Effects of Lumbar Sustained Natural Appophyseal Glide versus Muscle energy techniques on pain, Range of Motion and function in chronic Nonspecific Low Back Pain.
To compare the effects of Lumbar Sustained Natural Appophyseal Glide and Muscle energy techniques on pain, Range of Motion and function in chronic nonspecific low back pain.
Design
Two parallel group , double blinded, randomized clinical trial with pre and post assessment
Settings and conduct
Riphah Rehab clinic.
Participants and outcome Assessor blind: Data safety will be ensured by
assigning Specific Identity numbers and all consent,
readings forms will be placed in locker to blind assessors
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA:
1. Subject between the ages 25 to 60.
2. Both male and female patients with low back pain.
3. Subject with history of 3 months continues or intermittent symptoms of low back pain.
4. The flexion of trunk at least 40-degree ROM.
EXCLUSION CRITERIA:
1. Patient with history of pathology of spine (spine tumors,spinal infections, spondylosis, neurological deficit, pregnant women).
2. Patient pain will radiate down to the knee.
3. History of spinal surgery.
Intervention groups
Intervention group A: lumber sustained natural appophyseal glide and conventional treatment.
Intervention group B:Muscle Energy Technique (METs) of
Quadratus Lumborum and conventional treatment.
Main outcome variables
Numeric Pain Rating scale (NPRS),Modified Oswestry
disability index (MODI),Lumber inclinometer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200228046639N1
Registration date:2020-09-22, 1399/07/01
Registration timing:registered_while_recruiting
Last update:2020-09-22, 1399/07/01
Update count:0
Registration date
2020-09-22, 1399/07/01
Registrant information
Name
Assra Noor Javed
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 52 3582055
Email address
assra.khan.ak@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-08, 1399/04/18
Expected recruitment end date
2020-12-30, 1399/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Lumbar Sustained Natural Appophyseal Glide versus Muscle energy techniques on pain, Range of Motion and function in chronic Nonspecific Low Back Pain.
Public title
Effects of Lumbar Sustained Natural Appophyseal Glide and Muscle energy technique in Low Back Pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subject between the ages 25 to 60.
Both male and female patients with low back pain.
Subject with history of 3 months continues or intermittent symptoms of low back pain.
The flexion of trunk at least 40-degree ROM.
Exclusion criteria:
Patient with history of pathology of spine (spine tumors,spinal infections, spondylosis, neurological deficit, pregnant women).
Patient pain will radiate down to the knee.
History of spinal surgery.
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Written informed consent will be taken. After enrollment into study, patient will be allocated either to group A or Group B by lottery method. No. of Chits will be equal to total sample size, odd Numbers will be allocated to Group A and even number will be allocated to Group B.Each patient will be requested to draw a chit from the box and after that patient will be recruited into either Group A or Group B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant, Assessor Blind: Data safety will be ensured by assigning
Specific Identity numbers and all consent, readings forms
will be placed in locker to blind Assessors
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Committee (REC), Riphah College of Rehabilitation Sciences,Lahore campus
Street address
28-M, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Postal code
54000
Approval date
2020-02-08, 1398/11/19
Ethics committee reference number
REC/RCRS/20/1034
Health conditions studied
1
Description of health condition studied
Chronic nonspecific low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain
Timepoint
First (pre/post) and third and sixth week
Method of measurement
Numeric Pain Rating Scale
2
Description
Range of motion for flexion and extension
Timepoint
First (pre/post) and third and sixth week
Method of measurement
Lumber inclinometer
Secondary outcomes
1
Description
Function
Timepoint
First (pre/post) and third and sixth week
Method of measurement
Modified Oswestry disability index
Intervention groups
1
Description
Intervention group:Lumber sustained natural appophyseal glide SNAG on Lumber L4/L5 vertebrae. The subjects will receive mulligan concept SNAG (sustained natural Appophyseal glide) position of subject: sitting on the edge of table and both feet will be support on footstep. The therapist must be standing behind the subject and place a belt around the subject’s lower abdomen (below the anterior superior illac spine) also the therapist below hips. The Ulnar border of therapist right hand will be placed under the spinous process of vertebra above the suspected spinal segment. The other hand will be placed on the bed to the left of subject. The mobilizing force will be parallel to the facet joint plan in cephalic direction and asked the subject to lean forward. Sustained the flexed position for few seconds and maintain the facet glide until the subject erect.
Category
Treatment - Other
2
Description
Intervention group:The subject will receive METS on Quadrates lumborum (post isometric relaxation technique) position of subject: side lying and the physiotherapist behind the subject at waist level. the subject will extend uppermost arm over the head to grasp the top end of the table and on inhalation subject will abduct his uppermost leg until the therapist palpates quadrates activity(elevated around 30◦).the subject is asked to hold the leg isometricaly in this state and allowing gravity to provide resistance. After 10 sec the subject let the leg to fall toward the floor.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Riphah Rehab Center, Lahore Pakistan
Full name of responsible person
Muhammad Hashim
Street address
393-D3 wapda Town Lahore
City
Lahore
Postal code
54770
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Street address
28-M Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
20
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Assra Noor Javed
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 3434557209
Email
assra.khan.ak@gmail.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