Protocol summary
-
Study aim
-
To evaluate the comparative effects of mulligan traction straight leg raise versus muscle energy technique on pain intensity and hamstring tightness in patient with knee osteoarthritis
-
Design
-
The study will be based on research design of randomized clinical trial. Single blind study, in which patient will be blind, patient with osteoarthritis grade1,2 will be included in this study, randomization being accomplished using simple random sampling by means of lottery method.
-
Settings and conduct
-
Re+active Rehabilitation Center. The participant are kept anonymous for conducting single-blind trail.
-
Participants/Inclusion and exclusion criteria
-
Both male and female Patients diagnosed with knee osteoarthritis grade 1 and grade 2, with the radiographic evidence as Kellgren-Lawrence criteria of knee osteoarthritis, Age between 40 to 65years, Subject shows more than mild pain on VAS, Patient more than mild disability in OKS, Unilateral involvement, participant can walk without any assistive device e.g. crutches or walk helplessly, Patients who will willing to participate, At least can climb and incline the flight of stairs, Patient who quit all pain killers and muscle relaxant medication will be included while pregnant women, participant with diagnosed musculoskeletal disorders related to knee joint e.g. femoral-patellar syndrome, patients with surgical history of lower limbs/spine, patients with pathologies or any deformity of hip joint/spine, patient with neurological disorder for example Alzheimer’s disease, fracture will be excluded.
-
Intervention groups
-
Both groups will receive moist hot pack and TENS as a baseline treatment. Group A: after baseline treatment mulligan traction straight leg raise technique will be applied on effected leg. Group B: after baseline treatment muscle energy technique will be applied on effected leg.
-
Main outcome variables
-
Hamstring tightness, knee pain
General information
-
Reason for update
-
Because I have to update the recruitment dates.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20210815052194N1
Registration date:
2021-08-29, 1400/06/07
Registration timing:
prospective
Last update:
2021-10-22, 1400/07/30
Update count:
1
-
Registration date
-
2021-08-29, 1400/06/07
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2021-08-30, 1400/06/08
-
Expected recruitment end date
-
2021-09-10, 1400/06/19
-
Actual recruitment start date
-
2021-09-01, 1400/06/10
-
Actual recruitment end date
-
2021-09-11, 1400/06/20
-
Trial completion date
-
2021-10-14, 1400/07/22
-
Scientific title
-
Comparative Effects of Mulligan Traction Straight Leg Raise Versus Muscle Energy Technique on Pain Intensity and Hamstring Tightness in patient With Knee Osteoarthritis
-
Public title
-
Effect of stretching in patient with knee osteoarthritis
-
Purpose
-
Health service research
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Both male and female Patients diagnosed with knee osteoarthritis grade 1 and grade 2, with the radiographic evidence as Kellgren-Lawrence criteria of knee osteoarthritis.
Age between 40 to 65years.
Subject shows more than mild pain on VAS.
Patient more than mild disability in OKS.
Unilateral involvement.
Can walk without any assistive device e.g. crutches or walk helplessly.
Patients who was willing to participate.
At least can climb and incline the flight of stairs.
Patient who quit all pain killers and muscle relaxant medication.
Exclusion criteria:
Pregnancy.
Participant with diagnosed musculoskeletal disorders related to knee joint e.g. femoral-patellar syndrome.
Patients with surgical history of lower limbs/spine.
Patients with pathologies or any deformity of hip joint/spine.
Patient with neurological disorder for example Alzheimer’s disease.
Participants who were refusing to consent.
Participants having unhealed fracture
-
Age
-
From 45 years old to 65 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
36
Actual sample size reached:
36
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
The randomization of the participants will be done by using the simple random sampling also called lottery method. Firstly each member of the population is assigned a number. In the next step these numbers are written on separate cards which are physically similar in shape, size, color etc. Then they are placed in a basket and thoroughly mixed. In the last step the slips are taken out randomly without looking at them. The number of slips drawn will be equal to the sample size.
-
Blinding (investigator's opinion)
-
Single blinded
-
Blinding description
-
Both group Participants will not be aware of the study groups and this will be carried out by keeping the participants anonymous for the study period
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2021-05-25, 1400/03/04
-
Ethics committee reference number
-
TUF/DR/SA/MSPP/2021/237-246
Health conditions studied
1
-
Description of health condition studied
-
knee osteoarthritis
-
ICD-10 code
-
M17
-
ICD-10 code description
-
Osteoarthritis of knee
Primary outcomes
1
-
Description
-
knee pain intensity
-
Timepoint
-
Before intervention, 2 weeks and 4 weeks after intervention
-
Method of measurement
-
Visual analogue scale will be used to measure the knee pain intensity.
2
-
Description
-
Hamstring tightness
-
Timepoint
-
Before intervention, 2 weeks and 4 weeks after intervention
-
Method of measurement
-
Goniometer during active knee extension test will used to assess reduction in hamstring tightness.
Secondary outcomes
1
-
Description
-
Oxford knee score questionnaire for disability
-
Timepoint
-
before intervention and 4th week
-
Method of measurement
-
Oxford knee score will be used for the assessment patients disability
Intervention groups
1
-
Description
-
Intervention group: Group A (Mulligan traction straight leg raise) treatment will be given to participant's for 4 week, baseline treatment will be moist hot pack and Tens for 10 minutes and than mulligan traction straight leg raise will be applied.
-
Category
-
Treatment - Other
2
-
Description
-
Intervention group: Group B (Muscle energy technique) treatment will be given to participant's for 4 week, baseline treatment will be moist hot pack and Tens for 10 minutes and than muscle energy technique will be applied, 2 sets of 10 repetitions per session. By using 20% of their total strength with hold of 5 second participants will perform isometric contraction and rest for 3-5 seconds between each isometric contraction
-
Category
-
Treatment - Other
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Pro Health Rehab and Medical Center
-
Proportion provided by this source
-
100
-
Public or private sector
-
Private
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Other
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
As we have signed and assured the patient that there data will not be share any where else other than current study
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Yes - There is a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable
-
Title and more details about the data/document
-
The primary and secondary outcome measure data will be shared and no further detail regarding patients personal information will be provided,
-
When the data will become available and for how long
-
Starting in January 2022
-
To whom data/document is available
-
For everyone
-
Under which criteria data/document could be used
-
Whoever will request for data
-
From where data/document is obtainable
-
Through Email address
-
What processes are involved for a request to access data/document
-
an Email
-
Comments
-