NCT05303610

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2023

Completed
Last Updated

August 24, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

March 22, 2022

Last Update Submit

August 23, 2022

Conditions

Keywords

Patellofemoral Syndromekneeconnective tissuefascia

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Experimental group

This group will consist of 28 patients with diagnosed Patellofemoral pain syndrome, aged between 25-50 years.

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.).

Other: Observational

Interventions

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.

Control groupExperimental group

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emel Mete

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

March 22, 2022

First Posted

March 31, 2022

Study Start

September 20, 2022

Primary Completion

May 5, 2023

Study Completion

June 3, 2023

Last Updated

August 24, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations