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Trial registered on ANZCTR


Registration number
ACTRN12610000115033
Ethics application status
Approved
Date submitted
28/01/2010
Date registered
3/02/2010
Date last updated
3/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gluteus medius electromyographic activation pattern during weight-bearing functional tasks in females with and without patellofemoral pain
Scientific title
Gluteus medius electromyographic activation pattern during weight-bearing functional tasks in females with and without patellofemoral pain
Secondary ID [1] 1357 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patellofemoral pain 256697 0
Condition category
Condition code
Musculoskeletal 256852 256852 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This research is a cross-sectional study comparing the gluteus medius (GM)electromiographic (EMG) activation pattern between females with and without patellofemoral pain.
GM EMG activation pattern. Subjects will be reported to the Musculoskeletal Laboratory for a single testing session. Prior to testing, subjects will perfome a 5-minute warm-up walking on a treadmill (Proaction BH Fitness Explorer) at a 1.66 m s -1 speed. Before the electrode placement, the skin will be shaved, abraded and cleaned with isopropyl alcohol. Bipolar silver/silver chloride (Ag/AgCl) surface electrodes (Meditrace TM 100, Mansfield, Canada, CA) will be placed one-half of the distance between the iliac crest and the greater trochanter, and also midway between the anterior and posterior superior iliac spines over the muscle belly of the GM. Surface electrodes, will be placed parallel to the GM muscle fibers. The reference electrode will be positioned on the radial styloid process.
EMG signals as well as the footswitch data will be obtained using an eight channel module (EMG System ), consisting of a signal conditioner with a band pass filter with cut-off frequencies at 20-500Hz, an amplifier gain of x1000 and a common mode rejection ratio >120dB. The data will undergo to an analog to digital conversion (12 bits) with a sampling frequency of anti-aliasing> 1000 Hz and an input range of 5mV. The raw EMG data will be stored on a personal computer for analysis with a custom program in Matlab (Mathworks, Natick, Massachusetts, USA).
The maximal voluntary isometric contraction (MIVC) for the GM to normalize the raw EMG data will be performed using the isokinetic dynamometer (Biodex Multi-Joint System 2, Biodex Medical Incorporation, New York, NY, USA). GM MIVC will be measured with the subject positioned in the side lying position. The dynamometer’s axis rotation will be aligned with a point on the subject representing the intersection of two straight lines. One line will be directed inferiorly from the posterior superior iliac spine toward the knee, and the other line will be directed from the greater trochanter of the femur toward the midline of the body. The lever arm of the dynamometer will be attached with straps five centimeters above the superior patella border. The hip will be placed in a position that is neutrally aligned in all three planes. The subjects will be instructed to keep their toes pointed forward and not to bend their knees. Subjects will complete two 5-second GM MVIC. Rest intervals of one minute will be given between trials. The EMG signal collected during the second trial will be used to normalize the signal collected during walking, descending stairs and single leg jumping.
To determine the foot contact with the floor during the functional activities, a footswitch (EMG System) will placed in each subject’s shoe of the lower extremity being tested. The footswitch will be placed under the rearfoot during the walking testing and under the forefoot during the descending stairs and single leg jumping tests.
The familiarization procedures and the evaluations will be conducted in a random order amongst the subjects. The subjects will performe a minimum of 1 minute of walking practice, 3 descending stairs and 3 single leg jumping practice trials before data collection to familiarize themselves with the evaluated activities. After a 3 minutes rest interval, we will collect the GM EMG activity during the testing procedures.
To evaluate the GM EMG activity during walking, the subjects will walk during 1 minute on a motor driven treadmill matching a cadence of 117 steps/min monitored with a digital metronome (Quick Time QT-05).
The descending stairs activity will be evaluated in a 3 steps custom made stairs with a height of 20 cm and depth of 27,5 cm. Subjects will be told to stop at the top of the stairs and wait for instructions to descend. After the command “ready, set, go”, the subjects will be instructed to step down first with their evaluated limb at a rate of 154 steps/min controlled by a digital metronome. Subjects will performe two trials with a rest interval of 1 minute between them. Only data for the first step down will be analyzed.
To evaluate the single leg vertical jump, the subjects will performe 3 single leg jump as high as possible after the verbal command “ready, set, go”. It will be given one minute rest interval between each test. Subjects will be asked to begin the single leg jump with the non evaluated limb and to land with the evaluated limb.
Intervention code [1] 255932 0
Not applicable
Comparator / control treatment
there is no treatment in this study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257724 0
This is a cross-sectional study without treatment. It will be evaluated the electromiographic activation from gluteus medius in females with and without patellofemoral pain.
Timepoint [1] 257724 0
The electromiographic testing will be assessed during a single 60 minute testing session
Secondary outcome [1] 263086 0
there is no secondary outcome
Timepoint [1] 263086 0
there will be no timepointss

Eligibility
Key inclusion criteria
Inclusion criteria for the patellofemoral pains syndrome (PFPS) group will be as follow: (1) anterior or retropatellar knee pain during at least three of the following activities: ascending/descending stairs, squatting, running, kneeling, hopping/jumping and prolonged sitting; (2) insidious onset of symptoms being unrelated to a traumatic incident; (3) pain during at least four weeks; and (4) the presence of pain on palpation of the patellar facets, on stepping down from a 25-cm step, or during a double-legged squat.
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects from both the PFPS and control groups will be excluded if they show signs or symptoms of any of the following: (1) meniscal or other intra-articular pathological conditions; (2) cruciate or collateral ligament involvement; (3) tenderness of the patellar tendon, iliotibial band, or pes anserinus tendons; (4) patellar apprehension sign; (5) Osgood-Schlatter or Sinding-Larsen-Johansson syndromes; (6) hip pain; (7) back pain; (8) sacroiliac joint pain; (9) history of patellar dislocation; (10) evidence of a knee joint effusion; or (11) previous surgery of the patellofemoral joint.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
19
Accrual to date
Final
Recruitment outside Australia
Country [1] 2447 0
Brazil
State/province [1] 2447 0
Sao Carlos

Funding & Sponsors
Funding source category [1] 256427 0
Government body
Name [1] 256427 0
National Council for Scientific and Technological Development (CNPq)
Country [1] 256427 0
Brazil
Primary sponsor type
Government body
Name
Sao Paulo State Research Foundation (FAPESP)
Address
R. Pio XI, 1500 - Alto da Lapa - CEP 05468-901 - Sao Paulo/SP - Brasil
Country
Brazil
Secondary sponsor category [1] 255731 0
None
Name [1] 255731 0
Address [1] 255731 0
Country [1] 255731 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258483 0
Sao Carlos Federal University Ethics Commitee
Ethics committee address [1] 258483 0
UNIVERSIDADE FEDERAL DE SAO CARLOS
PRO-REITORIA DE PESQUISA
Rod. Washington Luis, km 235
Caixa Postal 676
CEP: 13.565-905 - Sao Carlos - SP
Ethics committee country [1] 258483 0
Brazil
Date submitted for ethics approval [1] 258483 0
04/08/2006
Approval date [1] 258483 0
30/08/2006
Ethics approval number [1] 258483 0
219/2006

Summary
Brief summary
The primary purpose is to investigate the activity of this muscle before the foot contact to see if there was any difference during this specific time when walking, descending stairs or jumping in females with and without PFPS. It is hypothesized that females PFPS subjects will demonstrate delayed GM onset time during the evaluated activities when compared to the pain-free controls. We also hypothesize that the GM EMG signal amplitude will be diminished in the PFPS group during the tasks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30779 0
Address 30779 0
Country 30779 0
Phone 30779 0
Fax 30779 0
Email 30779 0
Contact person for public queries
Name 14026 0
Fabio Viadanna Serrao
Address 14026 0
Departamento de Fisioterapia,
Rod. Washington Luis, km 235 – CEP: 13565-905
Sao Carlos –SP – Brasil
Country 14026 0
Brazil
Phone 14026 0
+55 16 33518754
Fax 14026 0
Email 14026 0
fserrao@ufscar.br
Contact person for scientific queries
Name 4954 0
Fabio Viadanna Serrao
Address 4954 0
Departamento de Fisioterapia,
Rod. Washington Luis, km 235 – CEP: 13565-905
Sao Carlos –SP – Brasil
Country 4954 0
Brazil
Phone 4954 0
+55 16 33518754
Fax 4954 0
Email 4954 0
fserrao@ufscar.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseElectromyographic preactivation pattern of the gluteus medius during weight-bearing functional tasks in women with and without anterior knee pain. [Portuguese]2011https://dx.doi.org/10.1590/S1413-35552011005000003
N.B. These documents automatically identified may not have been verified by the study sponsor.