The aim of present study was evaluation the effectiveness of lumbosacral manipulation versus knee exercise in patients with patellofemoral pain Syndrome in 501 Artesh hospital in 1396.
Design
Clinical trial with a control group with parallel groups, one-blind, randomized.
Settings and conduct
This study was conducted as a clinical trial in Imam Reza Hospital and in patients with patellofemoral pain, this is a one-blind study in which patients will blinded. This is in phase 4 and in this 18 patients with a block method are divided into two groups, 9 patients in intervention group and receive manipulation, and 9 patients in control and receiving routine treatment. Based on this, at first and one month after starting treatment, patellofemoral pain is assessed.
Participants/Inclusion and exclusion criteria
Patients with patellofemoral syndrome, referring to the medical physics clinic of 501 hospital with satisfaction to participate in the study was included in the study, also patients with radiculopathy, osteoarthritis tibiofemoral grade 2 and higher, history of knee surgery and history of knee trauma, will excluded from the study.
Intervention groups
In the control group, only knee exercises were used, and in the intervention group, lumbosacral manipulation with knee exercises were used.
Main outcome variables
Patellofemoral Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039324N1
Registration date:2019-04-06, 1398/01/17
Registration timing:registered_while_recruiting
Last update:2019-04-06, 1398/01/17
Update count:0
Registration date
2019-04-06, 1398/01/17
Registrant information
Name
Sirous Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4382 3476
Email address
s.azizi@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-06, 1398/01/17
Expected recruitment end date
2019-11-08, 1398/08/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Lumbosacral Manipulation versus knee exercise in patients with Patellofemoral Pain Syndrome
Public title
Evaluation of the effectiveness of Lumbosacral Manipulation in patients with Patellofemoral Pain Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patellofemoral syndrome
Referring to the Medical Physics Clinic of 501 hospital
Satisfaction to participate in the study
Exclusion criteria:
Radiculopathy
Tibiofemoral Osteoarthritis Grade 2 and higher
History of knee surgery
History of knee trauma
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization is done with sealed envelope tools in such a way that the letters A and B are inserted in the envelopes and patients are asked to select an envelope that the intervention group A and the group B they will be tested.
Blinding (investigator's opinion)
Single blinded
Blinding description
This means that patients in any groups do not know the used approaches in another group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Medical University for the Islamic Republic of Iran's Army
Street address
1411718541, Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2018-06-01, 1397/03/11
Ethics committee reference number
IR.AJAUMS.REC.1397.006
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
Patellofemoral Pain
Timepoint
Initially and one month after the intervention
Method of measurement
Radiographic examinations include AP, Lateral and Patellar View of the knee as well as Lumbosacral Manipulation group with walking analysis and range of motion knee.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group lumbosacral manipulation with knee exercises are used.
Category
Treatment - Devices
2
Description
Control group: In this group only knee exercises are used.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Elahe Shirzadi
Street address
1411718541, Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
elaheh_shirzady@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mostafa Shahrezaee
Street address
1411718541, Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
moshahrezayee@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Elahe Shirzadi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
1411718541, Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
elaheh_shirzady@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Elahe Shirzadi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
1411718541, Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
elaheh_shirzady@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Elahe Shirzadi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
1411718541, Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
elaheh_shirzady@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available