Time Difference Between Onsets of Lateral And Medial Hamstring Muscles During Gait in Patients With Patellofemoral Pain.

January 5, 2018 updated by: Dilber Karagozoglu Coskunsu, Bahçeşehir University

Is There a Time Difference Between Onsets of Lateral and Medial Hamstring Muscles During Gait in Patients With Patellofemoral Pain Comparing to Healthy Subjects?

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.

Study Overview

Detailed Description

Patellofemoral pain (PFP) is a very common complaint in younger population with still unclear and controversial etiology. It was suggested that a combination of intrinsic and extrinsic factors cause PFP. The strain of the retropatellar subcondral bone caused by excessive lateral patellar tracking is known to be the one among intrinsic factors (Thomee R.1999). Imbalance of the dynamics between knee extensor muscles, Vastus Medialis (VM) and Vastus Lateralis (VL), has also received a great research interest during last 10 years. However, uneven timing between onsets of counterpart knee flexor muscles, Lateral and Medial hamstring, were just considered as a possible etiological factor of the PFP (Patil S.2011), yet this hypothesis remains to be proven. The investigators aimed to investigate whether there is a relative time delays of the LH (biceps femoris, BF) and MH (semitendinosus, ST) during the walking at the self-selected speed in patients with patellofemoral pain. Even though dynamic EMG investigations are challenging because of cross-talks between muscles, hence difficult to determine clearly onset times, the investigators think that any information acquired during walking would be highly important because patellofemoral pain is mainly exaggerated by dynamic activities.

15 patients who were diagnosed with PFP (age 28.73±7.44, height 169.73±7.09, weight 67.47±14.31) and 15 asymptomatic subjects (age 30.47±6.22, height 167.87±7.81, weight 67.87±13.48) were recruited in the study. The inclusion criteria for PFP subjects was presence of the anterior and retropatellar pain for minimum 2 months scaled as 3 in accordance with Numeric Analog Scale during at least two of the following activities: stair descending, ascending, squatting, prolonged sitting, jumping, sitting on the knees. Surface EMG was recorded from Medial Hamstring and Lateral Hamstring muscles at 1000 Hz sampling rate during walking at participants' normal walking speed. EMG data obtained from 5 gait trials were evaluated. The EMG traces were full wave rectified and low pass filtered at 50 Hz. Delay in timing before heel strikes between MH and LH was calculated. Statistical significance between differences in time delays was analysed using "paired sample t-test".

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Europe
      • Istanbul, Europe, Turkey, 34093
        • Istanbul University,Faculty of Medicine, Deparment of Orthopedics and Traumatology, Gait Analysis Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criterias:

  • 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

Exclusion Criterias:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patellofemoral pain group

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.

Kujala patellofemoral pain scale was used to evaluate knee functions of the PFP subjects.
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.
Q angle measurement was applied to both patellofemoral pain and control group subjects in standing position.
ACTIVE_COMPARATOR: Control Group

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time difference between the onsets of the medial and lateral hamstring muscles
Time Frame: Preparing participants that include skin preparation and electrodes placement, and recording EMG data took average one hour for each participant
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
kujala patellofemoral pain scale
Time Frame: At the begining of the study each participant was asked to complete the scale. It took average 10 minutes. Performed once.
Kujala patellofemoral pain scale (Kujala 1993) is composed of 13 items that evaluate subjective symptoms and functional limitations. Minimum score is 0 points and maximum score is 100 points; higher values represent a worse outcome. Kujala patellofemoral pain scale is reported to be responsive, valid and demonstrates high test-retest reliability (Crosley K.2014). Turkish version of the Kujala patellofemoral pain score was used in our study (Kuru T. 2010).
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)
Time Frame: Performed 1 day once.
The NRS is an 11-point scale consisting of integers from 0 through 10; 0 representing ''No pain'' and 10 representing ''Worst imaginable pain.'' Participants select the single number that best represents their pain intensity.
Performed 1 day once.
Q angle
Time Frame: Performed 1 day once.
Q angle measurement in standing
Performed 1 day once.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dilber Karagozoglu Coskunsu, Ass. Prof., Bahçeşehir University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
  • Study Director: Filiz Can, Prof., Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 21, 2014

Primary Completion (ACTUAL)

May 30, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

January 5, 2018

First Posted (ACTUAL)

January 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 8, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • BahcesehirU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Patellofemoral Pain

Clinical Trials on kujala patellofemoral pain scale

Subscribe