Protocol summary
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Study aim
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To evaluate and compare the effects of muscle energy techniques (post isometric relaxation and reciprocal inhibition) to improve hamstring flexibility, anterior pelvic tilt, functional status and pain with knee osteoarthritis
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Design
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Single Blinded
Randomized Clinical Trial
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Settings and conduct
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District Head Quarter (DHQ) hospital
Allied hospital
Madinah teaching hospital
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age : 45-60 years old
Gender: Both
Pain : mild to moderate
osteoarthritis: grade II and III
Womac (The Western Ontario and McMaster Universities Arthritis Index) scoring: 65-75
Active knee extension test: 15-20 degree.
Exclusion criteria:
Patients with low back issue
Patients with previous history of infection, trauma, implant and surgery of affected limb
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Intervention groups
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Group A ( Post isometric relaxation)
Group B ( Reciprocal Inhibition)
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Main outcome variables
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Hamstring flexibility - Anterior pelvic tilt - Functional status - Pain
General information
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Reason for update
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want to update actual start date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230615058490N1
Registration date:
2023-06-24, 1402/04/03
Registration timing:
prospective
Last update:
2023-11-25, 1402/09/04
Update count:
1
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Registration date
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2023-06-24, 1402/04/03
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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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2023-06-25, 1402/04/04
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Expected recruitment end date
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2023-08-23, 1402/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the effects of muscle energy techniques (post isometric relaxation and reciprocal inhibition) on hamstring tightness and anterior pelvic tilt with knee osteoarthritis: A randomized clinical trial
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Public title
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Effects of muscle energy techniques (post isometric relaxation and reciprocal inhibition) in knee osteoarthritis
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age : 45-60 years old
Gender: Both
Grade of knee Osteoarthritis: II and III (kellgren and Lawrence system of Classification)
Pain level : mild to moderate on Visual analogue scale
Active Knee extension test : 15-20 degree
Anterior pelvic tilt: increase
Chronic pain : 1-2 years
Side : unilateral
The Western Ontario and McMaster Universities Arthritis Index ( WOMAC) scoring : 67-75
Exclusion criteria:
Patients with any Low back issue
Patients with recent history of injury of Hamstring
Patients with history of fracture,surgery or implant of affected limb
Patients with neurological disorder
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Age
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From 45 years old to 60 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:
32
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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32 participants will be divided into 2 treatment groups A and B on the basis of lottery method randomization after division into 2 groups. Group A will receive Post isometric relaxation and other group will receive Reciprocal inhibition
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Participants will be divided into two groups according to lottery method randomization. Group A and Group B will be mentioned on slips, participants will chose the slip according to which they will be divided, participants will not know will treatment precools they will receive.
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-03-03, 1401/12/12
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Ethics committee reference number
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TUF/IRB/176/2023
Health conditions studied
1
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Description of health condition studied
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Knee osteoarthritis
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ICD-10 code
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M17.9
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ICD-10 code description
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Arthropathies
Primary outcomes
1
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Description
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Hamstring flexibility
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Timepoint
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Will be assessed before start of 1st session, after 6th session and after 12th session
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Method of measurement
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Active knee extension test
2
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Description
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Anterior pelvic tilt
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Timepoint
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Will be assessed before start of 1st session, after 6th session and after 12th session
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Method of measurement
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Calliper based inclinometer
3
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Description
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Functional status
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Timepoint
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Will be assessed before start of 1st session, after 6th session and after 12th session
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Method of measurement
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The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Secondary outcomes
1
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Description
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Pain
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Timepoint
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Will be assessed before start of 1st session, after 6th session and after 12th session
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Method of measurement
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Visual analogue scale
Intervention groups
1
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Description
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Intervention group: Group A will receive Post Isometric relaxation 3 sessions per week for 4 weeks
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Category
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Treatment - Other
2
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Description
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Intervention group: Group B will receive Reciprocal Inhibition 3 sessions per week for 4 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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No
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Title of funding source
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all financial expenses will be born by myself
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Proportion provided by this source
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100
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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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Other
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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No - There is not 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