To compare the outcome of open kinetic chain and close kinetic chain neuromuscular training to reduce pain and improve functional status in patients with patellofemoral pain syndrome
Design
Two arms parallel-group randomized controlled trial in which 60 patients (30 in each group) will be assigned into two groups
Settings and conduct
The sampling frame formed for all the diagnosed patients with patellofemoral pain syndrome, presenting to the physiotherapy department of Mayo Hospital, Lahore, and through a simple random sampling technique sample will be drawn. After taking consent from the patients, the patients fulfilling the inclusion and exclusion criteria will be selected for the study. Patients and assessors will be blind regarding the treatment groups.
Participants/Inclusion and exclusion criteria
All patients between the age of 18 to 30 years, diagnosed cases of Patellofemoral pain syndrome on the basis of history and physical examination will be included in this study.
Patients with a history of surgery, trauma, dislocation of patella, degenerative joint disease, cardiac or locomotor disorders documented in history or history of any instability of knee due to meniscal or ligament injury confirmed by physical examination will be excluded.
Intervention groups
Intervention group 1: neuromuscular close kinetic chain group. Intervention group 2: neuromuscular open kinetic chain
The comparison of effectiveness of open kinetic chain and close kinetic chain neuromuscular training in patients with patellofemoral pain syndrome
Public title
Effect of exercises in Anterior Knee Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnose cases of Patellofemoral pain syndrome on the basis of history and physical examination as anterior knee pain from more than 2 months during at least two of the following activities: remaining seated for a prolonged time; going up or down stairs; squatting; running and jumping .
Positive findings in any of the test: i: Patellar grind test, ii: Resisted isometric quadriceps femoris muscle contraction test (pain in 2 out of 3 contraction is consider positive), iii: Eccentric step testing, iv: Increase in Q- angle, v:Ischiotibial muscles shortening, defined as a loss of more than 30 degrees of leg extension with thigh positioned at 90 degrees of flexion , vi: Positive patellar compression test
Exclusion criteria:
History of surgery, trauma, dislocation of patella, degenerative joint disease, cardiac or locomotor disorders documented in history
Chronic instability of the knee
Disorders associated with meniscal and/or ligamentous injuries confirmed by physical examination.
Age
From 18 years old to 30 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A sampling frame will be formed for all the diagnosed patients with patellofemoral pain syndrome, presenting to the physiotherapy department of Mayo Hospital through simple random sampling technique sample will be drawn and patients will be randomized blindly and assigned through a computer-generated random number table via opaque concealed envelops into two groups i.e. group 1 (neuromuscular close kinetic chain group), group 2 (neuromuscular close kinetic chain).
Blinding (investigator's opinion)
Double blinded
Blinding description
Clinical parameters like pain, functional status and Quadricep angle will be collected through VAS ,Kujala anterior knee pain scale and Q-angle measurement, and will be noted before and after the treatment by different accessor than the one who apply the treatment. Patients in both groups will be blind regarding the treatment in other group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institution review board committee of King Edward Medical University, Lahore
Street address
Nelagumbad, Anarkali
City
Lahore
Postal code
54000
Approval date
2019-08-21, 1398/05/30
Ethics committee reference number
1036/RC/KEMU
Health conditions studied
1
Description of health condition studied
Patellofemoral Pain syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
before intervention and 4 weeks after the intervention
Method of measurement
Visual Analogue scale
2
Description
Functional status
Timepoint
before intervention and 4 weeks after the intervention
Method of measurement
Kujala Anterior knee pain scale
3
Description
Q angle
Timepoint
before intervention and 4 weeks after the intervention
Method of measurement
Goniometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: neuromuscular closed kinetic chain group Week 1: Setting Exercises for Co-Contraction: :2 sets of 10 repetition with 3 second hold in each repetition and 1 minute interval between the each set , Alternating Isometrics and Rhythmic Stabilization: 2 sets of 10 repetition with 3 second hold in each repetition and 1 minute interval between the each set, Scooting on a Wheeled Stool: :2 sets of 10 repetition and 1 minute interval between the each set, Partial Squats: 2 sets of 10 repetition without hold and 1 minute interval between the each set ,Week 2: Setting Exercises for Co-Contraction: :2 sets of 10 repetition with 5 second hold in each repetition and 1 minute interval between the each set, Alternating Isometrics and Rhythmic Stabilization: :2 sets of 10 repetition with 5 second hold in each repetition and 1 minute interval between the each set, Scooting on a Wheeled Stool: :3 sets of 10 repetition and 1 minute interval between the each set, Partial Squats :2 sets of 10 repetition with 3 second hold and 1 minute interval between the each set, Closed-Chain Isometrics against Elastic Resistance: 2 sets of 10 repetition and 1 minute interval between the each set , Unilateral Closed-Chain Terminal Knee Extension: 2 sets of 10 repetition and 1 minute interval between the each set , Close chain hip abduction: 2 sets of 10 repetition and 1 minute interval between the each set , Week 3: Setting Exercises for Co-Contraction: :3 sets of 10 repetition with 5 second hold in each repetition and 1 minute interval between the each set ,Alternating Isometrics and Rhythmic Stabilization: :3 sets of 10 repetition with 5 second hold in each repetition and 1 minute interval between the each set. Partial Squats :3 sets of 10 repetition with 5 second hold and 1 minute interval between the each set, Closed-Chain Isometrics against Elastic Resistance: 3 sets of 10 repetition and 1 minute interval between the each set, Unilateral Closed-Chain Terminal Knee Extension: 3 sets of 10 repetition and 1 minute interval between the each set , Forward, Backward, and Lateral Step-Ups and Step-Downs: 2 sets of 10 repetition and 1 minute interval between the each set , Partial Lunges: 2 sets of 10 repetition and 1 minute interval between the each set, Close chain hip abduction: 3 sets of 10 repetition with 5 second hold and 1 minute interval between the each set , Week 4:Setting Exercises for Co-Contraction: :3 sets of 10 repetition with 10 second hold in each repetition and 1 minute interval between the each set, Alternating Isometrics and Rhythmic Stabilization: :3 sets of 10 repetition with 10 second hold in each repetition and 1 minute interval between the each set ,Full Squats :3 sets of 10 repetition with 5 second hold and 1 minute interval between the each set Closed-Chain Isometrics against Elastic Resistance: 3 sets of 15 repetition and 1 minute interval between the each set , Unilateral Closed-Chain Terminal Knee Extension: 3 sets of 15 repetition and 1 minute interval between the each set , Forward, Backward, and Lateral Step-Ups and Step-Downs: 3 sets of 10 repetition and 1 minute interval between the each set, Full Lunges: 3 sets of 10 repetition and 1 minute interval between the each set, Close chain hip abduction: 3 sets of 10 repetition with 10 second hold and 1 minute interval between the each set
Category
Rehabilitation
2
Description
Intervention group 2: neuromuscular open kinetic chain , Week 1: Quadriceps Setting (Quad Sets) :2 sets of 10 repetition with 5 second hold in each repetition and 1 minute interval between the each set , Straight-Leg Raise: 1 sets of 10 repetition without hold, Hamstring Setting (Hamstring Sets): 2 sets of 10 repetition with 5 second hold in each repetition and 1 minute interval between the each set , Side lying hip abduction: 1 sets of 10 repetition without hold, Prone hip extension: 1 sets of 10 repetition without hold Week 2: Straight-Leg Raise: 2 sets of 10 repetition with 5 second hold and 1 minute interval between the each set, Side lying hip abduction: 2 sets of 10 repetition with 5 second hold and 1 minute interval between the each set, Prone hip extension: 2 sets of 10 repetition with 5 second hold in each repetition hold and 1 minute interval between the each set, Straight-Leg Lowering: 2 sets of 10 repetition without hold and 1 minute interval between the each set, Multiple-Angle Isometric Exercises (quadriceps and hamstrings ) 2 sets of 10 repetition with 10 second hold and 1 minute interval between the each set, Short-Arc Terminal Knee Extension : 2 sets of 10 repetition with 5 second hold and 1 minute interval between the each set Week 3: Straight-Leg Raise: 2 sets of 10 repetition with 5 second hold and 1 minute interval between the each set (with cuff weight around the ankle), Side lying hip abduction: 2 sets of 10 repetition with 5 second hold and 1 minute interval between the each set (with cuff weight around the ankle), Prone hip extension: 2 sets of 10 repetition with 5 second hold in each repetition hold and 1 minute interval between the each set (with cuff weight around the ankle), Straight-Leg Lowering: 2 sets of 10 repetition and 1 minute interval between the each set (with cuff weight around the ankle), Short-Arc Terminal Knee Extension : 2 sets of 10 repetition with 5 second hold and 1 minute interval between the each set (with cuff weight around the ankle), Hamstring Curls: 2 sets of 10 repetition and 1 minute interval between the each set (with cuff weight around the ankle), Standing hip abduction and extension: 2 sets of 10 repetition and 1 minute interval between the each set (with cuff weight around the ankle• Full-Arc Extension: 2 sets of 10 repetition with 5 second hold in each repetition hold and 1 minute interval between the each set (with cuff weight around the ankle) Week 4: Straight-Leg Raise: 3 sets of 10 repetition with 10 second hold and 1 minute interval between the each set (with cuff weight around the ankle) , Side lying hip abduction: 3 sets of 10 repetition with 10 second hold and 1 minute interval between the each set (with cuff weight around the ankle), Prone hip extension: 3 sets of 10 repetition with 10 second hold in each repetition hold and 1 minute interval between the each set (with cuff weight around the ankle), Straight-Leg Lowering: 3 sets of 10 repetition and 1 minute interval between the each set (with cuff weight around the ankle), Short-Arc Terminal Knee Extension : 3 sets of 10 repetition with 10 second hold and 1 minute interval between the each set (with cuff weight around the ankle), Hamstring Curls: 3 sets of 10 repetition and 1 minute interval between the each set (with cuff weight around the ankle), Standing hip abduction and extension: 3 sets of 10 repetition and 1 minute interval between the each set (with cuff weight around the ankle), Full-Arc Extension: 3 sets of 10 repetition with 10 second hold in each repetition hold and 1 minute interval between the each set (with cuff weight around the ankle)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mayo Hospital, Lahore
Full name of responsible person
Muhammad Saleem Nawaz
Street address
Nelagumbad, Anarkali
City
Lahore
Postal code
54000
Phone
+92 42 99211134
Email
saleem.nawaz1@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
King Edward Medical University, Lahore
Full name of responsible person
Dr Riasat Ali
Street address
Nelagumbad, Anarkali
City
Lahore
Postal code
54000
Phone
+92 42 99213063
Email
registrar@kemu.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
King Edward Medical University, Lahore
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
Mayo Hospital
Full name of responsible person
Amna Zia
Position
Physiotherapist
Latest degree
Specialist
Other areas of specialty/work
Physiotherapy
Street address
Nelagumbad, Anarkali
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 324 4686993
Email
amna_zia_17@live.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mayo Hospital
Full name of responsible person
Amna Zia
Position
Physiotherapist
Latest degree
Specialist
Other areas of specialty/work
Physiotherapy
Street address
Nelagumbad, Anarkali
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 324 4686993
Email
amna_zia_17@live.com
Person responsible for updating data
Contact
Name of organization / entity
Mayo Hospital
Full name of responsible person
Amna Zia
Position
Physiotherapist
Latest degree
Specialist
Other areas of specialty/work
Physiotherapy
Street address
Nelagumbad, Anarkali
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 324 4686993
Email
amna_zia_17@live.com
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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
data sets will be avaible on scientist demand , wishing to use them for non-commercial purposes
When the data will become available and for how long
after the completion of the study
To whom data/document is available
to people working in academic institutions
Under which criteria data/document could be used
on scientist demand, wishing to use them for non-commercial purposes
From where data/document is obtainable
Amna Zia , email Id: amna_zia_17@live.com
What processes are involved for a request to access data/document
Applicant can email to contact person and request the data set