NCT04624542

Brief Summary

  1. 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. 2.to predict using the NCV as a method for assessment femoral nerve mechanosensitivity in those with PFPS

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

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

November 5, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

November 5, 2020

Last Update Submit

November 5, 2020

Conditions

Keywords

femoral nerve conduction velocity

Outcome Measures

Primary Outcomes (1)

  • the patellofemoral pain

    pain will be measured by using the Pain numeric rating scale (NRS)

    6 months

Secondary Outcomes (1)

  • range of hip extension

    6 month

Study Arms (2)

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.

Device: Electromyographic device

control group

-30 healthy active individuals ranging from 18-36 yrs as a controlled group

Device: Electromyographic device

Interventions

the EMG machine will be used to measure NCV of femoral nerve within individuals with PFPS

control groupgroup 1

Eligibility Criteria

Age18 Years - 36 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • \) 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 16505640BACKGROUND
  • Fredericson 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.

    PMID: 11854587BACKGROUND
  • Jensen 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.

    PMID: 18496302BACKGROUND
  • Jensen 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.

    PMID: 17204440BACKGROUND
  • Eliav 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.

    PMID: 11585565BACKGROUND
  • Sanchis-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.

    PMID: 11032232BACKGROUND
  • Heintjes 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.

    PMID: 14583980BACKGROUND
  • Smith 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.

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • nabil ab abdo

    PHD faculty of physical therapy Cairo university

    STUDY DIRECTOR

Central Study Contacts

ramez fd fahim, Bachelor

CONTACT

nabil ab abdo, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of orthopedic physiotherapy /faculty of physical therapy cairo university

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 12, 2020

Study Start

December 1, 2020

Primary Completion

June 1, 2021

Study Completion

August 1, 2021

Last Updated

November 12, 2020

Record last verified: 2020-11