PALM SPRINGS, CA — Diclofenac sodium topical solution proved effective and well-tolerated in patients with heel pain, including plantar fasciitis, according to results of a study presented at the 2012 American Academy of Pain Medicine Annual Meeting.
Srinivas Nalamachu, MD, and colleagues from International Clinical Research of Leawood, KS, conducted a four-week, single-site, randomized, parallel, open-label study to evaluate the efficacy and safety of diclofenac sodium topical solution in heel pain. Patients were enrolled in the study if they had clinical evidence of soft-tissue heel pain, including plantar fasciitis (mean age 52.6 years [range 18–75 years]; 75% female).
Forty patients were randomized to receive 20 drops (Group 1) or 40 drops (Group 2) of diclofenac sodium topical solution to the heel twice daily, titrated to three times daily if needed. Overall, 65% and 30% of patients in Groups 1 and 2, respectively, were titrated to three-times-daily dosing. The primary endpoint was change in pain severity from baseline based on a visual analog scale (VAS; 1–100), measured at Weeks 1, 2, and 4. Global assessment of treatment satisfaction, adverse events (AEs), and relationships to treatment were also recorded.
Mean pain scores decreased by 8.1 in Group 1 and 3.9 in Group 2 after Week 1, and by 10.4 and 11.8, respectively, by Week 4. A 30% reduction in baseline pain scores at the final visit was observed in 50% of patients in Group 1 and 45% in Group 2, a 50% reduction was observed in 40% and 35% of patients, respectively. The majority of patients (82.5%) were very satisfied or satisfied with treatment. AEs were reported in six (0.2%) patients; all were considered mild, and only one (dryness at application site) was considered by investigators to be likely related to diclofenac sodium topical solution.
The study authors concluded that diclofenac sodium topical solution administered twice daily or three times daily is effective and well-tolerated in patients with heel pain, but that additional, placebo-controlled studies are needed in this patient population.