R Baron1, R D Treede2, F Birklein3, T Cegla4, R Freynhagen5, M L Heskamp6, K U Kern7, C Maier8, R Rolke9, S Seddigh10, C Sommer11, S Ständer12, C Maihöfner13. 1. a Division of Neurological Pain Research and Therapy, Department of Neurology , Universitätsklinikum Schleswig-Holstein , Campus Kiel , Germany. 2. b Chair of Neurophysiology, Medical Faculty Mannheim , Heidelberg University , Germany. 3. c Department of Neurology , University of Mainz , Germany. 4. d Department of Anesthesiology and Pain therapy , St. Josef Hospital , Wuppertal , Germany. 5. e Department of Anaesthesiology , Benedictus Hospital Tutzing and Technische Universität München , Germany. 6. f Medical Department , Astellas Pharma GmbH , Germany. 7. g Institute of Pain Medicine/Pain Practice , Wiesbaden , Germany. 8. h Department of Pain Medicine , BG University Hospital Bergmannsheil GmbH, Ruhr-University Bochum , Germany. 9. i Department of Palliative Medicine , Medical Faculty RWTH Aachen University , Germany. 10. j Department of Neurology , BG-Klinikum Duisburg , Germany. 11. k Department of Neurology , University of Würzburg , Germany. 12. l Competence Center Chronic Pruritus, Department of Dermatology , University Hospital of Münster , Germany. 13. m Department of Neurology , General Hospital Fürth , Fürth , Germany.
Abstract
BACKGROUND AND OBJECTIVE: The treatment of neuropathic pain due to low-back (lumbosacral) radiculopathies, a common source of neuropathic pain, is challenging and often requires a multimodal therapeutic approach. The capsaicin 8% patch is the first topical analgesic licensed for peripheral neuropathic pain. To evaluate this treatment, a subset of patients with painful radiculopathy (lumbar and cervical, including ventral and dorsal rami) enrolled into the multicenter, non-interventional QUEPP study (Qutenza 2 - safety and effectiveness in peripheral neuropathic pain) was analyzed. METHODS: Of the 1044 study participants, 50 were diagnosed with painful radiculopathy as only peripheral neuropathic pain syndrome and were eligible for evaluation. Patients received a single treatment (visit 1) with follow-up visits 2-5 at weeks 1-2, 4, 8 and 12. Parameters assessed at all visits included pain intensity, neuropathy symptoms and side effects. Quality of life (SF-12) and painDETECT 1 questionnaires were completed at baseline and final visit. Data was analyzed by patch application site and duration of pain. RESULTS: Topical treatment led to a significant decrease of pain intensity between weeks 1/2 and week 12 versus baseline at the application sites representing dermatomes of ventral (N = 26) and dorsal rami (N = 13) of spinal nerves. A significant decline (p ≤ .001) of numeric pain rating scale scores was observed between weeks 1/2 following patch application and the end of observation (week 12) in the overall radiculopathy group (N = 50), and the groups with either 3 months to 2 years (N = 14) or >2 years (N = 23) duration of pain. Pain relief of at least 30% was observed in 50.0%, 71.4% and 39.1% of patients in the respective groups. Four patients experienced in total seven adverse drug reactions (application site pain or pruritus). CONCLUSION: Effective neuropathic pain relief was observed after patch application within the innervation territories of both dorsal and ventral branches of the spinal nerve. Further controlled randomized trials are indicated.
BACKGROUND AND OBJECTIVE: The treatment of neuropathic pain due to low-back (lumbosacral) radiculopathies, a common source of neuropathic pain, is challenging and often requires a multimodal therapeutic approach. The capsaicin 8% patch is the first topical analgesic licensed for peripheral neuropathic pain. To evaluate this treatment, a subset of patients with painful radiculopathy (lumbar and cervical, including ventral and dorsal rami) enrolled into the multicenter, non-interventional QUEPP study (Qutenza 2 - safety and effectiveness in peripheral neuropathic pain) was analyzed. METHODS: Of the 1044 study participants, 50 were diagnosed with painful radiculopathy as only peripheral neuropathic pain syndrome and were eligible for evaluation. Patients received a single treatment (visit 1) with follow-up visits 2-5 at weeks 1-2, 4, 8 and 12. Parameters assessed at all visits included pain intensity, neuropathy symptoms and side effects. Quality of life (SF-12) and painDETECT 1 questionnaires were completed at baseline and final visit. Data was analyzed by patch application site and duration of pain. RESULTS: Topical treatment led to a significant decrease of pain intensity between weeks 1/2 and week 12 versus baseline at the application sites representing dermatomes of ventral (N = 26) and dorsal rami (N = 13) of spinal nerves. A significant decline (p ≤ .001) of numeric pain rating scale scores was observed between weeks 1/2 following patch application and the end of observation (week 12) in the overall radiculopathy group (N = 50), and the groups with either 3 months to 2 years (N = 14) or >2 years (N = 23) duration of pain. Pain relief of at least 30% was observed in 50.0%, 71.4% and 39.1% of patients in the respective groups. Four patients experienced in total seven adverse drug reactions (application site pain or pruritus). CONCLUSION: Effective neuropathic pain relief was observed after patch application within the innervation territories of both dorsal and ventral branches of the spinal nerve. Further controlled randomized trials are indicated.
Authors: Sven Schmiedl; David Peters; Oliver Schmalz; Anke Mielke; Tanja Rossmanith; Shirin Diop; Martina Piefke; Petra Thürmann; Achim Schmidtko Journal: Front Pharmacol Date: 2019-07-25 Impact factor: 5.810