Protocol summary

Summary
The goal of this research is to evaluate the effects of core neuromuscular training on pain, balance and functional performance in women with patellofemoral pain syndrome. Inclusion criteria for this study are: anterior knee pain in recent 2 months; positive patellar grind test; kujala score ranging from 50 to 80; visual analog score ranging from 3 to 10. Exclusion criteria for this study are: other knee joint pathologies such as meniscus and ligament injuries, osteoarthritis, tendon impairments and patellar dislocations; referral pain from other joints; lower extremity surgeries; neuromuscular and metabolic diseases. 28 females with PFPS are randomly assigned into intervention (14 people) and control group (14 people). Both groups receive the same conventional physical therapy for 4 weeks, while intervention group receive core stabilization exercise as well. Balance, performance and pain in both groups are assessed by Y balance test, kujala questionnaire, step down test and VAS before and after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014021315932N2
Registration date: 2014-08-16, 1393/05/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-08-16, 1393/05/25
Registrant information
Name
Alireza Motealleh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 5108
Email address
motealleh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rehabilitation school, Shiraz University of Medical Sciences
Expected recruitment start date
2013-02-22, 1391/12/04
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effects of core stabilization exercise on balance,performance and pain in individuals with patellofemoral pain syndrome
Public title
The effects of trunk stabilization exercise on anterior knee pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: anterior knee pain in recent 2 months; gradual and non traumatic onset of symptoms; positive patellar grind test; kujala score ranging between 50 to 80; visual analog score ranging from 3 to 10 in last past month. Exclusion criteria: other knee joint pathologies such as meniscus and ligament injuries,osteoarthritis,tendon impairments and patellar dislocations; hip and lumbar referral pain; previous lower extremity surgeries; neuromuscular and methabolic diseases such as diabet; cardiac disorders impeding exercise
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Science
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz, Fars, Iran
City
Shiraz
Postal code
Approval date
2013-10-06, 1392/07/14
Ethics committee reference number
CT-P-92-5724

Health conditions studied

1

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

2

Description of health condition studied
Chondromalacia patellae
ICD-10 code
M22.4
ICD-10 code description
Chondromalacia patellae

Primary outcomes

1

Description
Pain
Timepoint
Immediately before treatment -immediately after treatment (after 4 weeks)
Method of measurement
VAS

2

Description
Balance
Timepoint
Immediately before treatment -immediately after treatment (after 4 weeks)
Method of measurement
Star excursion balance test

3

Description
knee Function
Timepoint
Immediately before treatment -immediately after treatment (after 4 weeks)
Method of measurement
kujala questionnaire and Knee performance tests

Secondary outcomes

empty

Intervention groups

1

Description
control group: 1.Hamstring, ITB and gastrocnemius stretching 30 sec hold for 5 repetitions 2. Quadriceps setting: 10 repetition 10 sec hold 3. SLR: 3 set 10 seconds hold 4. Forward step up: 3 set of 10 repetitions 5. Squat with 30˚ knee flexion: 3 set 10 seconds hold 6. Lateral step up: 3 set 10 seconds hold
Category
Rehabilitation

2

Description
Intervention group: the same as control group plus following core neuromuscular training: 1-bridging while holding a small ball between knees (3 set 10 seconds hold) 2- sidelying hip abduction(clam exercise)(6 repeat 10 seconds hold) 3-Lat SLR (3 set 10 seconds hold) 4-curl up while holding a small ball between bent knees (5 repeat 10 seconds hold) 5-Isometric hip abduction in standing position (15 repeat 5 seconds hold) 6-Intermitent shoulder flexion/extension while standing on afflicted limb (15 repeat 5 seconds hold) 7-Trunk rotation toward healthy side While maintaining hip internal rotation in standing position on the afflicted leg (15 repeat 5 seconds hold) 8- curl up while holding a small ball between straight knees (6 repetition 10 seconds hold) 9- Lat curl up while holding a small ball between straight knees(6 repetition 10 seconds hold
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation school, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Alireza Motealleh
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz, Fars, Iran
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences, Rehabilitation School
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz, Fars, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences, Rehabilitation School
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
Shiraz University of Medical Sciences
Full name of responsible person
Nazanin Nejati
Position
Student
Other areas of specialty/work
Street address
Abrishami Street, Gaz Square, Shiraz,Fars, Iran
City
Shiraz
Postal code
Phone
+98 71 1227 5139
Fax
Email
nazinej@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Alireza Motealleh
Position
Assistant professor of physiotherapy
Other areas of specialty/work
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz ,Fars, Iran
City
Shiraz
Postal code
Phone
+98 71 1626 5108
Fax
Email
motealleh@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Dr. Alireza Motealleh
Position
Assistant professor
Other areas of specialty/work
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz ,Fars, Iran
City
Shiraz
Postal code
Phone
+98 71 1626 5108
Fax
Email
motealleh@sums.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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