Patellofemoral SyndromeNCT05303610
Effects of Tissue Properties of the Superficial Anterior Myofascial Chain on the Development of Patellofemoral Pain Syndrome
An observational study of Patellofemoral Syndrome and Knee, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate the myofascial chain lines in addition to the general evaluation parameters in patients with patellofemoral pain syndrome (PFPS) and to determine whether deviations from normal in the myofascial structure have an effect on the development of PFPS. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Patellofemoral Syndrome, Knee, Connective Tissue
- What is being tested?
- Observational
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2022to 3 Jun 2023
- 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 25 to 50 years
- All sexes
- Adult
Study population: Persons who meet the inclusion criteria and who volunteered to participate in the study, who applied to the Orthopaedic outpatient clinic of the Medical Faculty Hospital will be included in the study.
Who may be able to join
- Diagnosed with Patellofemoral pain syndrome,
- Volunteers between the ages of 25-50,
- Having pain in the retropatellar region for at least 6 months that is not a result of trauma,
- Not having received medical treatment and/or physiotherapy for PFPS in the last 6 months.
Who cannot join
- Having history of lower extremity, pelvis and spine surgery/fracture in the last 6 months,
- Having orthopedic (Anterior cruciate ligament rupture, Meniscal tears, etc), neurological (Multiple sclerosis, paralysis-paralysis, etc.) and/or rheumatological (rheumatoid arthritis, ankylosing spondolitis, etc.) problems,
- Pregnancy ,
- Having a history of connective tissue disease,
- Using sedatives and/or muscle relaxants that may alter muscle tone.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the myofascial chain lines in addition to the general evaluation parameters in patients with patellofemoral pain syndrome (PFPS) and to determine whether deviations from normal in the myofascial structure have an effect on the development of PFPS.
There will be two groups in this study. One of the groups will consist of 28 patients aged between 25-50 years. The other group will consist of 28 healthy individuals between the ages of 25-50 years. Postural problems that can be seen in the superficial anterior myofascial chain line will be evaluated. These problems: forward head, q-angle, genu varum, genu valgum, foot postural problems (pes planus, pes kavus vb.) and pelvic tilt. In addition to all these assessments, knee pain and the biomechanical properties of the anterior myofascial tissue will be evaluated.
Read the detailed description
Although many factors such as lower extremity malalignment, quadriceps muscle weakness, hamstring, gastrocnemius, tensor fascia latae muscle shortness, iliotibial band tension, lower extremity malalignment have been shown to be effective in the development of PFPS, it has been reported in recent studies that these factors which cause patellofemoral pain syndrome may also be related to fascia. The aim of the study is to evaluate the myofascial chain lines in addition to the general evaluation parameters in patients with patellofemoral pain syndrome (PFPS) and to determine whether deviations from normal in the myofascial structure have an effect on the development of PFPS. It was stated that the fascial chain containing the PFPS-related regions is the Superficial Anterior Chain, and this chain starts from the toe extensors and ends at the masteoid process.
There will be two groups in this study. One group of this study will include 28 individuals aged 25-50, diagnosed with PFPS, with pain in the retropatellar region for at least 6 months and non-traumatic. The other group of this study will include 28 healthy individuals between the ages of 25-50 and without any orthopedic (Anterior cruciate ligament rupture, Meniscal tears etc.), neurological (Multipl sclerosis, Stroke etc) and rheumatological disorders (Rheumatoid arthritis, Ankylosing spondylitis etc.).
Postural problems that can be seen in the superficial anterior myofascial chain line will be evaluated. These problems: forward head, q-angle, genu varum, genu valgum, foot postural problems (pes planus, pes kavus vb.) and pelvic tilt. In addition to all these assessments, knee pain and the biomechanical properties of the anterior myofascial tissue will be evaluated.
- Conditions
- Patellofemoral Syndrome, Knee, Connective Tissue, Fascia
- Being tested
- Observational
- Keywords
- Patellofemoral Syndrome, knee, connective tissue, fascia
- 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.
ObservationalOther
This is a cross sectional study. The aim of the study is to evaluate the myofascial chain lines in addition to the general evaluation parameters in patients with patellofemoral pain syndrome (PFPS) and to determine whether deviations from normal in the myofascial structure have an effect on the development of PFPS.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | This group will consist of 28 patients with diagnosed Patellofemoral pain syndrome, aged between 25-50 years. Receives: Other: Observational | |
| Control group | Healthy individuals between the ages of 25-50 and without any orthopedic (Anterior cruciate ligament rupture, Meniscal tears etc.), neurological (Multipl sclerosis, Stroke etc) and rheumatological disorders (Rheumatoid arthritis, Ankylosing spondylitis etc.). Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain
Visual Analogue Scale (VAS) will be used in the assessment of pain severity. VAS expresses pain severity between a score of 0 (no pain) and 10 (unbearably severe pain). The subject is asked to mark the score that best reflects the severity of knee pain he/she feels.
Measured: baseline
Forward head
The end point of the superficial anterior myofascial chain considered in the study is the mastoid process. And to this point attach muscles such as the sternocleidomastoid (SCM) that affect head and neck movements and position. In case of shortness of these muscles, forward tilt of the head may occur. The craniovertebral angle will be considered in determining the forward tilt of the head. In this study, markers will be placed on the mastoid process and C7 spinous process to determine the craniovertebral angle. Photographs of the individual will be taken from the front and side, and then the craniovertebral angle will be calculated using the Tracker 4.11.0 software on these photos. FHP is characterized as pathologic when the craniovertebral angle (CVA) is ≥50°.
Measured: baseline
Q-Angle
For the Q angle, the angle between a straight line from the SIAS to the center of the patella and the line from the center of the patella to the center of the tuberositas tibia will be measured with a goniometer. While the Q angle can be between 6° and 27°, its approximate average value is 15°. Increasing or decreasing the Q angle increases the pressure in the lateral and medial compartments of the patellofemoral joint.
4- Genu varum
Measured: baseline
Genu varum
The individual in the standing position is asked to unite the lower extremities while maintaining 0° extension of the knees. The distance between the medial condyles is measured as the medial malleolar are in contact. If the distance is more than 1 cm, it indicates the genu varum.
Measured: baseline
genu valgum
The individual in the standing position is asked to unite the lower extremities while maintaining 0° extension of the knees. The distance between the medial malleolar is measured as the medial condyles are in contact. If the distance is more than 1 cm, it indicates the genu valgum.
Measured: baseline
pes planus
Pes Planus will be evaluated with navicular drop test. The distance between the navicular bone and the ground is measured while the individual sits on the chair with the hip-knee joint in 90º flexion and the subtalar joint in neutral position. Then, the distance between the navicular bone and the ground is measured again while the individual is standing in a position with equal weight on both extremities. The difference between the two measurements is recorded. 10 mm or more difference is considered pes planus.
Measured: baseline
foot posture
Foot posture will be evaluated using the Foot posture index, a six item foot posture assessment tool, where each item is scored between -2 and +2 to give a sum total between -12 (highly supinated) and +12 (highly pronated). Items include: talar head palpation, curves above and below the lateral malleoli, calcaneal angle, talonavicular bulge, medial longitudinal arch, and forefoot to rearfoot alignment.
Measured: baseline
pelvic tilt
The position of the pelvis will be evaluated with a digital pelvic inclinometer device to determine whether the pelvis has tilted anteriorly or posteriorly. The digital pelvic inclinometer is a valid and reliable method for the evaluation of pelvic tilt. The device consists of two calipers and the calipers are placed on the SIAS (spina illaca anterior posterior) and SIPS (spina illaca posterior superior) of the pelvis. The score on the digital display is recorded. "-" values indicate posterior pelvic tilt, "+" values indicate anterior pelvic tilt.
Measured: baseline
Biomechanical and viscoelastic properties of myofascial tissues
Biomechanical and viscoelastic properties of myofascial tissues will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). The passive tone and stiffness properties will be calculated by the device from the average of the oscillatory responses of the tissue to this mechanical stimulus. Measurements were taken 3 times from each point and the average values will be used in statistical analysis
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start20 Sep 2022 (estimated)
- Primary completion5 May 2023 (estimated)
- Study completion3 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Mete, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303610
- Sponsor's protocol ID
- 2022/0077
- Status last verified
- Mar 2022
- First submitted
- 22 Mar 2022
- Last updated
- 24 Aug 2022
- Results posted
- 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 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tissue Properties of the Superficial Anterior Myofascial Chain on the Development of Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT05303610
- Acronym / sponsor ID
- 2022/0077
- Conditions
- Patellofemoral Syndrome, Knee, Connective Tissue, Fascia
- Keywords
- Patellofemoral Syndrome, knee, connective tissue, fascia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 20 Sep 2022 (estimated)
- Primary completion
- 5 May 2023 (estimated)
- Study completion
- 3 Jun 2023 (estimated)
- First posted
- 31 Mar 2022 (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 evaluate the myofascial chain lines in addition to the general evaluation parameters in patients with patellofemoral pain syndrome (PFPS) and to determine whether deviations from normal in the myofascial structure have an effect on the development of PFPS.
There will be two groups in this study. One of the groups will consist of 28 patients aged between 25-50 years. The other group will consist of 28 healthy individuals between the ages of 25-50 years. Postural problems that can be seen in the superficial anterior myofascial chain line will be evaluated. These problems: forward head, q-angle, genu varum, genu valgum, foot postural problems (pes planus, pes kavus vb.) and pelvic tilt. In addition to all these assessments, knee pain and the biomechanical properties of the anterior myofascial tissue will be evaluated.
Detailed description
Although many factors such as lower extremity malalignment, quadriceps muscle weakness, hamstring, gastrocnemius, tensor fascia latae muscle shortness, iliotibial band tension, lower extremity malalignment have been shown to be effective in the development of PFPS, it has been reported in recent studies that these factors which cause patellofemoral pain syndrome may also be related to fascia. The aim of the study is to evaluate the myofascial chain lines in addition to the general evaluation parameters in patients with patellofemoral pain syndrome (PFPS) and to determine whether deviations from normal in the myofascial structure have an effect on the development of PFPS. It was stated that the fascial chain containing the PFPS-related regions is the Superficial Anterior Chain, and this chain starts from the toe extensors and ends at the masteoid process.
There will be two groups in this study. One group of this study will include 28 individuals aged 25-50, diagnosed with PFPS, with pain in the retropatellar region for at least 6 months and non-traumatic. The other group of this study will include 28 healthy individuals between the ages of 25-50 and without any orthopedic (Anterior cruciate ligament rupture, Meniscal tears etc.), neurological (Multipl sclerosis, Stroke etc) and rheumatological disorders (Rheumatoid arthritis, Ankylosing spondylitis etc.).
Postural problems that can be seen in the superficial anterior myofascial chain line will be evaluated. These problems: forward head, q-angle, genu varum, genu valgum, foot postural problems (pes planus, pes kavus vb.) and pelvic tilt. In addition to all these assessments, knee pain and the biomechanical properties of the anterior myofascial tissue will be evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Other: ObservationalThis group will consist of 28 patients with diagnosed Patellofemoral pain syndrome, aged between 25-50 years. |
| Control group | – | Other: ObservationalHealthy individuals between the ages of 25-50 and without any orthopedic (Anterior cruciate ligament rupture, Meniscal tears etc.), neurological (Multipl sclerosis, Stroke etc) and rheumatological disorders (Rheumatoid arthritis, Ankylosing spondylitis etc.). |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Persons who meet the inclusion criteria and who volunteered to participate in the study, who applied to the Orthopaedic outpatient clinic of the Medical Faculty Hospital will be included in the study.
Key inclusion criteria (4 listed)
- Diagnosed with Patellofemoral pain syndrome,
- Volunteers between the ages of 25-50,
- Having pain in the retropatellar region for at least 6 months that is not a result of trauma,
- Not having received medical treatment and/or physiotherapy for PFPS in the last 6 months.
Key exclusion criteria (5 listed)
- Having history of lower extremity, pelvis and spine surgery/fracture in the last 6 months,
- Having orthopedic (Anterior cruciate ligament rupture, Meniscal tears, etc), neurological (Multiple sclerosis, paralysis-paralysis, etc.) and/or rheumatological (rheumatoid arthritis, ankylosing spondolitis, etc.) problems,
- Pregnancy ,
- Having a history of connective tissue disease,
- Using sedatives and/or muscle relaxants that may alter muscle tone.
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 |
|---|---|---|
| ObservationalThis is a cross sectional study. The aim of the study is to evaluate the myofascial chain lines in addition to the general evaluation parameters in patients with patellofemoral pain syndrome (PFPS) and to determine whether deviations from normal in the myofascial structure have an effect on the development of PFPS. | Other | Control group, Experimental group |
Primary outcome
Knee pain
Time frame: baseline
Visual Analogue Scale (VAS) will be used in the assessment of pain severity. VAS expresses pain severity between a score of 0 (no pain) and 10 (unbearably severe pain). The subject is asked to mark the score that best reflects the severity of knee pain he/she feels.
Forward head
Time frame: baseline
The end point of the superficial anterior myofascial chain considered in the study is the mastoid process. And to this point attach muscles such as the sternocleidomastoid (SCM) that affect head and neck movements and position. In case of shortness of these muscles, forward tilt of the head may occur. The craniovertebral angle will be considered in determining the forward tilt of the head. In this study, markers will be placed on the mastoid process and C7 spinous process to determine the craniovertebral angle. Photographs of the individual will be taken from the front and side, and then the craniovertebral angle will be calculated using the Tracker 4.11.0 software on these photos. FHP is characterized as pathologic when the craniovertebral angle (CVA) is ≥50°.
Q-Angle
Time frame: baseline
For the Q angle, the angle between a straight line from the SIAS to the center of the patella and the line from the center of the patella to the center of the tuberositas tibia will be measured with a goniometer. While the Q angle can be between 6° and 27°, its approximate average value is 15°. Increasing or decreasing the Q angle increases the pressure in the lateral and medial compartments of the patellofemoral joint. 4- Genu varum
Genu varum
Time frame: baseline
The individual in the standing position is asked to unite the lower extremities while maintaining 0° extension of the knees. The distance between the medial condyles is measured as the medial malleolar are in contact. If the distance is more than 1 cm, it indicates the genu varum.
genu valgum
Time frame: baseline
The individual in the standing position is asked to unite the lower extremities while maintaining 0° extension of the knees. The distance between the medial malleolar is measured as the medial condyles are in contact. If the distance is more than 1 cm, it indicates the genu valgum.
pes planus
Time frame: baseline
Pes Planus will be evaluated with navicular drop test. The distance between the navicular bone and the ground is measured while the individual sits on the chair with the hip-knee joint in 90º flexion and the subtalar joint in neutral position. Then, the distance between the navicular bone and the ground is measured again while the individual is standing in a position with equal weight on both extremities. The difference between the two measurements is recorded. 10 mm or more difference is considered pes planus.
foot posture
Time frame: baseline
Foot posture will be evaluated using the Foot posture index, a six item foot posture assessment tool, where each item is scored between -2 and +2 to give a sum total between -12 (highly supinated) and +12 (highly pronated). Items include: talar head palpation, curves above and below the lateral malleoli, calcaneal angle, talonavicular bulge, medial longitudinal arch, and forefoot to rearfoot alignment.
pelvic tilt
Time frame: baseline
The position of the pelvis will be evaluated with a digital pelvic inclinometer device to determine whether the pelvis has tilted anteriorly or posteriorly. The digital pelvic inclinometer is a valid and reliable method for the evaluation of pelvic tilt. The device consists of two calipers and the calipers are placed on the SIAS (spina illaca anterior posterior) and SIPS (spina illaca posterior superior) of the pelvis. The score on the digital display is recorded. "-" values indicate posterior pelvic tilt, "+" values indicate anterior pelvic tilt.
Biomechanical and viscoelastic properties of myofascial tissues
Time frame: baseline
Biomechanical and viscoelastic properties of myofascial tissues will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). The passive tone and stiffness properties will be calculated by the device from the average of the oscillatory responses of the tissue to this mechanical stimulus. Measurements were taken 3 times from each point and the average values will be used in statistical analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- 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.
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 Patellofemoral Syndrome and Knee, run by Istanbul Medeniyet 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 5 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: status not confirmed, as of the sponsor's last update on 24 Aug 2022. 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?
Results are not available in the source record.
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?
Knee pain (time frame: baseline). The study lists 9 primary outcomes in all. 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 24 Aug 2022.