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CTRI Number  CTRI/2024/05/066730 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of effects of two physiotherapy mobilization interventions as an adjunct to institution-based exercise program on pain, joint motion, strength, ability to perform activities of daily living & quality of life in knee osteoarthritis patients  
Scientific Title of Study   Effects of mobilization with movement vs Maitland joint mobilization as an adjunct to institution-based exercise program on pain, ROM, strength, functional status & quality of life in knee osteoarthritis patients: A randomised clinical 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  Vedangi Sudhir Trikande  
Designation  Postgraduate resident  
Affiliation  Sancheti Institute for orthopaedics and Rehabilitation College of Physiotherapy 
Address  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Musculoskeletal Physiotherapy Department, 11/12, Thube Park, Shivaji Nagar, Pune

Pune
MAHARASHTRA
411005
India 
Phone  9370765908  
Fax    
Email  vtrikande@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Venu Mohan D 
Designation  Associate professor 
Affiliation  Sancheti Institute for orthopaedics and Rehabilitation College of Physiotherapy 
Address  Sancheti Institute for orthopaedics and Rehabilitation College of Physiotherapy, Musculoskeletal Physiotherapy Department, 11/12, Thube Park, Shivajinagar, Pune

Pune
MAHARASHTRA
411005
India 
Phone  9440690707  
Fax    
Email  venumohan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Venu Mohan D 
Designation  Associate professor 
Affiliation  Sancheti Institute for orthopaedics and Rehabilitation College of Physiotherapy 
Address  Sancheti Institute for orthopaedics and Rehabilitation College of Physiotherapy, Musculoskeletal Physiotherapy Department, 11/12, Thube Park, Shivajinagar, Pune

Pune
MAHARASHTRA
411005
India 
Phone  9440690707  
Fax    
Email  venumohan@gmail.com  
 
Source of Monetary or Material Support  
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy  
 
Primary Sponsor  
Name  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy  
Address  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12, Thube Park, Shivaji Nagar, Pune 411005 
Type of Sponsor  Private medical college 
 
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 
Vedangi Sudhir Trikande  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy   Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Musculoskeletal Physiotherapy Department, 11/12, Thube Park, Shivaji Nagar, Pune 411005
Pune
MAHARASHTRA 		 9370765908

vtrikande@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Maitland joint mobilization and institution-based exercise program  The experimental group B will receive the Maitland joint mobilization for knee joint and institution-based exercise program which is integrated set of strengthening exercises, stretching exercises, balance exercises, and aerobic exercises. This program will be performed for 3 days a week for 4 weeks. 
Intervention  mobilization with movement and institution-based exercise program  The experimental group A will receive the mobilization with movement for knee joint and institution-based exercise program which is integrated set of strengthening exercises, stretching exercises, balance exercises, and aerobic exercises. This program will be performed for 3 days a week for 4 weeks. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Subjects of either gender with an age group of 40-75yrs & having knee pain.
2.Subjects fulfilling American College of Rheumatology clinical criteria. At least one of the following three Age more than 50, morning stiffness less than 30 min,
Crepitus on knee motion, with or without X Ray findings.
3.Subjects with grade I to III knee osteoarthritis on the Kellgren and Lawrence
scale.
4.Subjects able to stand and walk without help. 
 
ExclusionCriteria 
Details  1.Subjects with history of knee/ lower limb joint replacement surgery.
2.Subjects present with history of any lower limb fracture or ligament injury.
3.Subjects with post-traumatic knee osteoarthritis.
4.Subjects with patellofemoral arthritis. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.VAS (Pain)
2.Universal goniometer 		 At baseline (0 weeks) and
Post-intervention (4 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
Time up and go  At baseline (0 weeks) and
Post-intervention (4 weeks) 
30s chair stand test  At baseline (0 weeks) and
Post-intervention (4 weeks) 
WOMAC CRD Pune  At baseline (0 weeks) and
Post-intervention (4 weeks) 
Micro FET3  At baseline (0 weeks) and
Post-intervention (4 weeks) 
WHOQOL-BREF  At baseline (0 weeks) and
Post-intervention (4 weeks) 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) 25/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 25/07/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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   Knee osteoarthritis is an articular degenerative disease. It is a complex joint condition that affects the entire joint, including bone, cartilage, synovium, ligaments and joint capsule. Symptoms of knee osteoarthritis include pain, joint stiffness, muscular weakness, poor proprioception and limited joint motion affecting daily life activities. The management of knee osteoarthritis aims to control pain, while improving physical function and quality of life. The OARSI, ACR and EULAR clinical practice guidelines promote an active lifestyle in osteoarthritis patients and states that exercise program aimed at improving cardiopulmonary fitness, muscular strength, flexibility and neuromuscular performance should be integrated into therapeutic management. Manual therapy has been used as a part of multimodal rehabilitation management for knee osteoarthritis because of its ability to relieve symptoms. For individuals with symptomatic knee osteoarthritis, adding manual therapy treatment in the form of mobilization with movement or Maitland joint mobilization to the baseline exercise program delivers advantages beyond what the same exercises alone may provide. Maitland concept is a patient driven model of passive joint mobilization, where passive oscillatory movements are performed at the limit of the range. Whereas, Mulligan’s mobilization with movement is a relatively new concept that utilises pain-free low-velocity joint mobilization techniques that can include an active movement component. Manual therapy appears to be effective in relieving symptoms but the effects on pain, joint motion, strength, physical functions and quality of life is still needed to be further explored. There are sufficient evidences for use of manual therapy techniques like mobilization with movement and Maitland joint mobilization in knee osteoarthritis patients but the comparison of the effects of these manual therapy techniques is still controversial. Thus, this study aims to compare the effects of mobilization with movement and Maitland joint mobilization using outcome measure VAS, Universal Goniometer, MicroFET3, TUG, 30s chair stand test, WOMAC CRD Pune and WHOQOL-BREF in knee osteoarthritis patients.

Null hypothesis- mobilization with movement and Maitland joint mobilization will be equally effective as an adjunct to institution-based exercise program on pain, Rom, strength, functional status & quality of life in knee osteoarthritis patients.

Alternative hypothesis 1- mobilization with movement will have better effects than Maitland joint mobilization as an adjunct to institution-based exercise program on pain, ROM, strength, functional status & quality of life in knee osteoarthritis patients.

Alternative hypothesis 2- Maitland joint mobilization will have better effects than mobilization with movement as an adjunct to institution-based exercise program on pain, ROM, strength, functional status & quality of life in knee osteoarthritis patients.
 
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