906-P: Safety and Efficacy of Polmacoxib for Diabetes-Associated Frozen Shoulder—Prospective Randomized Control Trial

Introduction and Objective: Adhesive Capsulitis (AC) or frozen shoulder is a common complication of uncontrolled T2DM having prevalence of 10-39%. Shoulder pain and disability index(SPADI) is visual analogue scale tool to quantify disease severity in AC. Polmacoxib, a novel COX2 inhibitor is indicated for long term analgesia in osteoarthritis without CV side effects. Besides COX2 Inhibition it has high affinity to carbonic anhydrase (CA) enzyme. A preferential binding of Polmacoxib to CA reduces COX2 effects in cardiovascular system where it is present in abundance. Thus, preventing CV side effects. Prolonged effective analgesic, physiotherapy and strict glucose control are main stay treatment of AC. Objective was to study Polmacoxib as safe and effective analgesic in T2DM associated AC.

Methods: Eighty-six participants with T2DM and AC without CV disease were divided into 2 groups (43 cases and 43 comparators) after randomization. SPADI tool used before start of therapy and then weekly till 6 weeks in both groups. Increase in wight 5% and heart rate 10% above baseline, new onset pedal edema &/or right hypochondrial tenderness, easy fatigability &/or unexplained cough were measured signs of fluid accumulation and incipient CHF and considered early study termination. Standard diabetes care and physiotherapy given to both groups. Cases were given oral Polmacoxib 2 mg/day and Comparators oral tramadol sos for pain. A >80% SPADI score reduction was considered cut-off for effective analgesia.

Results: one case lost follow up, so excluded. Thirty six out of 42 cases whereas 28 out of 43 comparators showed >80% reduction in SPADI score at 2 wks. which was maintained till 6 wks. The proportion of participants who reported reduction in pain and disability above cutoff differ by use of Polmacoxib, X2 (1, N = 85) = 4.84, p < .05. No participant showed any sign of CHF during study.

Conclusion: Polmacoxib was an effective and safe analgesic for prolong use in adhesive capsulitis due to T2DM