Poster Number-52 - Capsaicin 8% Topical System combined with Electric cell-Signaling Treatment (EcST) for the treatment of Painful Diabetic Peripheral Neuropathy (PDPN) of the feet: a case series

Capsaicin 8% Topical System combined with Electric cell-Signaling Treatment (EcST) for the treatment of Painful Diabetic Peripheral Neuropathy (PDPN) of the feet: a case series

Purpose:

Painful diabetic peripheral neuropathy (PDPN) effects approximately 5.6 million people in the US.¹ Although a variety of treatments are available, many patients continue to suffer from a lack of adequate pain control and require multiple modalities to sufficiently reduce the symptoms of PDPN.² This case series examines the effects of two combined modalities, capsaicin 8% topical system* followed by Electric cell-Signaling Treatment (EcST), for the reduction of painful DPN symptoms.

Methods:

Six adult patients naïve to both treatments were selected for this retrospective case series at the Neuropathy Treatment Clinic of Oklahoma. Each patient had type 2 diabetes (T2D) with good glycemic control, and unresolved clinically diagnosed PDPN of the feet. On Day 0, patients were treated with capsaicin 8% topical system on their feet for 30 min. On Day 7, patients began a prescribed 3-month (24 treatment sessions) of EcST. Baseline data were collected for pain as well as other symptoms reported by patients (burning, tingling, numbness, tightness, stabbing, throbbing) on Day 0 with subsequent data collection on Days 7, 30, 60 and 90. Percent pain reduction was compared to baseline at each timepoint. All other symptoms were measured on a numeric pain rating scale (NPRS; 0-10) at each of the time points. 

Results:

Two females and four males with an age range from 72 to 90 year old and a mean age of 79.8 years old were included in the case series. On average, patients had painful DPN for 9.5 years and T2D for 15.3 years (mean baseline HbA1C 6.47%). Common comorbidities included hypertension (n=3), hyperlipidemia (n=3), atrial fibrillation (n=3), bilateral lower extremity edema (n=3), and hypothyroidism (n=2). Results showed mean reductions in pain from baseline at each time point (Day 7: 43.3%, Day 30: 48.4%, Day 60: 62.5%, and Day 90: 68.3%). The most prevalent patient-reported symptoms included tingling (n=6), burning (n=5), and numbness (n=4), which were also reduced from baseline to Day 90 by 40%, 49%, and 58%, respectively. No serious adverse events were reported; however, all patients experienced mild and transient erythema of the treatment area following application of the capsaicin 8% topical system.

Conclusion:

Multimodal treatment is often employed for adequate pain relief. In this case series, six adults with painful DPN were treated with capsaicin 8% topical system followed by EcST. The results showed a clinically meaningful effect with regard to pain relief, burning, tingling, and numbness. The capsaicin 8% topical system works as a neurolytic de-innervation agent and it has been shown to reduce epidermal nerve fiber density significantly after 1 week.³ EcST acts through multiple biochemical, biomechanical, and other physiological mechanisms to stimulate nerve regeneration.⁴ This case series suggests that combining these two treatment modalities may reduce the symptoms of painful DPN; however, more data are needed to understand these effects more accurately.

* QUTENZA® (capsaicin) 8% topical system is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and for neuropathic pain associated with painful diabetic peripheral neuropathy (PDPN) of the feet.

References: 1. International Diabetes Federation. IDF diabetes atlas, ninth edition. 2019
2. Iqbal Z, et al. Clin Ther. 2018;40(6):828-850
3. Kennedy WR, et al. J Pain. 2010;11(6):579-587
4. Odell RH Jr, Pain Phys. 2008;11:891-907