Protocol summary

Summary
This study is a randomized controlled trial to compare the fiber angle ratio of vastus medialis obliquus to vastus lateralis in patient with patellofemoral pain syndrome before and after quadriceps strengthening. Sixty subjects with patellofemoral between 12 and 40 years of ages will randomly assigned in 2 groups; the exercise group and control group. The quadriceps strength in patient with patellofemoral pain syndrome measures by using an isokinetic dynamometer and the fiber angle of the vastus medialis obliquus and vastus lateralis will be assessed by ultrasonography. Intervention consisted of 4 weeks of quadriceps strengthening. At the end of 4 weeks All measurements will be performed again.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014093019346N1
Registration date: 2014-12-19, 1393/09/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-12-19, 1393/09/28
Registrant information
Name
Roshanak Honarpisheh
Name of organization / entity
Semnan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 8882 8947
Email address
r.honarpisheh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of quadriceps muscle strengthening exercises on the fiber angle ratio of vastus medialis obliquus to vastus lateralis in patient wit patellofemoral pain syndrome
Public title
Effect of quadriceps muscle strengthening exercises on the fiber angle ratio of vastus medialis obliquus to vastus lateralis in patient wit patellofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: peripatellar or retropatellar pain provoked by at least 2 of the following activities: prolonged sitting with flexed knees, stair climbing, squatting, running, kneeling, and jumping(including landing after a jump); exhibition of 2 or more of the following clinical criteria on assessment: pain on direct compression of the patella against the femoral condyles with the knee in full extension, tenderness on palpation of the posterior edge at the medial and/or lateral border of the patella, and pain on direct compression of the patella against the femur during isometric quadriceps contraction with the knee in slight flexion; age between 12 and 40 years old; the presence of patellofemoral pain for a minimum of 3 months. Exclusion criteria: history or evidence of other knee disorders like ligament injury, bursitis, meniscal injury, or osteoarthritis; lower limb surgery or trauma during last year; patellar instability; referred pain from the lumbar spine and ankle joint; existence of any abnormality in lower limb and spine; loss of flexibility of the soft tissue structures such as the quadriceps, hamstrings, triceps surae; the position and mobility of the subject's patella were then clinically assessed using the method described by McEwan et al. The subjects were also excluded if their patellae demonstrated lateral deviation greater than 5 mm; lateral patella tilt; hypo or hypermobility on medial glide of the patella.
Age
From 12 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Semnan university of medical science
Street address
Semnan university of medical science-Semnan-Iran
City
Semnan
Postal code
Approval date
2014-12-16, 1393/09/25
Ethics committee reference number
93/538806

Health conditions studied

1

Description of health condition studied
patellofemoral pain syndrom
ICD-10 code
M22.2
ICD-10 code description
Patellofemoral disorders

Primary outcomes

1

Description
Fiber angles of vastus lateralis
Timepoint
Before intervention and after 4 weeks intervention
Method of measurement
Scale of degrees with ultrasonography

2

Description
Fiber angles of vastus medialis obliquus
Timepoint
Before intervention and after 4 weeks intervention
Method of measurement
Scale of degrees with ultrasonography

3

Description
fiber angle ratio of vastus medialis obliquus to vastus lateralis
Timepoint
Before intervention and after 4 weeks intervention
Method of measurement
Scale of degrees with ultrasonography

Secondary outcomes

1

Description
Quadriceps strength
Timepoint
Before intervention and after 4 weeks intervention
Method of measurement
Newton per meter with biodex dynamometr

Intervention groups

1

Description
Patients in the intervention group perform the quadriceps exercise, three times a week during 4 weeks. exercise protocol include: weeks 1-2: wall squat(0-45 of knee flextion)/15 repetition quadriceps isometric/4 sets of 25 repetitions straight leg raises/3 sets of 10 repetition weeks 3-4: wall squat(0-60 of knee flextion)/15 repetition quadriceps isometric/4 sets of 25 repetition straight leg rise/3 sets of 10 repetition terminal knee extension/3 sets of 10 repetition an exercise log provides for monitoring all subjects .If the load level elicited pain, it will decrease
Category
Rehabilitation

2

Description
The control group do not participate in any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Outpatient clinics of Semnan University of medical sciencess
Full name of responsible person
roshanak honarpisheh
Street address
No.24-neuromuscular rehabilitation research center-Ghods Blvd-Mashahir square-Semnan-Iran
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of research and technology of Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Rashidy pour
Street address
deputy of research and technology of Semnan university of medical sciences-No.47-university of medical sciences-Basij Blvd-Semnan-Iran
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research and technology of Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan university of medical science
Full name of responsible person
Roshanak Honarpisheh
Position
Bachelor
Other areas of specialty/work
Street address
rehabilitation school-Semnan university of medical sciences--Damghan road-Semnan-Iran
City
Semnan
Postal code
Phone
+98 21 8882 8947
Fax
Email
r.honarpisheh@semums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan university of medical sciences
Full name of responsible person
Roshanak Honarpisheh
Position
Bachelor
Other areas of specialty/work
Street address
rehabilitation school-Semnan university of medical sciences--Damghan road-Semnan-Iran
City
Semnan
Postal code
Phone
+98 21 8882 8947
Fax
Email
r.honarpisheh@semums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan university of medical sciences
Full name of responsible person
Roshanak Honarpisheh
Position
Bachelor
Other areas of specialty/work
Street address
rehabilitation school-Semnan university of medical sciences-Damghan road-Semnan-Iran
City
Semnan
Postal code
Phone
+98 21 8882 8947
Fax
Email
r.honarpisheh@semums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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