A Systematic Guideline by the ASPN Workgroup on the Evidence, Education, and Treatment Algorithm for Painful Diabetic Neuropathy: SWEET

Abstract

Introduction

Painful diabetic neuropathy (PDN) is a leading cause of pain and disability globally with a lack of consensus on the appropriate treatment of those suffering from this condition. Recent advancements in both pharmacotherapy and interventional approaches have broadened the treatment options for PDN. There exists a need for a comprehensive guideline for the safe and effective treatment of patients suffering from PDN.

Objective

The SWEET Guideline was developed to provide clinicians with the most comprehensive guideline for the safe and appropriate treatment of patients suffering from PDN.

Methods

The American Society of Pain and Neuroscience (ASPN) identified an educational need for a comprehensive clinical guideline to provide evidence-based recommendations for PDN. A multidisciplinary group of international experts developed the SWEET guideline. The world literature in English was searched using Medline, EMBASE, Cochrane CENTRAL, BioMed Central, Web of Science, Google Scholar, PubMed, Current Contents Connect, Meeting Abstracts, and Scopus to identify and compile the evidence for diabetic neuropathy pain treatments (per section as listed in the manuscript) for the treatment of pain. Manuscripts from 2000-present were included in the search process.

Results

After a comprehensive review and analysis of the available evidence, the ASPN SWEET guideline was able to rate the literature and provide therapy grades for most available treatments for PDN utilizing the United States Preventive Services Task Force criteria.

Conclusion

The ASPN SWEET Guideline represents the most comprehensive review of the available treatments for PDN and their appropriate and safe utilization.

Keywords:

• diabetes
• painful diabetic neuropathy
• neuropathy
• spinal cord stimulation
• chronic pain
• diabetic neuropathy

Abbreviation

A1c/ HbA1c, Glycated hemoglobin; AAN, American Academy of Neurology; ACCORD, Action to Control Cardiovascular Disease in Diabetes (study); ACT, Acceptance and Commitment Therapy; ACUDPN, Acupuncture in diabetic peripheral neuropathy; ASPN, American Society of Pain and Neuroscience; BDI, Beck Depression Inventory; BMT, Best medical therapy; BPI, Brief Pain Inventory; CBT, Cognitive behavior therapy; CDC, Centers for Disease Control and Prevention; CGRP, Calcitonin gene-related peptide; CI, Confidence interval; CMM, Conventional medical management; CPAQ, Chronic Pain Acceptance Questionnaire; CRPS, Complex regional pain syndrome; DCCT, Diabetes Control and Complications Trial (study); DM, Diabetes mellitus; DRAE, Drug-related adverse event; DRG-S, Dorsal root ganglion stimulation; ePNS, Electrical peripheral nerve stimulation; EQ-5D, EuroQOL 5-dimension questionnaire; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue Scale; FBSS, Failed back surgery syndrome; FDA, Food and Drug Administration (United States); HF, High frequency; HIV, Human immunodeficiency virus; IDD, IDT, Intrathecal drug delivery, intrathecal drug therapy; IENFD, Intraepidermal nerve fiber density; IT, Intrathecal; LOS, Length of stay; LPN, Lateral plantar nerve; MBSR, Mindfulness-based stress reduction; MCN, Medial calcaneal nerve; MDNS, Michigan Diabetic Neuropathy Score; MM, Mindfulness meditation; MPN, Medial plantar nerve; mPNS, Magnetic peripheral nerve stimulation; MRI, Magnetic resonance imaging; MT, Mindfulness therapy; NCV, Nerve conduction velocity; NePIQOL, Neuropathic Pain Impact on Quality of Life Questionnaire; NeuroQoL, Neuropathy-Specific Quality of Life Questionnaire; NIS, Noninvasive stimulation; NMDA, N-methyl-D-aspartate (glutamate receptor); NNT, Number-needed-to-treat; NPS, Neuropathic Pain Scale; NRS, Numeric rating scale; NPRS, Numeric pain rating scale; ODI, Oswestry Disability Index; PACC, Polyanalgesic Consensus Conference; PCS, Pain Catastrophizing Scale; PDN, Painful diabetic neuropathy; PENS, Percutaneous electrical nerve stimulation; PGIC, Patient Global Impression of Change; PHQ9, Patient Health Questionnaire-9; PJI, Periprosthetic joint infection; PN, Peripheral neuropathy; PNS, Peripheral nerve stimulation; POMS, Profile of Mood States; PROM, Patient-reported outcome measure; PRP, Platelet rich plasma; PSQI, Pittsburgh Sleep Quality Index; PSS, Perceived Stress Scale; QOL, Quality of life; QST, Quantitative sensory test; RCT, Randomized controlled trial; SCS, Spinal cord stimulation; SD, Standard deviation; SF-12/ SF-36, Short Form questionnaire; health-related quality of life (12-/ 36-item); SF-MPQ, Short form McGill Pain Questionnaire; SNAP, Sensory nerve action potential; SNRI, Serotonin-norepinephrine reuptake inhibitor; SOC, Standard of care; SSI, Surgical site infection; STROBE, Strengthening the Reporting of Observational Studies in Epidemiology; SWEET, Systematic guideline process to outline the current state of the art in treatment of painful diabetic neuropathy; T1DM, Type 1 diabetes mellitus; T2DM, Type 2 diabetes mellitus; TAU, Treatment as usual; TCA, Tricyclic antidepressant; TRPV1, Transient receptor potential vanilloid 1; USPSTF, United States Preventative Services Task Force; VADT, Veterans Affairs Diabetes Trial (study); VAS, Visual analog scale; VASPI, Visual analog scale of pain intensity; WHYMPI, West Haven Yale Multidimensional Pain Inventory.

Acknowledgments

Editing was provided by Allison Foster, PhD, of Foster Medical Communications.

Disclosure

DS is a consultant to Abbott, Painteq, Saluda, Mainstay, Surgentec, Nevro, and holds stock options with Painteq, Neuralace, Mainstay, Vertos, and SPR. TRD is a consultant for Abbott, Vertos, SpineThera, Saluda Medical, Cornerloc, SPR Therapeutics, Boston Scientific, PainTeq, Spinal Simplicity, and Biotronik; an advisory board member for Abbott, Vertos, SPR Therapeutics, and Biotronik; has a pending patent with Abbott; and has received research funding from Abbott, Vertos, Saluda, Mainstay, SPR Therapeutic, Boston Scientific, and PainTeq. RSD receives investigator-initiated research grant funding from Nevro Corp and Saol Therapeutics that is paid to his institution. NK is a consultant to Saluda Medical and serves on an advisory board for Vertos Inc. ZH has agreements with Averitas, PainTEQ, SPR, Vertos, and Nevro. SGP is consultant to Bioness, SPR Therapeutics, Nalu Medical, and EBT Medical; receives royalties from Oxford University Press and Wolters Kluwer, and receives research grants from Biotronik, Medtronic, Nevro Corp, and Abbott. VTF receives research funding from Nevro Corporation part of an investigator-initiated study grant that is not related to this manuscript. SMF is a consultant to Abbott, Medtronic, Saluda, Vertos, CornerLoc, and Mainstay; has equity in SurgenTec, SynerFuse, Aurora Spine, Thermaquil, SPR Therapeutics, Saluda, CornerLoc, PainTeq, SpineThera, and Celeri; and has research agreements with Aurora, Mainstay, Medtronic, Abbott, Vertiflex, Saluda, CornerLoc, and Biotronik. MNM has consulting agreements with Abbott, Nalu Medical, BiotronikNEURO, and SI Bone Inc.; and serves on the scientific advisory board of BiotronikNEURO. MN is a consultant for Nevro. DWL is a consultant for Abbott, Medtronic, Boston Scientific, Biotronik, Mainstay Medical, and Petal Surgical. LK serves on advisory boards for Avanos, Biotronik, Medtronic, Gimer, Neuralace, Neuros, Nevro, PainTEQ, and Presidio; and has research agreements with Avanos, Neuros, Nevro, Fus Mobile, Saluda, and Nalu. MDB is a consultant for Neuralace Medical and Boston Scientific. EAP has received research support from Mainstay, Medtronic, Nalu, Neuros Medical, Nevro Corp, ReNeuron, SPR, and Saluda, as well as personal fees from Abbott Neuromodulation, Biotronik, Medtronic Neuromodulation, Nalu, Neuros Medical, Nevro, Presidio Medical, Saluda, and Vertos; and holds stock options from SynerFuse and neuro42. KA is a consultant for Nevro, Saluda, Biotronik, Boston Scientific, and Presidio. MES is a consultant with Modoscript, Collegium, and Syneos Health (all outside of the scope of this work). The authors report no other conflicts of interest in this work.

Additional information

Funding

The SWEET guideline was supported by unrestricted educational grants from Abbott, Averitas, and Nevro.