Protocol summary
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Study aim
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The study aims to Compare the effects of the Active Release Technique and Muscle Energy Technique On Low Back Pain, Range of Motion, and Balance caused by psoas syndrome among office workers.
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Design
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A single-blinded randomized controlled trial, conducted on 80 patients, equally divided into two groups, single centered study
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Settings and conduct
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Family clinic in Lahore. single-blinded study (patient will be blinded to the recruited group)
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: both gender; age 25-53 years, Low Back Pain for more than 3 months.
Exclusion criteria: history of trauma; systemic diseases; fractures; congenital diseases; dislocation.
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Intervention groups
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Patients with low back pain caused by psoas muscle will be selected from both genders. VAS will be used to measure low back pain. Goniometer will be used to measure the range of motion, and a berg balance scale will be used to measure balance.
Group A: will receive routine physical therapy for low back pain i.e; hot packs, tens therapeutic ultrasonic, with spine isometrics, rolling technique, along with active release technique. Each session would be of 40-45 minutes 5 times a week for 3 weeks to 6 weeks.
Group B: will receive routine physical therapy for low back pain i.e; hot packs, tens therapeutic ultrasonic, with spine isometrics, rolling technique, along with muscle energy technique. Each session would be of 40-45 minutes 5 times a week for 3 weeks to 6 weeks.
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Main outcome variables
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1. Pain intensity 2. Range of motion 3. Berg balance scale
General information
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Reason for update
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to update actual recruitment dates
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Acronym
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RCT
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IRCT registration information
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IRCT registration number:
IRCT20190717044238N2
Registration date:
2023-01-15, 1401/10/25
Registration timing:
registered_while_recruiting
Last update:
2023-03-19, 1401/12/28
Update count:
1
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Registration date
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2023-01-15, 1401/10/25
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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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2023-01-05, 1401/10/15
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Expected recruitment end date
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2023-01-30, 1401/11/10
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Actual recruitment start date
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2023-01-05, 1401/10/15
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Actual recruitment end date
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2023-02-10, 1401/11/21
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Trial completion date
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2023-02-10, 1401/11/21
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Scientific title
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Comparison of active release technique and muscle energy technique on low back pain, range of motion, and balance in patients with psoas syndrome among office workers
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Public title
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physiotherapy of low back pain due to psoas syndrome in office workers
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Both gender
Age 25-53 years old
Low Back Pain for more than 3 months
Exclusion criteria:
History of Trauma
Systemic diseases
Fractures
Congenital diseases
Dislocation
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Age
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From 25 years old to 53 years old
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Gender
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Both
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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:
80
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be randomly assigned into two groups using a computer-generated random number table. All those random numbers will be enclosed in sealed envelopes. A third person (who will further not be part of the research) will open envelopes and the patients will be allocated to the mentioned group accordingly.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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An independent assessor, who will be a senior and experienced physiotherapist and will not be part of the study, will assess patients.
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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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no
Ethics committees
1
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Ethics committee
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Approval date
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2022-06-13, 1401/03/23
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Ethics committee reference number
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REC-UOL-146-06/2022
Health conditions studied
1
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Description of health condition studied
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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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will be measure on baseline, week 3 and week 6.
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Method of measurement
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visual analogue scale
2
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Description
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range of motion
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Timepoint
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will be measure on baseline, week 3 and week 6.
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Method of measurement
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goniometer will be used.
Secondary outcomes
1
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Description
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balance
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Timepoint
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will be measure on baseline, week 3 and week 6.
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Method of measurement
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a berg balance scale will be used.
Intervention groups
1
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Description
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Intervention group: 1 will receive routine physical therapy for low back pain i.e; hot packs, tens therapeutic ultrasonic, with spine isometrics, rolling technique, along with active release technique. Each session would be of 40-45 minutes 5 times a week for 3 weeks to 6 weeks.
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Category
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Treatment - Other
2
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Description
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Intervention group: 2 will receive routine physical therapy for low back pain i.e; hot packs, tens therapeutic ultrasonic, with spine isometrics, rolling technique, along with muscle energy technique. Each session would be of 40-45 minutes 5 times a week for 3 weeks to 6 weeks.
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Category
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Treatment - Other
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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Yes
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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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1
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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available