Patellofemoral Pain SyndromeNCT05327569
The Efficacy of Myofascial Chain Release Techniques in Patients With Patellofemoral Pain Syndrome.
A study testing Myofascial Chain Release Techniques in people with Patellofemoral Pain Syndrome, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effects of myofascial release techniques applied on the superficial anterior myofascial chain of the body on pain, functional status, posture, biomechanical and viscoelastic properties of myofascial tissues in patients with patellofemoral pain syndrome. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Myofascial Chain Release Techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2022to 10 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
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 this study was to evaluate the effects of myofascial release techniques applied on the superficial anterior myofascial chain of the body on pain, functional status, posture, biomechanical and viscoelastic properties of myofascial tissues in patients with patellofemoral pain syndrome.
There will be two groups in this study. Each group will consist of 30 patients aged 25-50 years with patellofemoral pain syndrome. A total of 60 participants will take part in the study. Conventional physiotherapy will be applied to the control group, while myofascial release techniques will be applied to the experimental group in addition to conventional physiotherapy. Treatment programs will be applied to both groups 2 days a week for 6 weeks. 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 and pelvic tilt. In addition to all these assessments, knee pain, lower extremity functionality and biomechanical properties of the anterior myofascial tissue will be evaluated.
Read the detailed description
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 Patellofemoral pain syndrome. But it has been reported in recent studies that myofascial problems can be related with patellofemoral pain syndrom. It is stated that the fascial chain containing the Patellofemoral pain syndrome-related regions is the Superficial Anterior Chain, and this chain starts from the toe extensors and ends at the masteoid process. The aim of this study was to evaluate the effects of myofascial release techniques applied on the superficial anterior myofascial chain of the body on pain, functional status, posture, biomechanical and viscoelastic properties of myofascial tissues in patients with patellofemoral pain syndrome.
There will be two groups in this study. Each group will consist of 30 patients aged 25-50 years with patellofemoral pain syndrome. A total of 60 participants will take part in the study. Conventional physiotherapy will be applied to the control group, while myofascial release techniques will be applied to the experimental group in addition to conventional physiotherapy. Treatment programs will be applied to both groups 2 days a week for 6 weeks. 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 and pelvic tilt. In addition to all these assessments, knee pain, lower extremity functionality and biomechanical properties of the anterior myofascial tissue will be evaluated.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Myofascial Chain Release Techniques
- Keywords
- Patellofemoral Pain Syndrome, Fascia, Myofascial Release Therapy
- 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.
Myofascial Chain Release TechniquesOther
Myofascial release technique will be applied to the center of coordination points in the anterior superficial myofascial chain of the body. There are a total of 8 points on this myofascial chain. Pressure will be applied to each point with 6 repetitions and lasting approximately 5-6 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | xperimental group will consist of 30 patients with diagnosed Patellofemoral pain syndrome, aged between 25-50 years. In addition to the conventional physiotherapy program, myofascial chain release techniques will be applied to this group.
Myofascial release technique will be applied to the center of coordination points in the anterior superficial myofascial chain of the body. There are a total of 8 points on this myofascial chain. Pressure will be applied to each point with 6 repetitions and lasting approximately 5-6 seconds.
Participants will be treated for a total of 6 weeks, 2 days a week. Each treatment session will last 45 minutes. Receives: Other: Myofascial Chain Release Techniques |
| Control group | No intervention | Control group will consist of 30 patients with diagnosed Patellofemoral pain syndrome, aged between 25-50 years. Only conventional physiotherapy program will be applied to this group. Conventional treatment will consist of muscle strengthening, stretching exercises and patellar mobilization. The muscle groups to be strengthened are: M. gluteus maximus, M. gluteus medius, M. Quadriceps, Core group of muscles. The muscle groups and tendons to be stretched are: M. Hamstrings, achilles tendon and iliotibial band. The exercises will be performed as 10 repetitions and 3 sets. Participants will be treated for a total of 6 weeks, 2 days a week. Each treatment session will last 45 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain
Visual Analogue Scale will be used in the assessment of pain severity. It expresses pain severity between a score of 0 (no pain) and 10 (unbearably severe pain).
Measured: Change from baseline knee pain at week 6.
Forward head
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 participants 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. Forward head posture is characterized as pathologic when the craniovertebral angle (CVA) is ≥50°.
Measured: Change from baseline craniovertebral angle at week 6.
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.
Measured: Change from baseline Q-angle at week 6.
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: Change from baseline genu varum at week 6.
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: Change from baseline genu valgum at week 6.
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: Change from baseline pes planus at week 6.
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: Change from baseline foot posture at week 6.
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: Change from baseline pelvic tilt at week 6.
Lower extremity functionality
Lower extremity functional scale will be used. This scale is a valid and reliable scale used in musculoskeletal problems affecting the lower extremities. It consists of 20 items. Each item is scored between 0-4. The total score is between 0-80. Higher scores indicate better functional status.
Measured: Change from baseline lower extremity functionality at week 6.
elacticity
Elacticity 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). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.
Measured: Change from baseline Biomechanical and viscoelastic properties of myofascial tissues at week 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start20 Sep 2022 (estimated)
- Primary completion2 May 2023 (estimated)
- Study completion10 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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two groups in this study. Each group will consist of 30 patients aged 25-50 years with patellofemoral pain syndrome. A total of 60 participants will take part in the study. Conventional physiotherapy will be applied to the control group, while myofascial release techniques will be applied to the experimental group in addition to conventional physiotherapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 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
- NCT05327569
- Sponsor's protocol ID
- 2022/0076
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 26 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 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Myofascial Chain Release Techniques in Patients With Patellofemoral Pain Syndrome.
- ClinicalTrials.gov ID
- NCT05327569
- Acronym / sponsor ID
- 2022/0076
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Patellofemoral Pain Syndrome, Fascia, Myofascial Release Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 20 Sep 2022 (estimated)
- Primary completion
- 2 May 2023 (estimated)
- Study completion
- 10 Jun 2023 (estimated)
- First posted
- 14 Apr 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 this study was to evaluate the effects of myofascial release techniques applied on the superficial anterior myofascial chain of the body on pain, functional status, posture, biomechanical and viscoelastic properties of myofascial tissues in patients with patellofemoral pain syndrome.
There will be two groups in this study. Each group will consist of 30 patients aged 25-50 years with patellofemoral pain syndrome. A total of 60 participants will take part in the study. Conventional physiotherapy will be applied to the control group, while myofascial release techniques will be applied to the experimental group in addition to conventional physiotherapy. Treatment programs will be applied to both groups 2 days a week for 6 weeks. 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 and pelvic tilt. In addition to all these assessments, knee pain, lower extremity functionality and biomechanical properties of the anterior myofascial tissue will be evaluated.
Detailed description
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 Patellofemoral pain syndrome. But it has been reported in recent studies that myofascial problems can be related with patellofemoral pain syndrom. It is stated that the fascial chain containing the Patellofemoral pain syndrome-related regions is the Superficial Anterior Chain, and this chain starts from the toe extensors and ends at the masteoid process. The aim of this study was to evaluate the effects of myofascial release techniques applied on the superficial anterior myofascial chain of the body on pain, functional status, posture, biomechanical and viscoelastic properties of myofascial tissues in patients with patellofemoral pain syndrome.
There will be two groups in this study. Each group will consist of 30 patients aged 25-50 years with patellofemoral pain syndrome. A total of 60 participants will take part in the study. Conventional physiotherapy will be applied to the control group, while myofascial release techniques will be applied to the experimental group in addition to conventional physiotherapy. Treatment programs will be applied to both groups 2 days a week for 6 weeks. 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 and pelvic tilt. In addition to all these assessments, knee pain, lower extremity functionality and biomechanical properties of the anterior myofascial tissue will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There will be two groups in this study. Each group will consist of 30 patients aged 25-50 years with patellofemoral pain syndrome. A total of 60 participants will take part in the study. Conventional physiotherapy will be applied to the control group, while myofascial release techniques will be applied to the experimental group in addition to conventional physiotherapy
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Myofascial Chain Release Techniquesxperimental group will consist of 30 patients with diagnosed Patellofemoral pain syndrome, aged between 25-50 years. In addition to the conventional physiotherapy program, myofascial chain release techniques will be applied to this group. Myofascial release technique will be applied to the center of coordination points in the anterior superficial myofascial chain of the body. There are a total of 8 points on this myofascial chain. Pressure will be applied to each point with 6 repetitions and lasting approximately 5-6 seconds. Participants will be treated for a total of 6 weeks, 2 days a week. Each treatment session will last 45 minutes. |
| Control group | No intervention | –Control group will consist of 30 patients with diagnosed Patellofemoral pain syndrome, aged between 25-50 years. Only conventional physiotherapy program will be applied to this group. Conventional treatment will consist of muscle strengthening, stretching exercises and patellar mobilization. The muscle groups to be strengthened are: M. gluteus maximus, M. gluteus medius, M. Quadriceps, Core group of muscles. The muscle groups and tendons to be stretched are: M. Hamstrings, achilles tendon and iliotibial band. The exercises will be performed as 10 repetitions and 3 sets. Participants will be treated for a total of 6 weeks, 2 days a week. Each treatment session will last 45 minutes. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Myofascial Chain Release TechniquesMyofascial release technique will be applied to the center of coordination points in the anterior superficial myofascial chain of the body. There are a total of 8 points on this myofascial chain. Pressure will be applied to each point with 6 repetitions and lasting approximately 5-6 seconds. | Other | Experimental group |
Primary outcome
Knee pain
Time frame: Change from baseline knee pain at week 6.
Visual Analogue Scale will be used in the assessment of pain severity. It expresses pain severity between a score of 0 (no pain) and 10 (unbearably severe pain).
Forward head
Time frame: Change from baseline craniovertebral angle at week 6.
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 participants 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. Forward head posture is characterized as pathologic when the craniovertebral angle (CVA) is ≥50°.
Q-Angle
Time frame: Change from baseline Q-angle at week 6.
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.
Genu varum
Time frame: Change from baseline genu varum at week 6.
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: Change from baseline genu valgum at week 6.
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: Change from baseline pes planus at week 6.
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: Change from baseline foot posture at week 6.
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: Change from baseline pelvic tilt at week 6.
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.
Lower extremity functionality
Time frame: Change from baseline lower extremity functionality at week 6.
Lower extremity functional scale will be used. This scale is a valid and reliable scale used in musculoskeletal problems affecting the lower extremities. It consists of 20 items. Each item is scored between 0-4. The total score is between 0-80. Higher scores indicate better functional status.
elacticity
Time frame: Change from baseline Biomechanical and viscoelastic properties of myofascial tissues at week 6.
Elacticity 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). 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 26 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?
A study testing Myofascial Chain Release Techniques in people with Patellofemoral Pain Syndrome, 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 26 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: Change from baseline knee pain at week 6.). The study lists 10 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 26 Aug 2022.