Protocol summary
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Study aim
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To evaluate the effects of core stability with dynamic stretching in addition to routine physical therapy in patients with chronic low back pain.
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Design
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Parallel, single blinded,randomized controlled trial
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Settings and conduct
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The study would be single blinded as the assessor was being masked. and will be done Govt. Mian Munshi Dhq teaching hospital Lahore
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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Pain, range of motion, physical disability
General information
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Reason for update
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errors in data need corrections
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Acronym
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Tanvir
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IRCT registration information
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IRCT registration number:
IRCT20210908052416N1
Registration date:
2021-09-21, 1400/06/30
Registration timing:
retrospective
Last update:
2021-09-29, 1400/07/07
Update count:
1
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Registration date
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2021-09-21, 1400/06/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-10-26, 1399/08/05
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Expected recruitment end date
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2021-04-26, 1400/02/06
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Actual recruitment start date
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2020-10-26, 1399/08/05
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Actual recruitment end date
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2021-04-26, 1400/02/06
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Trial completion date
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2021-04-26, 1400/02/06
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Scientific title
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Effects of core stability with dynamic stretching in addition to routine physical therapy in patients with chronic low back pain.
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Public title
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Effects of core stability with dynamic stretching in addition to routine physical therapy in patients with chronic low back pain.
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with the history of non-specific chronic low back pain, both male and female patients, age ranges from 20 to 50 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
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Age
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No age limit
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
48
Actual sample size reached:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants were allocated to either to group A or group B by lottery method. Researcher had taken paper chits equal in number to sample size and wrote numbers from 1 to 48 on each paper chit separately. The paper chits are folded, put in box and well shuffled the box. Each participant was requested to draw a paper chit from the box and give to the researcher. Odd numbers were allocated to group A and even numbers were allocated to group B .Participants were recruited into either group A or group B. Each group consists of 24 participants.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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This was a single blinded study as the assessor was 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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Parallel group, double blinded, randomized controlled trial
Ethics committees
1
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Ethics committee
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Approval date
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2020-06-04, 1399/03/15
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Ethics committee reference number
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IRB-Uol-Fahs
Health conditions studied
1
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Description of health condition studied
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Chronic low back pain
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ICD-10 code
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M54.5
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ICD-10 code description
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Low back pain
Primary outcomes
1
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Description
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Pain intensity
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Timepoint
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Before intervention and then on 2nd, 4th and 6th week
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Method of measurement
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Numeric pain rating scale
2
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Description
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Range of motion
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Timepoint
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Before intervention and then on 2nd, 4th and 6th week
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Method of measurement
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Universal goniometer
3
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Description
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Functional disability
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Timepoint
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Before intervention and then on 2nd, 4th and 6th week
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Method of measurement
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Oswetry Low Back Pain Disability Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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The university of Lahore
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Proportion provided by this source
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60
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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Afetr publication
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To whom data/document is available
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people working in academic institutions and researchers
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Under which criteria data/document could be used
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It could be used on request
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From where data/document is obtainable
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Through phone and Email drtanvirhussain212@@gmail.com
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What processes are involved for a request to access data/document
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Through Email and phone 00923024646625
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Comments
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data can bee provided on request but after publication