Changes in pain and concurrent pain medication use following compounded topical analgesic treatment for chronic pain: 3- and 6-month follow-up results from the prospective, observational Optimizing Patient Experience and Response to Topical Analgesics study

Abstract

Background

Opioids and other controlled substances prescribed for chronic pain are associated with abuse, addiction, and death, prompting national initiatives to identify safe and effective pain management strategies including topical analgesics.

Methods

This prospective, observational study evaluated changes from baseline in overall mean severity and interference scores on the Brief Pain Inventory scale and the use of concurrent pain medications at 3- and 6-month follow-up assessments in chronic pain patients treated with topical analgesics. Changes in pain severity and interference and medication usage were compared between treated patients and unmatched and matched controls.

Results

The unmatched intervention group (unmatched-IG) included 631 patients who completed baseline and 3-month follow-up surveys (3-month unmatched-IG) and 158 who completed baseline and 6-month follow-up assessments (6-month unmatched-IG). Baseline and 3-month follow-up data were provided by 76 unmatched controls and 76 matched controls (3-month unmatched-CG and matched-CG), and 51 unmatched and 36 matched patients completed baseline and 6-month follow-up surveys (6-month unmatched-CG and matched-CG). Baseline demographic characteristics and mean pain severity and interference scores were similar between groups. There were statistically significant decreases from baseline in mean pain severity and interference scores within the 3- and 6-month unmatched-IG (all P<0.001). Significantly greater decreases in the mean change from baseline in pain severity and interference scores were evident for the 3- and 6-month unmatched-IG versus unmatched-CG (all P<0.001), with similar results when the 3- and 6-month matched-IG and matched-CG were compared. A higher percentage of the 3- and 6-month unmatched-IG and matched-IG de-escalated use of concurrent pain medications (all P<0.001), while significantly higher percentages of the unmatched-CG and matched-CG escalated medication use. Side effects were reported by <1% of the unmatched-IG.

Conclusion

Topical analgesics appear to be effective and safe for the treatment of chronic pain, with randomized controlled trials needed to confirm these findings.

Keywords:

• chronic pain
• opioids
• pain interference
• pain severity
• topical analgesics
• OPERA

Acknowledgments

Carole Alison Chrvala, PhD, of Health Matters, Inc., is acknowledged for her assistance with writing and editing this manuscript. This study by Clarity Science was funded by Safe Harbor Compliance and Clinical Services, Annie’s Apothecary, Boothwyn Pharmacy, and Cypress Compounding Pharmacy.

Disclosure

Jeffrey A Gudin and Michael J Brennan have received compensation from Clarity Science for their roles as principal investigators and for providing protocol-required services for the study. E Dennis Harris and Peter L Hurwitz are employees of Clarity Science. James D Strader is the CEO of Safe Harbor Compliance and Clinical Services. Derek T Dietze received compensation for study statistical analyses. The authors report no other conflicts of interest in this work.