Comparison of McKenzie Extension Exercise versus Mulligan Sustained Natural Apopheseal Glides on Pain, Range of Motion and Functional Disability in Patients with Acute Non- Specific Low Back Pain
To compare the effects of McKenzie Extension Exercises versus Mulligan Sustained Natural Apophyseal Glides on Pain, Range of motion and Functional Disability in patients with Acute Non-Specific Low Back Pain
The study would be double blinded as participants and assessors of the study would be kept blind of the treatment group and will be done at Physiotherapy Department Gosh-e-Shifa Hospital Gulshan Ravi, Lahore.
Participants/Inclusion and exclusion criteria
inclusion criteria: A patient with history of acute non specific Low Back Pain, Patients of both Gender, Age range 20-50 Years and only Married people will include in study. Exclusion criteria: Any neurological symptoms, Any pathology of spine like Spondylosis, Spondylolisthesis, Patients with other comorbidity such as systemic disorders, Patients with sociopsychatric disorders and Pregnancy.
Intervention groups
Randomly, treatment will be assigned to patients in this study In Group 1 participants will receive routine physical therapy (10 minutes hot pack, 5 minutes TENS, 5 minutes soft tissue massage) along with McKenzie Extension Exercises in prone position with repeated movements. Patient will have 5 repetitions of every set of exercise with 20 seconds of pause in per session. In group 2 participants will receive same routine physical therapy along with Mulligan’s SNAGs in sitting and prone position by applying antereo cranial glide in the direction of treatment plane over the spinous process at 8 repetitions per session.
Main outcome variables
pain, range and functional disability
General information
Reason for update
Acronym
Dileep Kumar
IRCT registration information
IRCT registration number:IRCT20200608047700N1
Registration date:2020-07-22, 1399/05/01
Registration timing:registered_while_recruiting
Last update:2020-07-22, 1399/05/01
Update count:0
Registration date
2020-07-22, 1399/05/01
Registrant information
Name
Dileep Kumar Lohana
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 232 291057
Email address
drdileeplumhs@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-19, 1398/12/29
Expected recruitment end date
2020-09-19, 1399/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of McKenzie Extension Exercise versus Mulligan Sustained Natural Apopheseal Glides on Pain, Range of Motion and Functional Disability in Patients with Acute Non- Specific Low Back Pain
Public title
Acute Non- Specific Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
•Patient with history of acute non specific Low Back Pain
Either gender
age ranges from 20-50 years
only Married people will include in study
Exclusion criteria:
•Any neurological symptoms
Any pathology of spine like Spondylosis, Spondylolisthesis
Patients with other comorbidity such as systemic disorders
•Patients with sociopsychatric disorders
Pregnancy
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be performed by selection of a participant place odd and even number in two different groups
Blinding (investigator's opinion)
Double blinded
Blinding description
This will be double blind study as the assessor and participant will not be disclosed about the study group. The data will be collected by assessor and will be provided to the researcher.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of The University of Lahore "Institutional Review Board"
Street address
defence road campus,new campus ,The University of Lahore
City
lahore
Postal code
54000
Approval date
2020-03-04, 1398/12/14
Ethics committee reference number
IRB-UOL-FAHS/716-II/2020
Health conditions studied
1
Description of health condition studied
acute low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain Intensity
Timepoint
before intervention and then on 4th and 8th week
Method of measurement
Visual analogue scale
2
Description
Lumbar Range of motion
Timepoint
before intervention and then on 4th and 8th week
Method of measurement
Back Performance Scale
3
Description
Functional Disability
Timepoint
before intervention and then on 4th and 8th week
Method of measurement
Oswetry Low Back Pain Disability Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants will receive routine physical therapy (10 minutes hot pack, 5 minutes TENS, 5 minutes soft tissue massage) along with McKenzie Extension Exercises in prone position with repeated movements. Patient will have 5 repetitions of every set of exercise with 20 seconds of pause in per session.
Category
Rehabilitation
2
Description
Control group: Participants will receive routine physical therapy (10 minutes hot pack, 5 minutes TENS, 5 minutes soft tissue massage) along with Mulligan’s SNAGs in sitting and prone position by applying antereo cranial glide in the direction of treatment plane over the spinous process at 8 repetitions per session.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Department Gosh-e-Shifa Hospital Gulshan Ravi, Lahore.
Full name of responsible person
Dr Aisha Tahir
Street address
759-A Block Gulshan-e-Ravi Lahore
City
lahore
Postal code
same as address
Phone
+92 42 37413842
Email
info@grwtrust.org
Web page address
http://www.grwtrust.org/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of lahore
Full name of responsible person
Waqar Afzal
Street address
1-Km Defence Road، Near Bhuptian Chowk، Lahore
City
lahore
Postal code
54000
Phone
+92 42 37812194
Email
waqarafzal621@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The University of Lahore
Proportion provided by this source
60
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gosha e shifa Hospital
Full name of responsible person
Dileep Kumar Lohana
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
759-A Block Gulshan-e-Ravi, Lahore
City
lahore
Province
punjab
Postal code
54500
Phone
+92 42 37413842
Email
info@grwtust.org
Web page address
http://www.grwtrust.org/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gosha e Shifa Hospital
Full name of responsible person
Dileep Kumar Lohana
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
759-A Block Gulshan-e-Ravi, Lahore
City
lahore
Province
punjab
Postal code
54500
Phone
+92 42 37413842
Email
info@grwtrust.org
Web page address
http://www.grwtrust.org/
Person responsible for updating data
Contact
Name of organization / entity
Gosha e Shifa Hospital
Full name of responsible person
Dileep Kumar Lohana
Position
physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
759-A Block Gulshan e Ravi, Lahore
City
lahore
Province
punjab
Postal code
54500
Phone
+92 42 37413842
Email
info@grwtrust.org
Web page address
http://www.grwtrust.org/
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
Comparison of McKenzie Extension Exercise versus Mulligan Sustained Natural Apopheseal Glides on Pain, Range of Motion and Functional Disability in Patients with Acute Non- Specific Low Back Pain and all collected deidentified IPD will be shared.
When the data will become available and for how long
After Publication
To whom data/document is available
people working in academic institutions and researchers
Under which criteria data/document could be used
it could be used on request
From where data/document is obtainable
Through Email and phone drdileeplumhs@gmail.com
What processes are involved for a request to access data/document
Through Email and phone drdileeplumhs@gmail.com 0092 331 3837764
Comments
data can bee provided on request but after publication