Patello Femoral SyndromeNCT04624542
Relation Between Femoral Nerve Conduction Velocity and Its Mechanosensitivity Changes Among Patellofemoral Pain Syndrome
An observational study of Patello Femoral Syndrome, run by Cairo University.
Trial summary
1. to investigate the relation between NCV of femoral nerve and other dependent variables such as ( pain \& limited hip extension ROM )in patients with PFPS . 2. to predict using the NCV as a method for assessment femoral nerve mechanosensitivity in those with PFPS Read more about this study
- Who is it for?
- Ages 18 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Patello Femoral Syndrome
- What is being tested?
- Electromyographic device
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Aug 2021
- How long will I take part?
- 1 Month
- 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 36 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants recruitment to this study will be conducted over 2 steps process. In the first step, all participants in the experimental group that will be referred from an orthopedic surgeon with diagnosis of unilateral PFPS to the outpatient clinic at Cairo University hospital at kasr el ainy
Who may be able to join
- The inclusion criteria screened by the clinicians was pain during patellar palpation. In addition, subjects needed to fulfill all of the following requirements to be included in the PFP group:
- Patient reporting symptoms of insidious onset and duration of at least 1 month (de Oliveira et al .,2016)
- Peri- or retropatellar pain during at least 2 of the following activities: squatting, prolonged sitting, kneeling, running, jumping and climbing stairs (Vegstein et al., 2019)
- Worst pain level in the previous month of up to 3cm on a 10cm numerical rating scale (NRS). (de Oliveira et al .,2016)
- BMI 25-30 kg/cm2 (Nouri F et al .,2019)
- Showing 2 or more positive signs on the following clinical tests:
- Clarke's sign, Waldron test, active patellar grind test, patellar compression test ,and palpation of the medial/lateral articular border of the patella.(hung et al., 2015) To be included in the control group CG, participants could not present any signs or symptoms of PFP or other musculoskeletal conditions
Who cannot join
- 1) inflammatory process of lower limb (Lin et al., 2014 ) 2) patellar tendon or meniscus tears (hung et al., 2015) 3) bursitis and ligament tears (hung et al., 2015) 4) Those who had undergone knee surgery, oral steroids and knee injection were excluded from this study (Vegstein et al., 2019) 5) lower back dysfunction such as disc lesion , sciatica or spondylolisthesis (Lin et al., 2014 ) 6) participants that had undergone physiotherapy during the preceding 6 months (de Oliveira et al .,2016)
Trial locations and contacts
No sites are listed yet.
nabil ab abdo, PHD contact
About this study
Official title: Relation Between Femoral Nerve Conduction Velocity and Its Mechanosensitivity Changes Among Individual With Patellofemoral Pain Syndrome
- to investigate the relation between NCV of femoral nerve and other dependent variables such as ( pain \& limited hip extension ROM )in patients with PFPS .
- to predict using the NCV as a method for assessment femoral nerve mechanosensitivity in those with PFPS
Read the detailed description
Patellofemoral pain syndrome (PFPS) is considered one of the most common condition affecting young active populations, it accounts for about 40% of individuals complaining from knee pain.PFPS is the anterior or retro patellar pain that can be precipitated by some daily activities such as ascending and descending stairs, kneeling, squatting or performing everyday tasks. Individuals with PFPS can experience a history of cracking or popping sounds when changing position or climbing stairs and also experience pain during repeated knee flexion. In a previous study conducted by Jensen et al .(2008),they observed that individuals with PFPS experienced symptoms that are related to neural compromise like patellar numbness and reduced ability to differentiate between different thermal stimulus .so PFPS may be related to neurological impairments or dysfunction.
Femoral slump test can be used in examining the neurodynamic responses in individuals with anterior knee pain which has a specificity of more than 75% in testing neural mechanosensitivity In a study conducted by Lin et al (2014) that examine the hip extension range of motion (ROM) and mechanical sensitivity of femoral nerve as a neurodynamic response in individuals with PFPS , they proposed that 30% of them have decrease hip extension ROM and increased mechanosensitivity comparison with healthy individuals. The current management of the patellofemoral pain support using open- and closed-chain exercises, strengthening, stretching, aerobic exercise, patellofemoral and tibiofemoral mobilizations, patellar taping, highintensity NMES, neuromuscular training, and gait retraining as a multi modal treatment for PFPS. Despite these methods result in significant improvement, other few patients reported some residual symptoms Hung et al .,(2015) have encouraged that using the femoral nerve mobilization as a neurodynamic management for treating PFPS patients especially those with postive femoral slump test , and testing the hip extension range of motion as a reference of improvement previous studies reported the presence of neurogenic dysfunction model to PFPS but most of these scientific researches lack the presence of the gold standard and objective method for identifying the neurogenic patellofemoral pain
- Conditions
- Patello Femoral Syndrome
- Being tested
- Electromyographic device
- Keywords
- femoral nerve conduction velocity
- 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.
Electromyographic deviceDevice
the EMG machine will be used to measure NCV of femoral nerve within individuals with PFPS
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Thirty individuals diagnosed with unilateral chronic PFPS from both genders and age between 18-35 years who will be referred from an orthopedic surgeon. Receives: Device: Electromyographic device | |
| control group | -30 healthy active individuals ranging from 18-36 yrs as a controlled group Receives: Device: Electromyographic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
the patellofemoral pain
pain will be measured by using the Pain numeric rating scale (NRS)
Measured: 6 months
Secondary outcomes (1)
range of hip extension
ROM will be measured using universal goniometer
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Patello Femoral SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Abdo Abdellah Mohamed, Cairo University
- Investigators
- nabil ab abdo, Study director, PHD faculty of physical therapy Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624542
- Sponsor's protocol ID
- NCV for PFPS
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the data include his /her name ,age, sex , demographic data including (height,weight \&BMI ) and the phone number and address with ID number
Publications
Fredericson M, Yoon K. Physical examination and patellofemoral pain syndrome. Am J Phys Med Rehabil. 2006 Mar;85(3):234-43. doi: 10.1097/01.phm.0000200390.67408.f0.
PubMed 16505640Fredericson M, Powers CM. Practical management of patellofemoral pain. Clin J Sport Med. 2002 Jan;12(1):36-8. doi: 10.1097/00042752-200201000-00010. No abstract available.
PubMed 11854587Jensen R, Kvale A, Baerheim A. Is pain in patellofemoral pain syndrome neuropathic? Clin J Pain. 2008 Jun;24(5):384-94. doi: 10.1097/AJP.0b013e3181658170.
PubMed 18496302Jensen R, Hystad T, Kvale A, Baerheim A. Quantitative sensory testing of patients with long lasting Patellofemoral pain syndrome. Eur J Pain. 2007 Aug;11(6):665-76. doi: 10.1016/j.ejpain.2006.10.007. Epub 2007 Jan 3.
PubMed 17204440Eliav E, Benoliel R, Tal M. Inflammation with no axonal damage of the rat saphenous nerve trunk induces ectopic discharge and mechanosensitivity in myelinated axons. Neurosci Lett. 2001 Sep 21;311(1):49-52. doi: 10.1016/s0304-3940(01)02143-7.
PubMed 11585565Sanchis-Alfonso V, Rosello-Sastre E. Immunohistochemical analysis for neural markers of the lateral retinaculum in patients with isolated symptomatic patellofemoral malalignment. A neuroanatomic basis for anterior knee pain in the active young patient. Am J Sports Med. 2000 Sep-Oct;28(5):725-31. doi: 10.1177/03635465000280051801.
PubMed 11032232Heintjes E, Berger MY, Bierma-Zeinstra SM, Bernsen RM, Verhaar JA, Koes BW. Exercise therapy for patellofemoral pain syndrome. Cochrane Database Syst Rev. 2003;(4):CD003472. doi: 10.1002/14651858.CD003472.
PubMed 14583980Smith BE, Selfe J, Thacker D, Hendrick P, Bateman M, Moffatt F, Rathleff MS, Smith TO, Logan P. Incidence and prevalence of patellofemoral pain: A systematic review and meta-analysis. PLoS One. 2018 Jan 11;13(1):e0190892. doi: 10.1371/journal.pone.0190892. eCollection 2018.
PubMed 29324820
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Femoral Nerve Conduction Velocity and Its Mechanosensitivity Changes Among Individual With Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT04624542
- Acronym / sponsor ID
- NCV for PFPS
- Conditions
- Patello Femoral Syndrome
- Keywords
- femoral nerve conduction velocity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 12 Nov 2020 (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.
- to investigate the relation between NCV of femoral nerve and other dependent variables such as ( pain \& limited hip extension ROM )in patients with PFPS .
- to predict using the NCV as a method for assessment femoral nerve mechanosensitivity in those with PFPS
Detailed description
Patellofemoral pain syndrome (PFPS) is considered one of the most common condition affecting young active populations, it accounts for about 40% of individuals complaining from knee pain.PFPS is the anterior or retro patellar pain that can be precipitated by some daily activities such as ascending and descending stairs, kneeling, squatting or performing everyday tasks. Individuals with PFPS can experience a history of cracking or popping sounds when changing position or climbing stairs and also experience pain during repeated knee flexion. In a previous study conducted by Jensen et al .(2008),they observed that individuals with PFPS experienced symptoms that are related to neural compromise like patellar numbness and reduced ability to differentiate between different thermal stimulus .so PFPS may be related to neurological impairments or dysfunction.
Femoral slump test can be used in examining the neurodynamic responses in individuals with anterior knee pain which has a specificity of more than 75% in testing neural mechanosensitivity In a study conducted by Lin et al (2014) that examine the hip extension range of motion (ROM) and mechanical sensitivity of femoral nerve as a neurodynamic response in individuals with PFPS , they proposed that 30% of them have decrease hip extension ROM and increased mechanosensitivity comparison with healthy individuals. The current management of the patellofemoral pain support using open- and closed-chain exercises, strengthening, stretching, aerobic exercise, patellofemoral and tibiofemoral mobilizations, patellar taping, highintensity NMES, neuromuscular training, and gait retraining as a multi modal treatment for PFPS. Despite these methods result in significant improvement, other few patients reported some residual symptoms Hung et al .,(2015) have encouraged that using the femoral nerve mobilization as a neurodynamic management for treating PFPS patients especially those with postive femoral slump test , and testing the hip extension range of motion as a reference of improvement previous studies reported the presence of neurogenic dysfunction model to PFPS but most of these scientific researches lack the presence of the gold standard and objective method for identifying the neurogenic patellofemoral pain
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Device: Electromyographic deviceThirty individuals diagnosed with unilateral chronic PFPS from both genders and age between 18-35 years who will be referred from an orthopedic surgeon. |
| control group | – | Device: Electromyographic device-30 healthy active individuals ranging from 18-36 yrs as a controlled group |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants recruitment to this study will be conducted over 2 steps process. In the first step, all participants in the experimental group that will be referred from an orthopedic surgeon with diagnosis of unilateral PFPS to the outpatient clinic at Cairo University hospital at kasr el ainy
Key inclusion criteria (7 listed)
- The inclusion criteria screened by the clinicians was pain during patellar palpation. In addition, subjects needed to fulfill all of the following requirements to be included in the PFP group:
- Clarke's sign, Waldron test, active patellar grind test, patellar compression test ,and palpation of the medial/lateral articular border of the patella.(hung et al., 2015) To be included in the control group CG, participants could not present any signs or symptoms of PFP or other musculoskeletal conditions
Key exclusion criteria (1 listed)
- 1) inflammatory process of lower limb (Lin et al., 2014 ) 2) patellar tendon or meniscus tears (hung et al., 2015) 3) bursitis and ligament tears (hung et al., 2015) 4) Those who had undergone knee surgery, oral steroids and knee injection were excluded from this study (Vegstein et al., 2019) 5) lower back dysfunction such as disc lesion , sciatica or spondylolisthesis (Lin et al., 2014 ) 6) participants that had undergone physiotherapy during the preceding 6 months (de Oliveira et al .,2016)
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 |
|---|---|---|
| Electromyographic devicethe EMG machine will be used to measure NCV of femoral nerve within individuals with PFPS | Device | control group, group 1 |
Primary outcome
the patellofemoral pain
Time frame: 6 months
pain will be measured by using the Pain numeric rating scale (NRS)
1 secondary outcome
range of hip extension
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Background: PubMed 16505640Fredericson M, Yoon K. Physical examination and patellofemoral pain syndrome. Am J Phys Med Rehabil. 2006 Mar;85(3):234-43. doi: 10.1097/01.phm.0000200390.67408.f0.
- Background: PubMed 11854587Fredericson M, Powers CM. Practical management of patellofemoral pain. Clin J Sport Med. 2002 Jan;12(1):36-8. doi: 10.1097/00042752-200201000-00010. No abstract available.
- Background: PubMed 18496302Jensen R, Kvale A, Baerheim A. Is pain in patellofemoral pain syndrome neuropathic? Clin J Pain. 2008 Jun;24(5):384-94. doi: 10.1097/AJP.0b013e3181658170.
- Background: PubMed 17204440Jensen R, Hystad T, Kvale A, Baerheim A. Quantitative sensory testing of patients with long lasting Patellofemoral pain syndrome. Eur J Pain. 2007 Aug;11(6):665-76. doi: 10.1016/j.ejpain.2006.10.007. Epub 2007 Jan 3.
- Background: PubMed 11585565Eliav E, Benoliel R, Tal M. Inflammation with no axonal damage of the rat saphenous nerve trunk induces ectopic discharge and mechanosensitivity in myelinated axons. Neurosci Lett. 2001 Sep 21;311(1):49-52. doi: 10.1016/s0304-3940(01)02143-7.
- Background: PubMed 11032232Sanchis-Alfonso V, Rosello-Sastre E. Immunohistochemical analysis for neural markers of the lateral retinaculum in patients with isolated symptomatic patellofemoral malalignment. A neuroanatomic basis for anterior knee pain in the active young patient. Am J Sports Med. 2000 Sep-Oct;28(5):725-31. doi: 10.1177/03635465000280051801.
- Background: PubMed 14583980Heintjes E, Berger MY, Bierma-Zeinstra SM, Bernsen RM, Verhaar JA, Koes BW. Exercise therapy for patellofemoral pain syndrome. Cochrane Database Syst Rev. 2003;(4):CD003472. doi: 10.1002/14651858.CD003472.
- Results publication: PubMed 29324820Smith BE, Selfe J, Thacker D, Hendrick P, Bateman M, Moffatt F, Rathleff MS, Smith TO, Logan P. Incidence and prevalence of patellofemoral pain: A systematic review and meta-analysis. PLoS One. 2018 Jan 11;13(1):e0190892. doi: 10.1371/journal.pone.0190892. eCollection 2018.
- Individual participant dataSharing planned: Undecided. the data include his /her name ,age, sex , demographic data including (height,weight \&BMI ) and the phone number and address with ID number
Related trials for Patello Femoral Syndrome
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)
RecruitingObservational study
Assessing the Association Between WBCT PFJ Morphological Metrics and Knee Symptoms
Knee Osteoarthritis, Patellofemoral Pain (PFPS)
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.
nabil ab abdo, PHD contact
nabil ab abdo study director
PHD faculty of physical therapy Cairo university
Questions about this trial
What is this clinical trial studying?
An observational study of Patello Femoral Syndrome, run by Cairo University.
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 7 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: status not confirmed, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact ramez fd fahim, Bachelor (201211553069, ramezfahim1993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the patellofemoral pain (time frame: 6 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 NCT04624542, which also lists 8 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 12 Nov 2020.