A study to evaluate cost effectiveness and safety of pain killers with and without acid reducing drugs in patients having pain in knee.
- Conditions
- knee osteoartharitis
- Registration Number
- CTRI/2013/05/003618
- Lead Sponsor
- DrMehwishmajeed
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 94
- 1.Patients’ aged 45 years or older of either sex.
- 2.Patients consulting for non-traumatic knee pain/primary symptomatic knee OA.
- 3.Complying to the clinical American College of Rheumatology (ACR) criteria for osteoarthritis of the knee.
- 4.A score of 3 or more on the pain severity scale (0-10 scale).
- 5.Patient willing to provide informed written consent.
- Contra-indication for NSAID or Paracetamol use (these are: Gastrointestinal bleedings in history or active peptic ulcer, serious liver or kidney disease (glomerular filtration less than 30 ml/min), 2.
- An arthroplasty or osteotomy of the knee.
- Surgery or major trauma of the affected joint within the previous 6 months 4.Pregnancy and lactating women.
- 5.Patients who were treated with corticosteroid and hyaluronic injection to the target joint within two months prior to the study medication administration.
- Patient having osteoarthritisfor more than 5 years.
- 7.Patients with Rheumatoid arthritis, Ankylosing spondylitis, Active gout or active pseudo-gout.
- 8.Patients advised physiotherapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 KOOS questionnaire:The Knee injury and Osteoarthritis Outcome Score 2 and 4 wks 2.Efficacy by VAS(Visual analogue score) questionnaire 2 and 4 wks 3.Cost effective analysis between Tramadol and diclofenac 2 and 4 wks 4.adverse effects of Tramadol and Diclofenac 2 and 4 wks
- Secondary Outcome Measures
Name Time Method 1. relation between demographic profile of patients and knee osteoarthritis 2.The quality of life of osteoarthritis patients by KOOS
Trial Locations
- Locations (1)
Department of Orthopedics Bharati Hospital ,
🇮🇳Pune, MAHARASHTRA, India
Department of Orthopedics Bharati Hospital ,🇮🇳Pune, MAHARASHTRA, IndiaDr MehwishmajeedPrincipal investigatormehwishmajeed@rocketmail.com