Background/Purpose: Osteoarthritis (OA) is a common progressive joint disease and a leading cause of musculoskeletal pain and functional disability worldwide. Despite various interventional treatment approaches such as non-steroidal antinflammatory drugs (NSAIDs), pain management of OA remains suboptimal. Among NSAIDs, ketoprofen lysine salt (KSL) has a marked analgesic effect, through both its anti-inflammatory action and a central action. The primary aim of our study was to evaluate the efficacy of KSL in reducing the severity of osteoarticular pain. Secondary aims were grip strength assessment, duration and severity of swelling, acute exacerbations frequency and inflammation grade.

Methods: This was a retrospective and prospective clinical trial, including 58 post-menopausal women (>50 years) affected by primary osteoarthritis of the hand. All patients (pz) reported pain and swelling at least in 3 interphalangeal joints (IF) of the hands. Pz were randomized into 2 groups: Group A (30 pz, 105 IF) took KSL (160 mg/die) for 10 days plus glucosamine (500 mg) and chondroitin sulphate (400 mg) for 20 days. Group B (28 pz, 95 IF) received only glucosamine (500 mg) and chondroitin sulphate (400 mg) for 20 days. Pulsed wave (PW) Doppler (Esaote Mylab 25 Gold equipped with a 12-18 MHz multi-frequency transducer) was performed on the dorsal and palmar side of IF, with longitudinal and transverse scans, assessing synovitis/effusion and PW-Doppler signal (OMERACT scale: 0-3). Clinical assessments of pz were performed at day 1 (T0) and after 5,10,15,20 days (T1,T2,T3,T4). At each visit Visual Analog Scale for Pain (VAS Pain) and grip strength were recorded.

Results : Pain improved in 24 Group A pz (mean VAS score decreased from 70 to 16) and 70/105 IF showed an improvement in PW Doppler. None of these pz reported exacerbations. Also grip strength improved by an average of 50%. On the contrary, only 10/28 Group B pz obtained an improvement of pain (mean VAS score decreased from 70 to 55). PW Doppler improved in 20/95 IF, ≥1 exacerbations were reported by 12 pz and grip strength remained unchanged.

Conclusion : These results demonstrate that the addition of KSL is highly effective in reducing joint inflammation and pain in women with primary osteoarthritis of the hand. The reduction in the number of exacerbations in the group of patients treated with KSL also suggests that the use of this NSAID may reduce relapses lessening the bone and cartilage damage and joint deformities.