Rest pain (mm). Tiptoe-walking pain (mm). Range of motion (degrees) Increase from baseline Global patient satisfaction (S-point scale) Adverse events, pain only (number of patients) N/A Baseline (n = 47) 41 .2 x 3.1Ï 68.9 t 5.9 6.3 t 4.1 3.1 t 1.3 9Wk (n = 47) 29.4 t 3.3Ï 40.2 x 4.1+ 26.3 t 10.51 16" 4.86 t 0.2 2 16 Wk (n = 47) 30.4 r 2.9ï 32.8 t 3.1r 32.6 x97t 22" 4.51 t 0,3 0 Follow-up (n = 47) 26.1 x2.61 59.0 t 18.4S 28.7 t7.51 19" 4.6 t 0.1311 0 .Measured on a 100-mm visual analoo scale. ï P
activi$ in addition to standard pain and disability assessment. " Viscosupplementation with intra- articu - lar FIA appears to extend pain relief beyond the product's biological kinetics.'o The structure-modifying effects (eg, improved chondrocyte density, reduced synovial inflammation, increased slmovial repair process) in the osteoarthritic joint may relate to pain relief,''rz'ts and this is an area of active investigation. lVhile the evidence regarding viscosupplementation with FIA in the knee continues to evolve,'limited evidence and experience existwith other joints, and none, to ou-r hlowledge, is lcror,rrn in small articular joints. In two limited studies6''6 in patients who had painful shoulders, intra-articular FIA injection improved pain and fr.rnction; therefore, similar efficary in other articular joints requires ongoing investigation. Limitations. The present study had several limitations that could affect the general applicability of the results. This unblinded, open-label, unrandomized trial had no active comparator €unong a small number of otherwise healthy subjects. Future studies should include larger subject numbers to achieve appropriate statistical power and use a randomized design that would include an active comparator treatment arm to further address efficary and safety. We used a 1.0-mL HA intra-articular injection administered once weekly over B consecutive weeks. This was based on the clinical experience of the primary investigator with differing volumes and treatment schedules in this population and was in accordance with previous weekly treatment schedules for HA in the knee. Formal dose-response studies would determine the optimal treatment course for osteoarthritis of the first MTP joint. Gonclusions and Recommendations HA injection produced a significant, long-term improvement in pain and function in older patients who had osteoarthritis of the fust MTP joint. Because of the small articular space, we used 1.0 mL of HA without any associated local and systemic adverse events. The regimen used in this study produced high patient satisfaction, was associated with limited need for concomitant therapies during follow-up, and appeared acceptable as a repeated, long-term therapeutic option. PSM REFERENCES l. Creamer Il Hochberg MC: Osteoarthritis. Lancet 1997;350 (9076):503-508 2. Maheu E, Ayral X, Dougados M: A hyaluronan preparation (500-730 kDa) in the treatment of osteoarthritis: a review of clinical trials with Hyalgan. Int I Clin Pract 2002;56(10):BOa- Bt3 3. Petrella RL DiSilvestro MD, Hildebrand C: Effects of hyaluronate sodium on pain and physical functioning in osteoarthritis of the knee: a randomized. double-blind. placebo-controlled clinical trial. Arch Intern Med 2002;162 (3):292-298 4. Frizziero L, Govoni E, Bacchini P: Intra-articlar hyaluronic acid in tre treatment of osteoarthritis of the knee: clinical and morphological study. 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