Protocol summary

Study aim
To compare the effects of Mc Gill versus Lee stabilization exercises on pain, disability, range of motion, quality of life and endurance in patient with chronic nonspecific low back pain
Design
The trial will be conducted at Sir Ganga Ram Hospital, Lahore.The participant will be blinded by the concealment of the technique that will be used on them.
Settings and conduct
Randomized clinical trial, single blinded study, two parallel groups with 32 patients from Sir Ganga Ram Hospital, Lahore.
Participants/Inclusion and exclusion criteria
Inclusion criteria Both male and female patient Age 30–50 years Patient with a history of 3 months nonspecific low back pain Pain intensity (3-7) according to NPRS score Exclusion Criteria Any lumbar surgery Spinal stenosis Neurological dysfunction Systemic disease Pregnancy
Intervention groups
Intervention group 1 :The Mc Gill group in the study will follow a six-week exercise regimen, where they will participate in sessions thrice a week week with 6-10 repetition : ⦁ Curl-Up, ⦁ Bird-Dog, ⦁ Side Plank Intervention group 2: The Lee Stabilization group in the study will follow a six-week exercise protocol specific to the Lee Stabilization method, attending sessions three times a week. The main exercises will be Upper-Body Extension,Alternate Arm and Leg Lift,Alternate Arm and Leg Extension on All Fours, Diagonal Curl Up and Curl up with arms at sides, tilt pelvis to flatten back.
Main outcome variables
Pain,disability, range of motion, quality of life and endurance

General information

Reason for update
Acronym
nlbp
IRCT registration information
IRCT registration number: IRCT20190717044238N14
Registration date: 2024-05-18, 1403/02/29
Registration timing: prospective

Last update: 2024-05-18, 1403/02/29
Update count: 0
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
Fareeha Amjad
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 99200600
Email address
fari_fairy22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-20, 1403/02/31
Expected recruitment end date
2024-07-29, 1403/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Mcgill versus Lee Stabilization Exercises on Pain, Disability, Range of motion, Quality of life and Endurance in Patient with Chronic Nonspecific Low Back Pain
Public title
Effects of Mcgill versus Lee Stabilization Exercises on Pain, Disability, Range of motion, Quality of life and Endurance in Patient with Chronic Nonspecific Low Back Pain
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with a history of 3 months nonspecific low back pain Pain intensity (3–7) according to NPRS score Age: 30–50 years Both male and female patients
Exclusion criteria:
Any lumbar surgery Spinal stenosis Neurological dysfunction Systemic disease Pregnancy Infections Carcinoma Any fracture or deformity
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by using sealed envelops which involves assigning participants to different groups by randomly selecting an envelope that contains their group assignment. This will ensure reduced bias in allocation of interventions. Simple randomization method is used to allocate participants to different groups
Blinding (investigator's opinion)
Single blinded
Blinding description
In the trial the participant( who are willing to participate) is blinded by not knowing or being unaware which intervention they are receiving , but the researcher (physiotherapist) know. This trial will be single blinded. Researcher will be responsible for care for participants during the trial, data collectors, outcome assessors, and with lessor importance Data Safety .
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research and ethics Commitee Riphah College of Rehabilitation and Allied Health Sciences
Street address
Riphah International University Gulberg campus lahore
City
Lahore
Postal code
54000
Approval date
2024-04-03, 1403/01/15
Ethics committee reference number
REC/RCR&AHS/23/0190

Health conditions studied

1

Description of health condition studied
chronic non specific low back pain
ICD-10 code
Low Back P
ICD-10 code description
M54.5

Primary outcomes

1

Description
Pain
Timepoint
Before intervention, 6 weeks
Method of measurement
Numeric pain rating scale (NPRS)

2

Description
Functional disability
Timepoint
Before intervention, 6 weeks
Method of measurement
Urdu version of Oswestry Disability index (ODI)

3

Description
Range of motion
Timepoint
Before intervention, 6 weeks
Method of measurement
Inclinometer

4

Description
Endurance
Timepoint
Before intervention, 6 weeks
Method of measurement
Sorensen Test

5

Description
quality of life
Timepoint
Before intervention, 6 weeks
Method of measurement
SF-36 Urdu version

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Mc Gill group
Category
Rehabilitation

2

Description
Control group: Lee Stabilization
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Sir Ganga Ram Hospital, Lahore
Full name of responsible person
Hafiza Sumbal Liaqat
Street address
Sir Ganga Ram Hospital, Lahore
City
Lahore
Postal code
54000
Phone
+92 332 0459833
Email
sumballiaqat10@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Fareeha Amjad
Street address
Riphah International University Lahore Gulberg green campus
City
Lahore
Postal code
54000
Phone
+92 334 3372779
Email
fari_fairy22@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Riphah International University Lahore
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Hafiza Sumbal Liaqat
Position
MS student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Lahore Gulberg green campus
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 332 0459833
Email
sumballiaqat10@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Fareeha Amjad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Lahore Gulberg green campus
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 334 3372779
Email
fari_fairy22@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Hafiza Sumbal Liaqat
Position
MS sudent
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Lahore Gulberg green campus
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 332 0459833
Email
sumballiaqat10@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
confidentiality of participants
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Consent form in its original format with no information about any participant study protocol -how the intervention was given to both groups
When the data will become available and for how long
Data would be available after the completion of the research
To whom data/document is available
People working in an academic and clinical setting can have access to the above mentioned information/documents
Under which criteria data/document could be used
Data can be used for research paper
From where data/document is obtainable
Data can be requested at following email: sumballiaqat10@gmail.com
What processes are involved for a request to access data/document
One can ask for data at the given email address and it would be provided after knowing the general implications of sharing that particular data
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