The purpose of this study is to evaluate the effect of core postural control training using unstable sitting on pain and function in patients with patellofemoral pain syndrome. Patients with patellofemoral pain syndrome complaining gradual anterior knee pain during last 3 months and age between 18 to 45 years old are included. The patients with any previous knee trauma or other pathologies such as meniscus and ligament injuries are excluded. Minimal sample size for this study was determined as 15 patients in each group. Patients will randomly assigned either to control or intervention groups. Both groups will receive conventional physical therapy exercises for patellofemoral pain syndrome during 4 weeks (12 sessions), while the intervention group will receive core postural control training using unstable sitting devise as well. Variables including pain intensity, function via Kujula questionnaire, functional step down test and postural control of trunk and core region will be measured for each patient in first and 12th sessions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120415932N12
Registration date:2017-01-07, 1395/10/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-07, 1395/10/18
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 Faculty of Shiraz University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-06-05, 1396/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of postural control training using unstable sitting on knee joint pain and function in patients with patellofemoral pain syndrome
Public title
The effect of core training using unstable sitting in patients with patrllofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women aged 18 to 45 years old with unilateral or bilateral patellofemoral pain syndrome; anterior or retropatellar knee pain during at least 2 following activities: prolonged sitting, ascending or descending stair,squatting, kneeling, jumping and running; pain on palpation of medial and lateral patellar facets and positive patellar grind test; an insidious onset of symptoms not related to trauma for the last 3 months; Kujula scores less than 85 out of 100; numeric rate scale scores ranging 3 to 10 during last week.
Exclusion criteria: Other knee joint pathologies such as meniscus and ligament injuries, osteoarthritis and tendon impairments; patellar subluxations or dislocations; referral pain from other joints including lumbar spine, hip and sacroiliac joints and spinal fractures; previous knee surgery; neuromuscular, metabolic and rheumatology diseases; pregnancy.
Age
From 18 years old to 45 years old
Gender
Female
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)
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 Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand street, Shiraz
City
Shiraz
Postal code
Approval date
2016-07-17, 1395/04/27
Ethics committee reference number
IR.SUMS.REC.1395.69
Health conditions studied
1
Description of health condition studied
Patellofemoral pain syndrome
ICD-10 code
M22.2
ICD-10 code description
Patellofemoral disorders
Primary outcomes
1
Description
Postural control of trunk and core
Timepoint
First and 12th sessions
Method of measurement
Force plate
2
Description
Pain intensity
Timepoint
First and 12th sessions
Method of measurement
Numeric Rate Scale (NRS)
Secondary outcomes
1
Description
Functional steping
Timepoint
First and 12th sessions
Method of measurement
Step down test
2
Description
Function
Timepoint
First and 12th sessions
Method of measurement
kujula questionnaire
Intervention groups
1
Description
Intervention group: The same as control group plus postural control training exercise using unstable sitting. Patients will be asked to control their balance on unstable sitting and hold it as long as possible (3 set, 6 minutes). In order to progress the training, 3 unstable sitting with 3 different diameters (24, 30 and 50 cm) are provided.
Category
Rehabilitation
2
Description
Control group: Stretching exercises for quadriceps, hamstring, illiotibial band and calf muscles (3 repetition, 30 second hold); quadriceps setting, terminal knee extention, straight leg raise and hip abductor and external rotator strengthening exercise (3 set, 10 second hold).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy clinic of Shiraz School of Rehabilitation
Full name of responsible person
Dr. Alireza Motealleh
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Shiraz University of Medical Sciences Building, Zand Street,shiraz.
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
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, Rehablitation Science Faculty
Full name of responsible person
Forouzan Foroughi
Position
Master science student of Physical Therapy
Other areas of specialty/work
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3843 2206
Fax
Email
foroughi.forouzan13@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Rehabilitation Sciences Faculty
Full name of responsible person
Dr. Alireza Motealleh
Position
PhD of Physiotherapy
Other areas of specialty/work
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1626 1081
Fax
Email
motealleh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science, Rehabilitation Sciences Faculty
Full name of responsible person
Forouzan Foroughi
Position
Master science student of Physical Therapy
Other areas of specialty/work
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Postal code
Phone
00
Fax
Email
foroughi.forouzan13@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)