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CTRI Number  CTRI/2024/07/070138 [Registered on: 07/07/2024] Trial Registered Prospectively
Last Modified On: 27/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To check the Effect of Manual therapy(Mulligan) in female patient with Knee Osteoarthritis 
Scientific Title of Study   Effect of Mulligan Technique with Retro Walking on Functional Disability Quadriceps muscle strength and Quality of Life in Women with Knee Osteoarthritis A Randomized controlled trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neha Upadhyay 
Designation  Research Scholar  
Affiliation  Manav Rachna International Institute of Research and Studies  
Address  Manav Rachna International Institute of Research and Studies,physiotherapy department division -Q block room no QF08 Faridabad Manav Rachna campus road,sector 43

Faridabad
HARYANA
121004
India 
Phone  9870226339  
Fax    
Email  nehaupadhyay236@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pooja Sharma  
Designation  Associate Professor  
Affiliation  Manav Rachna International Institute of Research and Studies 
Address  Manav Rachna International Institute of Research and Studies, physiotherapy department division -Q block room no QF 08 Faridabad Manav Rachna campus road,sector 43

Faridabad
HARYANA
121004
India 
Phone  9999826604  
Fax    
Email  pooja.fas@mriu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Pooja Sharma  
Designation  Associate Professor  
Affiliation  Manav Rachna International Institute of Research and Studies 
Address  Manav Rachna International Institute of Research and Studies, physiotherapy department division -Q block room no QF 08 Faridabad Manav Rachna campus road,sector 43

Faridabad
HARYANA
121004
India 
Phone  9999826604  
Fax    
Email  pooja.fas@mriu.edu.in  
 
Source of Monetary or Material Support  
Manav Rachna International Institute of Research and Studies Manav Rachna Campus Rd Gadakhor Basti Village Sector 43 Faridabad Haryana Pincode 121004 
 
Primary Sponsor  
Name  none 
Address  none 
Type of Sponsor  Other [none ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pooja Sharma   Manav Rachna International Institute of Research and Studies   Manav Rachna International Institute of Research and Studies Manav Rachna Campus Rd Gadakhor Basti Village Sector 43 Pincode 121004
Faridabad
HARYANA 		 9999826604

pooja.fas@mriu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee, SAHS , MRIIRS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional treatment   the control group will undergo standard treatment for knee osteoarthritis with selective exercise and a hot pack for 10 minutes. Assessment taken baseline and at 6 week after intervention  
Intervention  mulligan mobilization with movement with retro walking  conventional treatment with mulligan mobilization with movement with retro walking. Treatment will be given 3 times/week for 6 weeks. baseline and at 6 weeks after intervention values recorded  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1 Subjects with unilateral knee osteoarthritis
2 Subjects have had knee osteoarthritis for more
than 6 months.
3 Subjects aged between 40-60years
4 Only females will be included in this study.
5 Subjects having Grade 2 according to Kellgren-Lawrence Classification.

 
 
ExclusionCriteria 
Details  1 Subjects have undergone lower limb surgery in
the past 6 months.
2 Subjects taking medication (NSAIDS and steroids)
3 Subjects with traumatic injury at the knee
joint, any neurologic condition affecting lower
extremity function in the past 6 years
4 Knee deformities
5 Recent knee fracture in the past 6 months
6 Subject inability to understand Hindi or English
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.WOMAC Questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index)
2.One repetition maximum
3.WHOQOL Questionnaire (Abbreviated WHO quality of life scale (WHOQOL-Brief)
 		 1 Baseline
2 Post-intervention after 6 week
 
 
Secondary Outcome  
Outcome  TimePoints 
1.App-based goniometer (DrGoniometers, CDM S.r.L)

2.NPRS (Numerical Pain Rating Scale )

 		 1. baseline
2. Post-intervention (after 6 weeks) 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

34subjects with the age group of 40-60, who are willing to participate, will be explained the purpose as well as the procedure of the study. they will be given an informed consent form explaining their rights as research subjects. They will evaluated for the inclusion and exclusion criteria and divided into two groups –Group A ( conventional treatment )and Group B(conventional treatment with mulligan mobilization with movement with retro walking). Subjects will be assessed for baseline measurements and their progression will be measured after the intervention of 6 weeks based On: WHOQOL for quality of life, One Repetition maximum for quadriceps muscle strength, WOMAC for functional disability, App-based goniometer (DrGoniometers, CDM S.r.L) for ROM, Numerical Pain Rating scale (NPRS) for pain. Hot pack for both groups for 10 minutes. 

 
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