Protocol summary
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Study aim
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The purpose of the present study to evaluate the synergistic effects of Mulligan Traction Straight Leg Raise Stretch and proprioceptive exercises in knee OA patients and effect of exercises to relive pain, stiffness and improve range of motion and functional ability of patients suffering from knee OA.
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Design
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The randomized clinical trial, double-blinded study use to investigate the effect of propioceptive and mulligan exercises in knee osteoarthritis.
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Settings and conduct
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Conduct at Muhammad physical therapy clinic and rehabilitation centre, Multan, Pakistan.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 1) Age 40-65 years
2) Patients with diagnosed OA
3) Both genders
4) Patients with swelling in knee joints
5) Patients with pain in knee joints
6) Patients having difficulty in walking and climbing stairs
Exclusion criteria: 1) Vascular neoplasia
2) Fibromyalgia
4) Radiculopathy
5) Neuropathy
6) Tumor
7) Joint fractures
8) Vestibular problems
9) Congenital disorders
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Intervention groups
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Group A will receive proprioceptive exercises, half squats, standing on just one foot, walking on the heel and toes, one-legged balance exercises and knee flexion and extension exercises while sat in a chair. Proprioceptive Exercise will be given 3 sessions/week for 8 weeks, with a total of 24 sessions, each lasting 45 minutes. Every exercise will be done for 1 to 2 minutes, with a 30-second break in between. Participants in the Mulligan Traction Straight Leg Raise Stretch group B will be the intervention 3 times a week for 30 minutes each session. Every session was involved performing 3 sets of 10 repetitions of straight leg lifts while using manual traction. Whereas Group C will be given both proprioceptive and MT-SLR.
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Main outcome variables
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Increase in ROM and functional ability, decrease in pain and inflammatory load in body.
General information
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Reason for update
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Some changes have been made
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230202057310N2
Registration date:
2023-08-29, 1402/06/07
Registration timing:
prospective
Last update:
2024-09-25, 1403/07/04
Update count:
3
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Registration date
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2023-08-29, 1402/06/07
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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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2023-08-31, 1402/06/09
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Expected recruitment end date
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2024-03-02, 1402/12/12
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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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Therapeutic utility of Mulligan traction straight leg raise stretch and proprioceptive exercise in treating osteoarthritis
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Public title
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Mulligan traction straight leg raise stretch and proprioceptive exercise in treating osteoarthritis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 40-65 years
Patients with diagnosed OA
Both genders
Patients with swelling in knee joints
Patients with pain in knee joints
Difficulty in walking and climbing stairs
Exclusion criteria:
Vascular neoplasia
Fibromyalgia
Radiculopathy
Neuropathy
Joint fractures
Vestibular problems
Congenital disorders
Tumor
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Age
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From 40 years old to 65 years old
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Gender
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Both
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Phase
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1
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
130
More than 1 sample in each individual
Number of samples in each individual:
2
Samples will be taken before and after treatment
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Allocation concealment occurs and patients will be recruited by using simple randomization through the Lottery method. lottery method carried out through sealed envelopes. Also the data analyser will be kept blind to minimize biasness
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants will be blinded. Participants will be unaware of the type of treatments that will be evaluated after the completion of the intervention trial. Subjects will be completely unaware of the type and effects of both interventions. And in the same way data analyser will be kept blind by not knowing about the effects and group details
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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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Patients were assessed by radiological finding (x-ray) and by physical assessment and by monitoring of biochemical parameters
Ethics committees
1
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Ethics committee
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Approval date
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2023-07-30, 1402/05/08
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Ethics committee reference number
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MIMAS/06/26/Maliha
Health conditions studied
1
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Description of health condition studied
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Knee osteoarthritis with grade 1,2 and 3
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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 and functional disability
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Timepoint
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8 weeks
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Method of measurement
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Numerical Pain Rating Scale, Pain catastrophizing scale, The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
2
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Description
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Range of motion
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Timepoint
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8 weeks
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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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Inflammatory biomarkers
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Timepoint
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8 weeks
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Method of measurement
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Complete blood count (CBC) and interleukins measurement
Intervention groups
1
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Description
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Intervention group: Group A will receive proprioceptive exercises, half squats, standing on just one foot, walking on the heel and toes (with eyes open and closed), one-legged balance exercises using a heating pad, and knee flexion and extension exercises while sat in a chair. Proprioceptive Exercise group A will be given 3 sessions/week for 8 weeks, with a total of 24 sessions, each lasting 45 minutes. The exercises in their program will develop from static to dynamic, including single-leg stances and balance exercises on unstable surfaces, starting with low-to-moderate intensity balance and stability exercises. Every exercise will be done for 1 to 2 minutes, with a 30-second break in between.
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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 The total treatment regimen will be 8 weeks, including 24 sessions, participants in the Mulligan Traction Straight Leg Raise Stretch (MT-SLR) group B get the intervention 3 times a week for 30 minutes each session. Every session will involve performing 3 sets of 10 repetitions of straight leg lifts while using manual traction. The traction force will be adjusted according to each individual's comfort level and the repetitions were held for 15–20 seconds each.
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Category
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Treatment - Other
3
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Description
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Intervention group: Group C will be given both proprioceptive and MT-SLR The total treatment regimen will be 8 weeks, including 24 sessions, participants in the Mulligan Traction Straight Leg Raise Stretch (MT-SLR) get the intervention 3 times a week for 30 minutes each session. Proprioceptive Exercise group will be given in 3 sessions/week for 8 weeks, with a total of 24 sessions, each lasting 45 minutes.
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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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Student fund
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Grant code / Reference number
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08/26/2023/MNSUAM
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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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Muhammad Nawaz Sharif University of Agriculture
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Proportion provided by this source
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70
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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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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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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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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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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
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Title and more details about the data/document
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The title is COMPARATIVE ANALYSIS OF MULLIGAN AND PROPRICEPTIVE EXERCISES IN KNEE OSTEOARTHRITIS.
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When the data will become available and for how long
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N/A
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To whom data/document is available
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N/A
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Under which criteria data/document could be used
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N/A
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From where data/document is obtainable
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N/A
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What processes are involved for a request to access data/document
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N/A
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Comments
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N/A