Protocol summary
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Study aim
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To determine the effects of Maitland mobilization and Mulligan medial/lateral glide
on pain intensity, knee ROM and functional performance in patients with knee
osteoarthritis.
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Design
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Two groups, parallel group, double blinded, Randomized Controlled Trial.
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Settings and conduct
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Riphah College of Rehabilitation & Allied Health Sciences
The way forward day care centre, Lahore
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Participants/Inclusion and exclusion criteria
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INCLUSION CRITERIA: Old adults ( age above 60 years) Male and female Patients who met the American College of Rheumatology clinical criteria for knee osteoarthritis Radiological evidence of knee OA grades 0 , 1 and 2 as per Kellgren Lawrence grading system Pain intensity of at least 3 on Visual Analogue Scale (VAS) Willing to participate in research project EXCLUSION CRITERIA: Infection or inflammatory disorder History of surgery or trauma on knee Malignancy Systemic illness Rheumatoid Arthritis Fracture, any situation which is contraindicate mobilization Osteoporosis Current use of any medication or physiotherapy treatment Cognitive impairments
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Intervention groups
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Group A: Maitland mobilization with conventional physical therapy
Group B: medial/lateral mulligan mobilization with conventional physical therapy
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Main outcome variables
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Pain, Range of motion (ROM), Functional disability
NPRS, Goniometer, Modified Western Ontario and McMaster Universities Arthritis Index ( WOMAC scale)
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200619047835N1
Registration date:
2020-08-24, 1399/06/03
Registration timing:
registered_while_recruiting
Last update:
2020-12-23, 1399/10/03
Update count:
1
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Registration date
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2020-08-24, 1399/06/03
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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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2020-04-01, 1399/01/13
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Expected recruitment end date
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2020-09-30, 1399/07/09
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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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"Effects of Maitland mobilization and mulligan medial/lateral glide mobilization in knee osteoarthritis."
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Public title
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"Effects of Maitland mobilization and mulligan medial/lateral glide mobilization in knee osteoarthritis."
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Middle & old adults (age above 60 years)
Male and female
Patients who met the American College of Rheumatology clinical criteria for knee osteoarthritis
Radiological evidence of knee OA grades 0, 1 and 2 as per Kellgren Lawrence grading system
Pain intensity of at least 3 on Visual Analogue Scale (VAS)
Willing to participate in research project
Exclusion criteria:
Infection or inflammatory disorder
History of surgery or trauma on knee
Malignancy
Systemic illness
Rheumatoid Arthritis
Fracture, any situation which is contraindicate mobilization
Osteoporosis
Current use of any medication or physiotherapy treatment
Cognitive impairments
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Age
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From 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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- Participant
- Outcome assessor
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Sample size
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Target sample size:
22
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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written conset form will be taken. after enrollment into study , patient will be allocated either group A or group B by lottery method. No. of chits will be equal to total sample size, odd numbers will be allocated to Group A and even number will be allocated to Group B. each patient will be requested to draw a chit from the box and after that patient will be recruited into either Group A or Group B
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Assessor Blind: Data safety will be ensured by assigning Specific Identity numbers and all consent, readings forms will be placed in locker to blind Assessors
Participant Blind : study participants are unaware of the group allocations in such a way equal time is given to each patient, session schedule for each patient is different. the patients does not know who is receiving which intervention.
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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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Ethics committees
1
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Ethics committee
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Approval date
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2020-02-08, 1398/11/19
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Ethics committee reference number
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REC/RCRS/20/1038
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
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ICD-10 code description
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Osteoarthritis of knee
Primary outcomes
1
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Description
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Pain
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Timepoint
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Before treatment, during treatment at 3rd week and after treatment at 6th week, Follow up in 9th week
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Method of measurement
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The Numeric Pain Rating Scale (NPRS)
Secondary outcomes
1
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Description
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Range of motion ROM
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Timepoint
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Before treatment, during treatment at 3rd week and after treatment at 6th week, follow up in 9th week
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Method of measurement
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Goniometer
2
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Description
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Functional disability
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Timepoint
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Before treatment, during treatment at 3rd week and after treatment at 6th week, follow up in 9th week
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Method of measurement
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Modified Western Ontario and McMasterUniversities Arthritis Index( WOMAC scale)
Intervention groups
1
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Description
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Intervention group A: Maitland mobilization with conventional physical therapy
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Category
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Other
2
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Description
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Intervention group B: medial/lateral mulligan mobilization with conventional physicaltherapy
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Category
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Other
1
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Sponsor
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Grant name
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Educational
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Grant code / Reference number
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1033
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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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Riphah International University
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Proportion provided by this source
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15
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Public or private sector
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Public
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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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Sponsor: country of origin
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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