Authors: Jeffrey A Gudin, Derek T Dietze, Peter L Hurwitz.
Rationale: Evidence-based multimodal approaches to pain management include use of combination pharmacotherapy, nonpharmacological, and behavioral interventions. Much focus has been on the use of topically applied analgesics in order to spare the need for oral therapies. Topical analgesics, including pain relief patches, have proven a valuable strategy in the management of mild to moderate levels of pain. Advancements have allowed for the incorporation of nanotechnology into the development of patch therapies, yet there remains a paucity of data surrounding these products.
The purpose of this IRB-approved, minimal risk study was to evaluate patients with mild, moderate, and severe pain and evaluate perceptions of pain treatment with the use of a novel, non-drug, and nanotechnology-based topical pain-relieving patch. An interim analysis was undertaken to screen for unanticipated adverse events and proof of concept for effectiveness.
Methods: This interim analysis evaluated the efficacy of a topical pain-relieving patch (Kailo Pain Patch®, Pain Relief Technologies, USA) in reducing Brief Pain Inventory (BPI) scores in patients experiencing mild, moderate, severe pain. 66 adult patients (39 females, 27 males) with arthritic, neuropathic, or musculoskeletal pain received patches for 30 days. Surveys were administered at baseline, 14-, and 30 days to assess changes in pain severity, pain interference, oral pain medication use, side effects, and satisfaction with patch use.
Results: Treatment group paired data were collected. Mean BPI Severity score decreased 71% (5.2 to 1.5/10;P< .001) and mean BPI Interference score decreased 67% (4.5 to 1.5/10;P< .001) No side effects of treatment were reported. 98% of patients reported “less” or “a lot less” usage of oral medications. 97% of patients were very/extremely satisfied with the patch and preferred the pain-relieving patch to oral medications. Results showed Quality of Life (QoL) improvements in mood, relations with other people, sleep, walking ability, and enjoyment of life.
Conclusions: Interim results indicate that this novel, nanotechnology-formulated topical analgesic pain-relieving patch can reduce BPI pain severity and interference scores and related pain for adult patients with arthritic, neuropathic, and musculoskeletal pain.