A comparative study to evaluate efficacy,safety and cost effectiveness between Tramadol and Diclofenac with and without proton pump inhibitor in patients with knee osteoarthritis.

Arthritic pain is common and is associated withworst functional outcome and poorer quality of life. Most commonly used drug inclinical practice is Tramadol and Diclofenac. Routinely NSAIDS are given alongwith PPI.In addition to anti-secretory effects, however, PPIs have shown anti-inflammatoryeffects . But the role of PPIs as anti-inflammatory agents in addition to acidlowering property  in osteoartharitis andcost effectiveness remains to be explored. In developing countries it is veryimportant to assess what drugs may decrease the subsequent use of medical careresources considering their adverse events that are known to have a significantincrease in medical care costs of patients with osteoarthritis..Keeping the above limitations inmind we have designed a study to evaluate cost effectiveness and safety betweentwo most commonly used drugs.

This study is a randomized, active control, parallel group, single centre comparative study to evaluate cost effectiveness and safety between Tramadol(200mg SR OD) and Diclofenac(100mg SR OD) with and without proton pump inhibitor(omeprazole 20 mg)  in 94 patients with knee osteoarthritis.Drugs will be given for two weeks and if  necessary drug will be continued with rescue medication given for 2 more wks.

The primary outcome measures will be by KOOS questionnaire:The Knee injury and Osteoarthritis Outcome Score,  and pain assessment by Visual analouge scale at 2 and 4 wks.Cost  effectiveness ratio for different groups will be  calculated by dividing the cost of treatment by its clinical outcome to yield the ratio in terms of rupees.  Adverse events spontaneously reported by patients and adverse events observed by the investigator will be recorded at each visit.