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

NCT ID: NCT03392688

Last Updated: 2018-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-21

Study Completion Date

2015-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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".

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patellofemoral Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

kujala patellofemoral pain scale

Intervention Type OTHER

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

Surface EMG

Intervention Type DIAGNOSTIC_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.

Q angle measurement

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Surface EMG

Intervention Type DIAGNOSTIC_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.

Q angle measurement

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

kujala patellofemoral pain scale

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

Intervention Type OTHER

Surface EMG

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 DIAGNOSTIC_TEST

Q angle measurement

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 Criteria

* Previous history of knee surgery,
* History of patellar instability,
* Neurologic involvement that would influence gait
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bahçeşehir University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dilber Karagozoglu Coskunsu

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dilber Karagozoglu Coskunsu, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Filiz Can, Prof.

Role: STUDY_DIRECTOR

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

Necla Ozturk, Prof.

Role: STUDY_CHAIR

Maltepe University, Faculty of Medicine, Deparment of Biophysics

N. Ekin Akalın, Prof.

Role: STUDY_CHAIR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Istanbul, Europe, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20724165 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 21295240 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15183437 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BahcesehirU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.