NCT03392688

Brief Summary

Early activation of lateral hamstrings (LH) in respect of medial hamstrings (MH) may cause abnormal knee abduction and external rotation moments in individuals. This situation may increase the risk of ligament injury and may be the reason for susceptibility of patellofemoral pain (PFP). The aim of this study is to compare the time delays in electromyographic studies between medial and lateral hamstrings in patients with PFP and asymptomatic subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 21, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

December 20, 2017

Last Update Submit

January 5, 2018

Conditions

Keywords

onset , hamstring muscles, patellofemoral pain

Outcome Measures

Primary Outcomes (1)

  • Time difference between the onsets of the medial and lateral hamstring muscles

    The surface EMG electrodes (silver/silver chloride, pre-gelled, Ambu Blue Sensor, Denmark) (Konrad P.) with an interelectrode distance of 20 mm between centers were used to record an EMG signal during walking. Portable 8 channel (TELEEMG, BTS, Milan, Italy) with built in x10 amplifications, 10-450 Hz bandpass and sampling rate of 1000 Hz were used for recording. The location and orientation of the electrodes for each MH (ST) and LH (BF) were identified according to SENIAM (Surface ElectromyoGraphy for the Non-Invasive Assessment of Muscles) criteria

    Preparing participants that include skin preparation and electrodes placement, and recording EMG data took average one hour for each participant

Secondary Outcomes (3)

  • kujala patellofemoral pain scale

    At the begining of the study each participant was asked to complete the scale. It took average 10 minutes. Performed once.

  • Numeric Rating Scale (NRS)

    Performed 1 day once.

  • Q angle

    Performed 1 day once.

Study Arms (2)

Patellofemoral pain group

EXPERIMENTAL

Diagnosis of PFP was established based on symptoms, physical examination performed by an orthopedic surgeon. Patients were also screened through physical examination to rule out ligamentous or meniscal injuries, patellar tendinitis and knee joint effusion by an orthopedic surgeon. All patients also underwent a radiologic examination consisting of AP, lateral and tangential radiograms. Surface EMG, Kujala patellofemoral pain scale, Q angle measurement were administered to the PFP group.

Other: kujala patellofemoral pain scaleDiagnostic Test: Surface EMGOther: Q angle measurement

Control Group

ACTIVE COMPARATOR

Control group had similar demographic characteristics with PFP group, and neither one of the controls had any knee pathology or current knee pain or effusion that would effect the gait. Surface EMG, Q angle measurement were administered to the control group.

Diagnostic Test: Surface EMGOther: Q angle measurement

Interventions

Kujala patellofemoral pain scale was used to evaluate knee functions of the PFP subjects.

Patellofemoral pain group
Surface EMGDIAGNOSTIC_TEST

The surface EMG electrodes (silver/silver chloride, pre-gelled, Ambu Blue Sensor, Denmark) (Konrad P.) with an interelectrode distance of 20 mm between centers were used to record an EMG signal during walking. Portable 8 channel (TELEEMG, BTS, Milan, Italy) with built in x10 amplifications, 10-450 Hz bandpass and sampling rate of 1000 Hz were used for recording. The location and orientation of the electrodes for each MH (ST) and LH (BF) were identified according to SENIAM (Surface ElectromyoGraphy for the Non-Invasive Assessment of Muscles) criteria.

Control GroupPatellofemoral pain group

Q angle measurement was applied to both patellofemoral pain and control group subjects in standing position.

Control GroupPatellofemoral pain group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pain originating specifically from the patellofemoral articulation (vague or localized);
  • At least 3/10 pain intensity accordingly to the Numeric Analog Scale (NAS) with at least 2 of the following functional activities commonly associated with PFP stair ascent or descent, squatting, kneeling, or prolonged sitting;
  • Reports of pain greater than 2 months in duration.
  • Being between 18-40 years of age

You may not qualify if:

  • Previous history of knee surgery,
  • History of patellar instability,
  • Neurologic involvement that would influence gait

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University,Faculty of Medicine, Deparment of Orthopedics and Traumatology, Gait Analysis Laboratory

Istanbul, Europe, 34093, Turkey (Türkiye)

Location

Related Publications (4)

  • Patil S, Dixon J, White LC, Jones AP, Hui AC. An electromyographic exploratory study comparing the difference in the onset of hamstring and quadriceps contraction in patients with anterior knee pain. Knee. 2011 Oct;18(5):329-32. doi: 10.1016/j.knee.2010.07.007. Epub 2010 Aug 17.

    PMID: 20724165BACKGROUND
  • Cowan S.M , Bennell K.L., Hodges P.W, Mc Connel J (2000). The test-retest reliability of the onset of concentric and eccentric vastus medialis obliquus and vastus lateralis electromyographic activity in a stair stepping task. Physical Therapy in Sport. 1, 129-136.

    BACKGROUND
  • Ng EC, Chui MP, Siu AY, Yam VW, Ng GY. Ankle positioning and knee perturbation affect temporal recruitment of the vasti muscles in people with patellofemoral pain. Physiotherapy. 2011 Mar;97(1):65-70. doi: 10.1016/j.physio.2010.05.009.

    PMID: 21295240BACKGROUND
  • Li G, DeFrate LE, Zayontz S, Park SE, Gill TJ. The effect of tibiofemoral joint kinematics on patellofemoral contact pressures under simulated muscle loads. J Orthop Res. 2004 Jul;22(4):801-6. doi: 10.1016/j.orthres.2003.11.011.

    PMID: 15183437BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

ElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Study Officials

  • Dilber Karagozoglu Coskunsu, Ass. Prof.

    Bahcesehir University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR
  • Filiz Can, Prof.

    Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

    STUDY DIRECTOR
  • Necla Ozturk, Prof.

    Maltepe University, Faculty of Medicine, Deparment of Biophysics

    STUDY CHAIR
  • N. Ekin Akalın, Prof.

    Kultur University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The algorithm used to calculate the onset of the EMG was identified according to the point at which the signal deviated by more than three times standard deviations, for a minimum of 25 ms from the baseline level (computing started 200 ms prior to the start of walking). MatLab program (R2011 version) was used for design a custom made program for data analysis. Additionally to automatic calculation, all data was visually checked to ensure that there was no signal noise, deteriorating the signal analysis, possibly caused by the movement artefact. A blind assessor visualy checked the onsets of the MH and LH muscles and record the onset time.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Participants which were included in the study were divided into 2 groups as patient group who included the patients diagnosed with Patellofemoral pain and asymptomatic group which was considered as control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 20, 2017

First Posted

January 8, 2018

Study Start

January 21, 2014

Primary Completion

May 30, 2015

Study Completion

July 1, 2015

Last Updated

January 8, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
starting 6 months after publication

Locations