Comparative effect of Functional Patellofemoral Joint Mobilizations and Open-Pack Patellofemoral Joint Mobilization for Patellofemoral Pain Syndrome; A Randomized Clinical Trial.
To compare functional patellofemoral joint mobilizations with the standard
open-pack patellofemoral joint mobilization for reducing pain associated with
patellofemoral pain syndrome.
Design
A single blinded quantitative study ,following the research design of randomized control trial. Randomization will be through coin tossing method. Active control group will be used to compare the results
Settings and conduct
Subjects with patellofemoral pain syndrome will be taken from these 3 hospital settings:
Allied hospital Faisalabad, District
Headquater hospital Faisalabad and Madinah Teaching Hospital Faisalabad.
Blinding: participants will be blinded they will not be aware whether they are in treatment or control group as the participants of both the groups will receive 3 step intervention .Physiotherapist will provide different mobilization to each group which will be hidden from the subjects.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Subjects having pain in the knee associated with, during or after the activity including stair
ascending/descending, squatting, jumping, prolonged sitting etc. Non-inclusion criteria: Meniscal injury or any other articular injury; Knee ligament laxity; History of recent knee surgery; History of recent patellar dislocation.
Intervention groups
Intervention group 1:
1. Hot pack (10 min) .
2. Functional patellofemoral joint mobilizations(medial patellofemoral glide in 4 functional positions)
3. Baseline quadricep strengthening exercise program.
Intervention group 2:
1.Hot pack (10 min) .
2.Baseline quadricep strengthening exercise program.
3.Grade I-11 Medial patellofemoral mobilizations (in one position only).
Comparative effect of Functional Patellofemoral Joint Mobilizations and Open-Pack Patellofemoral Joint Mobilization for Patellofemoral Pain Syndrome; A Randomized Clinical Trial.
Public title
Effect of Patellofemoral Joint Mobilizations for knee pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients at the age of 18-35 years old
Both gender
Willingness to participate in the research
Willingness for random allocation to either of the two groups
Pain in the knee associated with, during or after the activity including stair ascending/descending, squatting, jumping, prolonged sitting etc
Insidious onset of pain that is unrelated to trauma
Patient having at least one positive test from these physical tests: 1)Patellofemoral grind test. 2) Patellar apprehension test.3) Step down test
Visual analogue scale rating of anterior knee pain during daily activities at a minimum of 30 mm to 70 mm on 100 mm scale
Exclusion criteria:
Meniscal injury or any other articular injury.
Knee ligament laxity.
History of recent knee surgery
History of recent patellar dislocation
NSAID or corticosteriod drug use before testing within 24 hours
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Sample will be allocated to Group A (Functional mobilization) and Group B (Open pack mobilization) randomly using coin tossing.
Method of randomization: Simple randomization
Tool for randomization: Sealed envelopes
Unit of randomization: Individual
Allocation will be concealed from the participants, they will not know whether they are in the treatment or control group,
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants of both groups will be unaware whether they are in active control group or the treatment group after taking informed consent from them. Participants of both groups will receive the same baseline treatment that is quadriceps strengthening exercises. After that Physiotherapist will apply different types of knee mobilizations to both groups of which the participants will be unaware of.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of The University of Faisalabad
Street address
4-km,Sargodha Road, University Town, Faisalabad, Pakistan.
City
Faisalabad
Postal code
38000
Approval date
2022-04-07, 1401/01/18
Ethics committee reference number
TUF/DR/MSPP/322
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
Pain in the anterior knee
Timepoint
Pain level will be measured before applying the intervention and then after 4 weeks after the completion of intervention.
Method of measurement
Visual Analogue scale and anterior knee pain scale will be used to measure the pain.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (Group A) ; 1. Hot pack (10 min) 2.Grade 1-11 Functional patellofemoral joint mobilizations 3.Baseline Quadriceps strengthening exercise program.
Category
Rehabilitation
2
Description
Control group: Hot pack (10 min) 2.Grade 1-11open-pack patellofemoral joint mobilizations 3.Baseline Quadriceps strengthening exercise program.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Madinah Teaching Hospital
Full name of responsible person
Dr. Sidra Majeed
Street address
Sargodha Rd, University Town, Faisalabad, Punjab, Pakistan.
City
Faisalabad
Postal code
38000
Phone
+92 334 7731241
Email
info@mth.org.pk
2
Recruitment center
Name of recruitment center
Allied Hospital Faisalabad
Full name of responsible person
Dr. Sidra Majeed
Street address
Jail Road adjacent Faisalabad Medical University, Near Sargodha Road, Faisalabad,Pakistan
City
Faisalabad
Postal code
38000
Phone
+92 334 7731241
Email
sidra.majeed@tuf.edu.pk
3
Recruitment center
Name of recruitment center
DHQ hospital Faisalabad
Full name of responsible person
Dr.Sidra Majeed
Street address
Near Railway Station, Mall Road, Faisalabad, Pakistan
City
Faisalabad
Postal code
38000
Phone
+92 334 7731241
Email
sidra.majeed@tuf.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Sidra Majeed, PT
Street address
4-km Sargodha road, University Town, Faisalabad, Pakistan
City
Faisalabad
Postal code
38000
Email
sidra.majeed@tuf.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The University of Faisalabad
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Sidra Majeed,PT
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
4-km Sargodha road, University town, Faisalabad, Pakistan
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 334 7731241
Email
sidra.majeed@tuf.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Laiba Nadeem
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no 12,sahil homes, mian zulfiqar ali shahid road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 308 6511400
Fax
Email
dpt-fa14-097@tuf.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Laiba Nadeem
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no 12,sahil homes, mian zulfiqar ali shahid road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 308 6511400
Fax
Email
dpt-fa14-097@tuf.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
All collected deindentified participant data set for the outcome measures.
When the data will become available and for how long
4 months after publication
To whom data/document is available
People working in the academic institutions
Under which criteria data/document could be used
IPD and any any additional supporting documents will be provided for the research on the similar topic and can be obtained by asking through the contact person mentioned below