Effectiveness of physiotherapy in comparative assessment of pain and quality of life in patients with mild knee osteoarthritis receiving non-steroidal anti-inflammatory drug therapy

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).