Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05303610
Other study ID # 2022/0077
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 20, 2022
Est. completion date June 3, 2023

Study information

Verified date March 2022
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 56
Est. completion date June 3, 2023
Est. primary completion date May 5, 2023
Accepts healthy volunteers
Gender All
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

Other:
Observational
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.

Locations

Country Name City State
Turkey Emel Mete Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline
Primary 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°. baseline
Primary 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
baseline
Primary 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. baseline
Primary 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. baseline
Primary 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. baseline
Primary 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. baseline
Primary 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. baseline
Primary 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 baseline
See also
  Status Clinical Trial Phase
Withdrawn NCT04976972 - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation N/A
Completed NCT04564053 - Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants Phase 1
Not yet recruiting NCT03726788 - Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis Phase 2
Terminated NCT02713906 - Materialise X-ray Knee Guides for Total Knee Arthroplasty N/A
Recruiting NCT05613439 - The Fast-track Centre for Hip and Knee Replacement Database
Completed NCT04612036 - In Vivo Kinematics for Subjects With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA
Active, not recruiting NCT02578446 - Uncemented Tritanium Compared With Cemented Metal-backed Tibia Components in Total Knee Replacement N/A
Completed NCT04024592 - Reliability and Validity of Strength Measurement of the Lower Limbs in Typically Developing Children N/A
Completed NCT03450681 - Effectiveness of Pulsed Radiofrequency of the Saphenous Nerve in the Management of Knee Arthroplasty Pain N/A
Active, not recruiting NCT06404801 - Development of Stance Control Orthotic Knee Joint For Improvement of KAFO Users
Completed NCT00652808 - Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the Knee Phase 3
Suspended NCT03738384 - Knee Connect: Physiotherapy Exercise Performance With Visual Feedback After Total Knee Arthroplasty N/A
Recruiting NCT04818840 - Evaluate the Performance of JOURNEY II CR in TKA Populations
Recruiting NCT04728542 - A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study
Completed NCT04496440 - An Attempt to Find Out Root Cause of a Pain Producing Knee Disease
Active, not recruiting NCT06032507 - Effect of High-pressure Pulsatile Lavage Versus Manual Rinsing on Bone Cement Penetration in Total Knee Arthroplasty N/A
Withdrawn NCT00708474 - OsseoFit™ Prospective Data Collection N/A
Withdrawn NCT05895656 - Exploration of Knee Injuries Using 3 Tesla and 7 Tesla Magnetic Resonance Imaging at the University Hospital of Poitiers N/A
Completed NCT01821599 - Comparative Study Between Two Physiotherapy Protocols Conventional X Accelerated in Individuals Undergoing Reconstruction of the Anterior Cruciate Ligament. N/A
Completed NCT01169389 - Analgesic Control Following Knee Arthroscopy N/A