Quality of LifeNCT06534333
Contribution of Ultrasonography in Patellofemoral Pain Syndrome
An observational study of Quality of Life and Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Patellofemoral pain syndrome (PFPS) is a common cause of knee pain in adults younger than 60 years. . In this study, we aimed to evaluate the medial and lateral cartilage thickness the medial and lateral retinaculum thickness and the medial and lateral patellofemoral distance using ultrasonography and to compare with… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Pain
- What is being tested?
- Ultrasonography
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Jul 2024
- Phase
- Observational
- 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
Study population: Group 1: Patients with patellofemoral pain syndrome Group 2: Healthy subjects without knee pain
Who may be able to join
- . The inclusion criteria for the PFPS group were that the patients had knee pain for at least 3 month, unilateral pain, no history of knee surgery, no systemic disease, and no clinical symptoms of other knee pathologies other than PFPS. In order to exclude other pathologies that cause knee pain; patellar plica tests, Apley compression and distraction tests, McMurray tests, varus-valgus stress tests, anterior and posterior drawer tests, pivot shift and Lachman tests were performed. Those with positive results in these tests were excluded from the study.
- The inclusion criteria for the control group were absence of anterior knee pain, no history of knee surgery, and no systemic disease.
Who cannot join
- Individuals with clinical symptoms related to other knee pathologies, history of trauma, history of patellar dislocation or subluxation, passive motion restriction in the knee joint, hip-spine related pain, the presence of any neurological disease affecting the extremities, inflammatory disease were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çorum Erol Olçok Research and Training hospital
Çorum
About this study
Official title: Can Ultrasonography Contribute to the Diagnosis of Patellofemoral Pain Syndrome?
Patellofemoral pain syndrome (PFPS) is a common cause of knee pain in adults younger than 60 years. . In this study, we aimed to evaluate the medial and lateral cartilage thickness the medial and lateral retinaculum thickness and the medial and lateral patellofemoral distance using ultrasonography and to compare with healthy controls. We also aimed to investigate the relationship between the measurements obtained in the PFPS group and pain intensity, functional scoring, and quality of life.
Read the detailed description
Patellofemoral pain syndrome (PFPS) is a common cause of knee pain in adults younger than 60 years. The prevalence of PFPS was found to be 7-28.2% and the incidence was 9.2%. In this study, we aimed to evaluate the medial and lateral cartilage thickness due to the possible relationship of PFPS with osteoarthritis, the medial and lateral retinaculum thickness as it is one of the static stabilizers of the patellofemoral joint, and the medial and lateral patellofemoral distance as it indicates patellar malposition, using ultrasonography and to compare with healthy controls. We also aimed to investigate the relationship between the measurements obtained in the PFPS group and pain intensity, functional scoring, and quality of life.This study is a non-randomized and non-blinded, cross-sectional clinical study with a control group. 54 eligible volunteers who applied to the physical medicine and rehabilitation outpatient clinic of Hitit University Faculty of Medicine.27 of the participants were patients diagnosed with unilateral PFPS, and 27 were healthy individuals without knee pain. Local ethics committee approved the study (2024/36) and informed consent was obtained from all participants.Participants were between the ages of 18-45. A positive result in at least one of the following four tests was considered diagnostic for PFPS, with pain occurring around or behind the patella and aggravated by at least one activity that placed load on the patellofemoral joint during weight bearing on the flexed knee. These tests 1) Medial or lateral patellar facet tenderness 2) Clark's test 3) Patellar apprehension test 4) Patellar tilt test. The inclusion criteria for the PFPS group were that the patients had knee pain for at least 3 month, unilateral pain, no history of knee surgery, no systemic disease, and no clinical symptoms of other knee pathologies other than PFPS. In order to exclude other pathologies that cause knee pain; patellar plica tests, Apley compression and distraction tests, McMurray tests, varus-valgus stress tests, anterior and posterior drawer tests, pivot shift and Lachman tests were performed. Those with positive results in these tests were excluded from the study.
The inclusion criteria for the control group were absence of anterior knee pain, no history of knee surgery, and no systemic disease.
Individuals with clinical symptoms related to other knee pathologies, history of trauma, history of patellar dislocation or subluxation, passive motion restriction in the knee joint, hip-spine related pain, the presence of any neurological disease affecting the extremities, inflammatory disease were excluded.
Detailed history and physical examination findings were recorded. The age, education level, marital status, height, weight, body mass index (kg/m2), duration of pain, dominant and affected extremity of all patients were recorded.
Pain levels at rest and during activity were measured using the Visual Analogue Scale (VAS).Kujala patellofemoral score was used to assess functional status of patients.Quality of life was evaluated with Short form-36 (SF-36). A B-mode ultrasound examination was performed by a radiologist with more than 5 years of experience using a Samsung RS85 Prestige (Medical Systems Corporation, Seoul, South Korea) with a high frequency (4-15 MHz) linear probe.The painful knee of the PFAS group and the non-dominant knee of the control group were evaluated by ultrasonography. The medial and lateral retinaculum thickness, medial femoro-patellar distance from the medial patellar edge to the medial femoral condyle, lateral patellofemoral distance from the lateral patellar edge to the lateral femoral condyle were measured in the axial plane with the patients in the supine position with the knee flexed 30°. The medial and lateral sides of the trochlear cartilage were measured in the axial plane with the knee in 140° flexion.
- Conditions
- Quality of Life, Pain
- Being tested
- Ultrasonography
- Keywords
- patellofemoral pain syndrome, ultrasonography, cartilage,
- Medical subject headings
- Pain, Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyOther
musculoskeletal ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patellofemoral pain syndrome group Receives: Other: Ultrasonography | |
| Group 2 | Control group Receives: Other: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
trochlear cartilage thickness
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Apr 2024
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Handan Elif Nur BAYRAKTAR, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534333
- Sponsor's protocol ID
- Erololçok-dk-1
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pacini P, Martino M, Giuliani L, Santilli G, Agostini F, Del Gaudio G, Bernetti A, Mangone M, Paoloni M, Toscano M, De Vito C, Ottonello C, Santilli V, Cantisani V. Patello-Femoral Pain Syndrome: Magnetic Resonance Imaging versus Ultrasound. Diagnostics (Basel). 2023 Apr 21;13(8):1496. doi: 10.3390/diagnostics13081496.
PubMed 37189597Crossley KM, Stefanik JJ, Selfe J, Collins NJ, Davis IS, Powers CM, McConnell J, Vicenzino B, Bazett-Jones DM, Esculier JF, Morrissey D, Callaghan MJ. 2016 Patellofemoral pain consensus statement from the 4th International Patellofemoral Pain Research Retreat, Manchester. Part 1: Terminology, definitions, clinical examination, natural history, patellofemoral osteoarthritis and patient-reported outcome measures. Br J Sports Med. 2016 Jul;50(14):839-43. doi: 10.1136/bjsports-2016-096384. Epub 2016 Jun 24. No abstract available.
PubMed 27343241
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Ultrasonography Contribute to the Diagnosis of Patellofemoral Pain Syndrome?
- ClinicalTrials.gov ID
- NCT06534333
- Acronym / sponsor ID
- Erololçok-dk-1
- Conditions
- Quality of Life, Pain
- Keywords
- patellofemoral pain syndrome, ultrasonography, cartilage,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 2 Aug 2024 (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.
Patellofemoral pain syndrome (PFPS) is a common cause of knee pain in adults younger than 60 years. . In this study, we aimed to evaluate the medial and lateral cartilage thickness the medial and lateral retinaculum thickness and the medial and lateral patellofemoral distance using ultrasonography and to compare with healthy controls. We also aimed to investigate the relationship between the measurements obtained in the PFPS group and pain intensity, functional scoring, and quality of life.
Detailed description
Patellofemoral pain syndrome (PFPS) is a common cause of knee pain in adults younger than 60 years. The prevalence of PFPS was found to be 7-28.2% and the incidence was 9.2%. In this study, we aimed to evaluate the medial and lateral cartilage thickness due to the possible relationship of PFPS with osteoarthritis, the medial and lateral retinaculum thickness as it is one of the static stabilizers of the patellofemoral joint, and the medial and lateral patellofemoral distance as it indicates patellar malposition, using ultrasonography and to compare with healthy controls. We also aimed to investigate the relationship between the measurements obtained in the PFPS group and pain intensity, functional scoring, and quality of life.This study is a non-randomized and non-blinded, cross-sectional clinical study with a control group. 54 eligible volunteers who applied to the physical medicine and rehabilitation outpatient clinic of Hitit University Faculty of Medicine.27 of the participants were patients diagnosed with unilateral PFPS, and 27 were healthy individuals without knee pain. Local ethics committee approved the study (2024/36) and informed consent was obtained from all participants.Participants were between the ages of 18-45. A positive result in at least one of the following four tests was considered diagnostic for PFPS, with pain occurring around or behind the patella and aggravated by at least one activity that placed load on the patellofemoral joint during weight bearing on the flexed knee. These tests 1) Medial or lateral patellar facet tenderness 2) Clark's test 3) Patellar apprehension test 4) Patellar tilt test. The inclusion criteria for the PFPS group were that the patients had knee pain for at least 3 month, unilateral pain, no history of knee surgery, no systemic disease, and no clinical symptoms of other knee pathologies other than PFPS. In order to exclude other pathologies that cause knee pain; patellar plica tests, Apley compression and distraction tests, McMurray tests, varus-valgus stress tests, anterior and posterior drawer tests, pivot shift and Lachman tests were performed. Those with positive results in these tests were excluded from the study.
The inclusion criteria for the control group were absence of anterior knee pain, no history of knee surgery, and no systemic disease.
Individuals with clinical symptoms related to other knee pathologies, history of trauma, history of patellar dislocation or subluxation, passive motion restriction in the knee joint, hip-spine related pain, the presence of any neurological disease affecting the extremities, inflammatory disease were excluded.
Detailed history and physical examination findings were recorded. The age, education level, marital status, height, weight, body mass index (kg/m2), duration of pain, dominant and affected extremity of all patients were recorded.
Pain levels at rest and during activity were measured using the Visual Analogue Scale (VAS).Kujala patellofemoral score was used to assess functional status of patients.Quality of life was evaluated with Short form-36 (SF-36). A B-mode ultrasound examination was performed by a radiologist with more than 5 years of experience using a Samsung RS85 Prestige (Medical Systems Corporation, Seoul, South Korea) with a high frequency (4-15 MHz) linear probe.The painful knee of the PFAS group and the non-dominant knee of the control group were evaluated by ultrasonography. The medial and lateral retinaculum thickness, medial femoro-patellar distance from the medial patellar edge to the medial femoral condyle, lateral patellofemoral distance from the lateral patellar edge to the lateral femoral condyle were measured in the axial plane with the patients in the supine position with the knee flexed 30°. The medial and lateral sides of the trochlear cartilage were measured in the axial plane with the knee in 140° flexion.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: UltrasonographyPatellofemoral pain syndrome group |
| Group 2 | – | Other: UltrasonographyControl group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Group 1: Patients with patellofemoral pain syndrome Group 2: Healthy subjects without knee pain
Key inclusion criteria (2 listed)
- . The inclusion criteria for the PFPS group were that the patients had knee pain for at least 3 month, unilateral pain, no history of knee surgery, no systemic disease, and no clinical symptoms of other knee pathologies other than PFPS. In order to exclude other pathologies that cause knee pain; patellar plica tests, Apley compression and distraction tests, McMurray tests, varus-valgus stress tests, anterior and posterior drawer tests, pivot shift and Lachman tests were performed. Those with positive results in these tests were excluded from the study.
- The inclusion criteria for the control group were absence of anterior knee pain, no history of knee surgery, and no systemic disease.
Key exclusion criteria (1 listed)
- Individuals with clinical symptoms related to other knee pathologies, history of trauma, history of patellar dislocation or subluxation, passive motion restriction in the knee joint, hip-spine related pain, the presence of any neurological disease affecting the extremities, inflammatory disease were excluded.
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 |
|---|---|---|
| Ultrasonographymusculoskeletal ultrasonography | Other | Group 1, Group 2 |
Primary outcome
trochlear cartilage thickness
Time frame: three months
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 2 Aug 2024.
- Background: PubMed 37189597Pacini P, Martino M, Giuliani L, Santilli G, Agostini F, Del Gaudio G, Bernetti A, Mangone M, Paoloni M, Toscano M, De Vito C, Ottonello C, Santilli V, Cantisani V. Patello-Femoral Pain Syndrome: Magnetic Resonance Imaging versus Ultrasound. Diagnostics (Basel). 2023 Apr 21;13(8):1496. doi: 10.3390/diagnostics13081496.
- Background: PubMed 27343241Crossley KM, Stefanik JJ, Selfe J, Collins NJ, Davis IS, Powers CM, McConnell J, Vicenzino B, Bazett-Jones DM, Esculier JF, Morrissey D, Callaghan MJ. 2016 Patellofemoral pain consensus statement from the 4th International Patellofemoral Pain Research Retreat, Manchester. Part 1: Terminology, definitions, clinical examination, natural history, patellofemoral osteoarthritis and patient-reported outcome measures. Br J Sports Med. 2016 Jul;50(14):839-43. doi: 10.1136/bjsports-2016-096384. Epub 2016 Jun 24. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Pain, run by Ankara City Hospital Bilkent 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 2 inclusion and 1 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 2 Aug 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?
trochlear cartilage thickness (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06534333, which also lists 2 linked publications.
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 2 Aug 2024.