- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03392688
Time Difference Between Onsets of Lateral And Medial Hamstring Muscles During Gait in Patients With Patellofemoral Pain.
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Europe
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Istanbul, Europe, Turkey, 34093
- Istanbul University,Faculty of Medicine, Deparment of Orthopedics and Traumatology, Gait Analysis Laboratory
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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 |
|---|---|---|
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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.
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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).
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At the begining of the study each participant was asked to complete the scale. It took average 10 minutes. Performed once.
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Numeric Rating Scale (NRS)
Time Frame: Performed 1 day once.
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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.
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Performed 1 day once.
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Q angle
Time Frame: Performed 1 day once.
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Q angle measurement in standing
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Performed 1 day once.
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Collaborators and Investigators
Sponsor
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
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BahcesehirU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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