The study would be double blinded as the assessor and participant being masked. and will be done Govt. Mian Munshi Dhq teaching hospital Lahore
Participants/Inclusion and exclusion criteria
Inclusion criteria:
•Patient with history of chronic non specific Low Back Pain Either gender ,age ranges from 20-50 years 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 ,Fracture
Intervention groups
Intervention groups
1
Description
Intervention group: Patients in Group B were treated with core stability exercises (squats, crunches, front plank, plank with alternating leg lift, supine 2 leg bridge exercise), dynamic stretching (Slum stretch, cat and camel stretch, child pose stretch, overhead lateral stretch, and side leg swings), and routine physical therapy (Experimental Group). For six weeks, both groups received two sessions per week. All of the exercises are performed in two sets of 10-15 repetitions during each session.
Category
Rehabilitation
2
Description
Patients in Group-A (Control Group) receive RPT, which involves 20 minutes of hot pack superficial moist heat and 20 minutes of traditional transcutaneous electrical nerve stimulation (TENS) to the pain site utilising a dual-channel portable TENS unit with an 80-100 pulses per second frequency. In addition, abdominal curl ups in supine, back extensor exercises in prone, hip extensor exercises in prone, and lumber rotation are performed.
Category
Rehabilitation
Main outcome variables
Pain, range of motion, physical disability
General information
Reason for update
Acronym
Tanvir
IRCT registration information
IRCT registration number:IRCT20210908052416N1
Registration date:2021-09-21, 1400/06/30
Registration timing:prospective
Last update:2021-09-21, 1400/06/30
Update count:1
Registration date
2021-09-21, 1400/06/30
Registrant information
Name
Tanvir Hussain
Name of organization / entity
University of lahore
Country
Pakistan
Phone
+92 41 6116226
Email address
drtanvirhussain212@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-27, 1400/07/05
Expected recruitment end date
2022-03-27, 1401/01/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of core stability with dynamic stretching in addition to routine physical therapy in patients with chronic low back pain.
Public title
Effects of core stability with dynamic stretching in addition to routine physical therapy in patients with chronic low back pain.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with the history of non-specific chronic low back pain, both male and female patients, age ranges from 18 to 70 years will include in the 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,fracture
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
A randomized blocks method with a block size of 4 and a ratio of 1:1 was used to assign eligible people to experimental and control groups. To conceal allocations, randomization codes were kept in sealed opaque envelopes numbered sequentially and maintained until the interventions were assigned to the study participants .
Blinding (investigator's opinion)
Double blinded
Blinding description
This was a double blinded study as the assessor and participants were not disclosed about the study group .Assessor was another physical therapist who measured the pre-trial and post-trial readings of pain, range of motion and physical disability. The data collected by the assessor was provided to the researcher.
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
2020-09-21, 1399/06/31
Ethics committee reference number
IRB-Uol-Fahs
Health conditions studied
1
Description of health condition studied
Chronic 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 2nd, 4th and 6th week
Method of measurement
Numeric pain rating scale
2
Description
Range of motion
Timepoint
Before intervention and then on 2nd, 4th and 6th week
Method of measurement
Universal goniometer
3
Description
Functional disability
Timepoint
Before intervention and then on 2nd, 4th and 6th week
Method of measurement
Oswetry Low Back Pain Disability Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Patients in intervention group were treated with core stability exercises (squats, crunches, front plank, plank with alternating leg lift, supine 2 leg bridge exercise), dynamic stretching (Slum stretch, cat and camel stretch, child pose stretch, overhead lateral stretch, and side leg swings), and routine physical therapy (Experimental Group). For six weeks, both groups received two sessions per week. All of the exercises are performed in two sets of 10-15 repetitions during each session.
Category
Rehabilitation
2
Description
Control group: Patients in Group-A (Control Group) receive Routine physical therapy, which involves 20 minutes of hot pack superficial moist heat and 20 minutes of traditional transcutaneous electrical nerve stimulation (TENS) to the pain site utilising a dual-channel portable TENS unit with an 80-100 pulses per second frequency. In addition, abdominal curl ups in supine, back extensor exercises in prone, hip extensor exercises in prone andlumber rotation
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Govt.Mian Munshi Dhq teaching hospital Lahore
Full name of responsible person
Dr.Muhammad Yousaf
Street address
Sagian wala bypass, Data Gunj Baksh town
City
lahore
Postal code
54000
Phone
+92 42 37147265
Email
hamzachemist24pk@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of lahore
Full name of responsible person
Dr.Fareeha Amjad
Street address
1-Km Defence Road، Near Bhuptian Chowk، Lahore
City
lahore
Postal code
54000
Phone
+92 42 37812194
Email
fari_fairi@yahoo.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
Govt.Mian Munshi Dhq teaching hospital lahore
Full name of responsible person
Tanvir hussain
Position
physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Sagian Wala Bypass, Data Gunj Buksh Town, Lahore
City
lahore
Province
punjab
Postal code
54000
Phone
+92 42 37147265
Email
drtanvirhussain212@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Govt.Mian Munshi Dhq teaching hospital Lahore
Full name of responsible person
Tanvir hussain
Position
physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Sagian Wala Bypass, Data Gunj Buksh Town, Lahore,
City
lahore
Province
punjab
Postal code
54000
Phone
+92 42 37147265
Email
drtanvirhussain212@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Govt.Mian Munshi Dhq teaching hospital Lahore
Full name of responsible person
Tanvir hussain
Position
punjab
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Sagian Wala Bypass, Data Gunj Buksh Town, Lahore,
City
Lahore
Province
punjab
Postal code
54000
Phone
+92 42 37147265
Email
drtanvirhussain212@gmail.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
EFFECTS OF CORE STABILITY WITH DYNAMIC STRETCHING IN ADDITION TO ROUTINE PHYSICAL THERAPY IN PATIENTS WITH CHRONIC LOW BACK PAIN and all collected deidentified IPD will be shared.
When the data will become available and for how long
Afetr 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 phone and Email drtanvirhussain212@@gmail.com
What processes are involved for a request to access data/document
Through Email and phone 00923024646625
Comments
data can bee provided on request but after publication