. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patello Femoral Syndrome
- What is being tested?
- Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2019to 20 Jan 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- insidious onset of anterior knee pain with a duration greater than 4 weeks;
- self-reported patellofemoral pain intensity ≥30 mm on the 100 mm Visual Analogue Scale (VAS)
- pain provoked by at least two of the following situations: prolonged sitting or kneeling, squatting, running, hopping, or ascending or descending stairs;
- age ranged between 18-60 years.
Who cannot join
- the clinical history of patellofemoral dislocation or subluxation; knee osteoarthritis; injury or pain from the hip, lumbar spine, or other knee structures (meniscus, ligaments, bursa, synovial plica, infrapatellar fat)
- -); traumatic lesions of soft tissues or previous orthopedic surgery in lower limbs; having received knee injections of corticosteroids or hyaluronic acid
- cognition or impaired communication
- being involved in an ongoing medical-legal dispute
- using Canadien or walker; can not walk independently
- having an allergy to taping
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University
Kirikkale, Yahşihan, 71140
About this study
Official title: New Technique For Taping on Patellofemoral Pain Syndrome
We included in this study 42 individuals with patellofemoral pain syndrome. 39 of them were completed six weeks of exercise and other groups. We randomized them into three groups. One group is the star technique which is a new patellar taping technique. Another group is placebo taping and the third group is only the exercise group. Both groups performed exercises three times a week for six weeks. Three groups were assessed with knee and hip muscles strength, shortness, performance tests, pain severity in the activity, night, rest, and knee-buckling, and Kujala Scale before and after 4-week exercises.
Read the detailed description
Based on previous studies those participants who met the following inclusion criteria were invited to participate in the study: i) insidious onset of anterior knee pain with a duration greater than 4 weeks; ii) pain provoked by at least two of the following situations: prolonged sitting or kneeling, squatting, running, hopping or ascending or descending stairs; iii) age ranged between 18-60 years.
Participants were excluded in cases of the clinical history of patellofemoral dislocation or subluxation; knee osteoarthritis; injury or pain from the hip, lumbar spine, or other knee structures (meniscus, ligaments, bursa, synovial plica, infrapatellar fat); traumatic lesions of soft tissues or previous orthopedic surgery in lower limbs; having received knee injections of corticosteroids or hyaluronic acid; cognition or impaired communication; being involved in an ongoing medical-legal dispute; using Canadien or walker; can not walk independently and having an allergy to taping.
- Conditions
- Patello Femoral Syndrome
- Being tested
- Exercise
- Keywords
- Patella Femoral Pain Syndrome, Exercise, Elastic taping, Pain, Kinesiotaping
- Medical subject headings
- Patellofemoral Pain Syndrome, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Participants of this study exercised strengthening and stretching 3 days a week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Taping group | Experimental | A new star taping technique and exercises were applied to participants. Receives: Other: Exercise |
| Sham Taping Group | Sham comparator | Sham patellar taping and exercises were applied to participants. Receives: Other: Exercise |
| control group | Other | Only exercises were applied to participants. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparision of the effects of new patellar taping technique and placebo taping on performance
we analyzed and compared the performance test outcomes.
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 posted18 Feb 2021
- Study start5 Jun 2019
- Primary completion10 Dec 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patello Femoral SyndromeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tezel Yıldırım Şahan, Hacettepe University
- Investigators
- Tezel Y Şahan, Principal investigator, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760158
- Sponsor's protocol ID
- 2014/06/02
- Status last verified
- Feb 2021
- First submitted
- 16 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Technique For Taping on Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT04760158
- Acronym / sponsor ID
- 2014/06/02
- Conditions
- Patello Femoral Syndrome
- Keywords
- Patella Femoral Pain Syndrome, Exercise, Elastic taping, Pain, Kinesiotaping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 18 Feb 2021 (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.
We included in this study 42 individuals with patellofemoral pain syndrome. 39 of them were completed six weeks of exercise and other groups. We randomized them into three groups. One group is the star technique which is a new patellar taping technique. Another group is placebo taping and the third group is only the exercise group. Both groups performed exercises three times a week for six weeks. Three groups were assessed with knee and hip muscles strength, shortness, performance tests, pain severity in the activity, night, rest, and knee-buckling, and Kujala Scale before and after 4-week exercises.
Detailed description
Based on previous studies those participants who met the following inclusion criteria were invited to participate in the study: i) insidious onset of anterior knee pain with a duration greater than 4 weeks; ii) pain provoked by at least two of the following situations: prolonged sitting or kneeling, squatting, running, hopping or ascending or descending stairs; iii) age ranged between 18-60 years.
Participants were excluded in cases of the clinical history of patellofemoral dislocation or subluxation; knee osteoarthritis; injury or pain from the hip, lumbar spine, or other knee structures (meniscus, ligaments, bursa, synovial plica, infrapatellar fat); traumatic lesions of soft tissues or previous orthopedic surgery in lower limbs; having received knee injections of corticosteroids or hyaluronic acid; cognition or impaired communication; being involved in an ongoing medical-legal dispute; using Canadien or walker; can not walk independently and having an allergy to taping.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Taping group | Experimental | Other: ExerciseA new star taping technique and exercises were applied to participants. |
| Sham Taping Group | Sham comparator | Other: ExerciseSham patellar taping and exercises were applied to participants. |
| control group | Other | Other: ExerciseOnly exercises were applied to participants. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- insidious onset of anterior knee pain with a duration greater than 4 weeks;
- self-reported patellofemoral pain intensity ≥30 mm on the 100 mm Visual Analogue Scale (VAS)
- pain provoked by at least two of the following situations: prolonged sitting or kneeling, squatting, running, hopping, or ascending or descending stairs;
- age ranged between 18-60 years.
Key exclusion criteria (6 listed)
- the clinical history of patellofemoral dislocation or subluxation; knee osteoarthritis; injury or pain from the hip, lumbar spine, or other knee structures (meniscus, ligaments, bursa, synovial plica, infrapatellar fat)
- -); traumatic lesions of soft tissues or previous orthopedic surgery in lower limbs; having received knee injections of corticosteroids or hyaluronic acid
- cognition or impaired communication
- being involved in an ongoing medical-legal dispute
- using Canadien or walker; can not walk independently
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 |
|---|---|---|
| ExerciseParticipants of this study exercised strengthening and stretching 3 days a week for 6 weeks | Other | Sham Taping Group, Taping group, control group |
Primary outcome
comparision of the effects of new patellar taping technique and placebo taping on performance
Time frame: 6 weeks
we analyzed and compared the performance test outcomes.
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 18 Feb 2021.
- Effects of exercise combined with whole body vibration in patients with patellofemoral pain syndrome: a randomised-controlled clinical trial. BMC Musculoskelet Disord 21, 582 (2020).Link provided by the sponsor.
- Systematic Review of the Effect of Taping Techniques on Patellofemoral Pain SyndromeLink provided by the sponsor.
- The Effect of Kinesio Taping on Anterior Knee Pain Consistent With Patellofemoral Pain Syndrome: A Critically Appraised TopicLink provided by the sponsor.
- Effects of Posterior X Taping on Movement Quality and Knee Pain Intensity during Forward-Step-Down in Patients with Patellofemoral Pain SyndromeLink provided by the sponsor.
- 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.
Tezel Y Şahan principal investigator
Kırıkkale 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 Exercise in people with Patello Femoral Syndrome, run by Hacettepe University 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 4 inclusion and 6 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 18 Feb 2021. 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. Some participants in this study may receive a placebo. 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?
comparision of the effects of new patellar taping technique and placebo taping on performance (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 18 Feb 2021.