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

Primary Purpose

Patellofemoral Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
kujala patellofemoral pain scale
Surface EMG
Q angle measurement
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Patellofemoral Pain focused on measuring onset , hamstring muscles, patellofemoral pain

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patellofemoral pain group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

kujala patellofemoral pain scale
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).
Numeric Rating Scale (NRS)
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.
Q angle
Q angle measurement in standing

Full Information

First Posted
December 20, 2017
Last Updated
January 5, 2018
Sponsor
Bahçeşehir University
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1. Study Identification

Unique Protocol Identification Number
NCT03392688
Brief Title
Time Difference Between Onsets of Lateral And Medial Hamstring Muscles During Gait in Patients With Patellofemoral Pain.
Official Title
Is There a Time Difference Between Onsets of Lateral and Medial Hamstring Muscles During Gait in Patients With Patellofemoral Pain Comparing to Healthy Subjects?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 21, 2014 (Actual)
Primary Completion Date
May 30, 2015 (Actual)
Study Completion Date
July 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain
Keywords
onset , hamstring muscles, patellofemoral pain

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patellofemoral pain group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
kujala patellofemoral pain scale
Intervention Description
Kujala patellofemoral pain scale was used to evaluate knee functions of the PFP subjects.
Intervention Type
Diagnostic Test
Intervention Name(s)
Surface EMG
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Q angle measurement
Intervention Description
Q angle measurement was applied to both patellofemoral pain and control group subjects in standing position.
Primary Outcome Measure Information:
Title
Time difference between the onsets of the medial and lateral hamstring muscles
Description
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
Time Frame
Preparing participants that include skin preparation and electrodes placement, and recording EMG data took average one hour for each participant
Secondary Outcome Measure Information:
Title
kujala patellofemoral pain scale
Description
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).
Time Frame
At the begining of the study each participant was asked to complete the scale. It took average 10 minutes. Performed once.
Title
Numeric Rating Scale (NRS)
Description
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.
Time Frame
Performed 1 day once.
Title
Q angle
Description
Q angle measurement in standing
Time Frame
Performed 1 day once.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilber Karagozoglu Coskunsu, Ass. Prof.
Organizational Affiliation
Bahcesehir University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Filiz Can, Prof.
Organizational Affiliation
Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Necla Ozturk, Prof.
Organizational Affiliation
Maltepe University, Faculty of Medicine, Deparment of Biophysics
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
N. Ekin Akalın, Prof.
Organizational Affiliation
Kultur University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul University,Faculty of Medicine, Deparment of Orthopedics and Traumatology, Gait Analysis Laboratory
City
Istanbul
State/Province
Europe
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
starting 6 months after publication
Citations:
PubMed Identifier
20724165
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
21295240
Citation
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.
Results Reference
background
PubMed Identifier
15183437
Citation
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.
Results Reference
background

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

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