1. 2016;19;E1049-E1053Effectiveness and Impact of Capsaicin 8% Patch on Quality of Life in Patients with Lumbosacral Pain: An Open-label Study
   Prospective Study
   Panagiotis Zis, MD, PhD, Nikolitsa Bernali, MD, Erifili Argira, PhD, Ioanna Siafaka, PhD, and Athina Vadalouka, MD, PhD.

BACKGROUND: Capsaicin 8% patch (Qutenza™) is mainly used to treat postherpetic neuralgia and HIV-associated neuropathy. Evidence of the efficacy of Qutenza in other forms of neuropathic pain is lacking.

OBJECTIVE: To evaluate the analgesic effect and the impact on quality of life after a single application of the capsaicin 8% cutaneous patch in patients with lumbosacral pain.

STUDY DESIGN: Prospective open-label study of capsaicin 8% patch in patients with lumbosacral pain.

SETTING: Outpatient Pain and Palliative Care Center.

METHODS: All recruited patients were evaluated prior to capsaicin 8% patch administration and were followed-up at 2 weeks, at 8 weeks, and at 12 weeks post administration. Visual analog scale (VAS) was used to record pain intensity and EQ-5D was used to assess the quality of life of the participants.

RESULTS: Ninety patients met our inclusion criteria (54.4% men, mean age 59.1 ± 9.2 years). At baseline the mean VAS score of the participants was 7.6 ± 0.7. A statistically significant reduction of the VAS score between baseline and week 2 (mean VAS score 5.6 ± 1.1, P < 0.001) was observed. The therapeutic effect further continued between week 2 and week 8 (mean VAS score 3.2 ± 1.2, P < 0.001) and between week 8 and at endpoint at week 12 (mean VAS score 2.6 ± 1.1, P < 0.001).

Between baseline and weeks 2, 8, and 12 (end-point) a significant improvement in all 5 dimensions of EQ-5D (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) was observed (P < 0.001)

LIMITATIONS: As it is an open-label study, a prospective randomized placebo-controlled study should be designed to confirm the effectiveness of capsaicin 8% patch in patients with lumbosacral pain.

CONCLUSIONS: Administration of the capsaicin 8% patch resulted in a significant relief of neuropathic pain and a significant improvement of the quality of life of patients with lumbosacral neuropathic pain.

Key words: Lumbosacral pain, peripheral pain, Qutenza, neuropathic pain, capsaicin, patch, quality of life, effectiveness