This randomized, open label, comparative, parallel group, prospective study will be conducted 

in the Department of Pharmacology and Orthopaedics, after obtaining approval and clearance 

from the Institutional Ethics Committee. Written informed consent (Annexure-1) will be 

obtained from all the study subjects, after fulfilling the following inclusion and exclusion 

criteria. Subjects (n-110) will be divided into 2 groups at the Day 1 (visit 0, baseline) based on 

computer-generated randomisation in 1:1 allocation.:  

1.OA Knee+NSAIDS - Group (N)  

2.OA Knee+NSAIDS+Physiotherapy - Group (P)  

Subjects will be followed up at Day 7 (visit 1), Day 14 (visit 2) and Day 21 (visit 3). The 

standard NSAID which will be given to all the subjects is Aceclofenac 100mg twice a day for 

5 days. Physiotherapy exercises conducted will be Wax therapy, Interferential Therapy (IFT) 

from Day 1 to Day 10. Physical exercises like Isometric quadriceps and Isometric hamstring 

exercises from Day 6 to Day 21. 

Group N (n=55) will receive Aceclofenac 100mg twice a day for 5 days. 

Group P (n=55) will receive Aceclofenac 100mg twice a day for 5 days along with 

standard Physiotherapy for OA knee. 

For each subject, demographic data and detailed clinical history, including medical history, 

drug history, previous history of drug reactions will be collected and recorded, and a thorough 

physical and knee joint examination will be done. Routine laboratory investigations and X ray 

anterior-posterior/lateral of the bilateral knee joints will be done for all the subjects and noted 

down. X-rays of knee joints will be taken for diagnosis.  

The Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Arthritis 

Index (WOMAC) scores will be assessed at baseline and at each follow up and Global 

Assessment of Response to Therapy (GART) will be assessed at Day 21. The VAS score is 

graded from 0 to 10 according to patient’s response. WOMAC is a subjective score consisting 

of subscales in terms of pain, stiffness, and physical function. All the parameters will be graded 

on a scale of 0-4 depending on the severity, from none to severe. The reduction in WOMAC 

score indirectly indicates improvement in the QOL. If the VAS score is >3 after the 1st, 2nd and 

3rd visit, then subsequent doses of Aceclofenac 100mg BD will be given for 5 days and the 

time of administration will be noted for both the groups. The clinician and the patient 

independently will assess (GART) the efficacy of the intervention for both the groups at the 

end of the study (Day 21) on a 5-point scale (0-Poor, 1-Fair, 2- Good, 3-Very Good, 4

Excellent).