硬膜外脊髓电刺激治疗慢性疼痛德国指南（2025）

ABSTRACT

Introduction: Epidural spinal cord stimulation (SCS) or dorsal root ganglion stimulation (DRG-S) is a neuromodulatory, reversible interventional procedure for patients with pain who cannot be adequately treated with conservative and less invasive means. This review provides the recently updated German recommendations for SCS and DRG-S, followed by a standardized diagnostic and therapeutic procedure.

Objective: The purpose of this work is to present the current evidence-based results of SCS, including DRG-S, for various neuropathic and nonneuropathic pain conditions. Moreover, it aims to optimize the treatment of patients with chronic pain for whom neuromodulation can be a component in the treatment concept of multimodal pain therapy.

Materials and Methods: A systematic literature search was conducted based on a Cochrane analysis, followed by search strategies in the common data bases (PubMed, Medline, and Embase). The relevant literature was reviewed and discussed within working groups. Finally, evaluation of evidence and identi fi cation of recommendations was performed by members of the guideline commission comprising representatives of relevant medical societies in Germany.

Results: The fi rst German guideline on SCS was published in April 2013. Any guideline has only limited validity (eg, in Germany, guidelines are valid for a maximum of fi ve years). Owing to the numerous publications in this fi eld, an update had become mandatory. On the basis of literature from 2013 to 2018, indications were newly identi fi ed or reevaluated. In addition, new methods were discussed, and predictors for treatment success were de fi ned as part of the psychologic assessment.

Conclusion: Neuromodulation, especially SCS, is based on the systematic study of treatment data. Real-world data are indispensable. Particularly in the current situation, in which fundamental questions about the value of SCS are being publicly discussed, sometimes in nonscienti fi c media, it is essential to publish systematic guidelines, on both a national and international level.

Keywords: Pain, PSPS, review article, SCS, spinal cord stimulation

INTRODUCTION

Chronic pain affects $30\%$ of the global population, imposing a signi fi cant personal and economic burden. 1 Three of the four leading causes of years lost to disability (back pain, musculoskeletal disorders, and neck pain) are chronic pain conditions. As a result, the annual costs of chronic pain in Europe amount to billions of euros. 2 Chronic pain can be classi fi ed as either neuropathic, arising from conditions such as nerve injuries, nerve compression, or metabolic diseases, or nonneuropathic, as observed in conditions such as angina pectoris, arterial occlusive disease, and Raynaud ’ s

disease. Only $30\%$ to $40\%$ of patients with neuropathic pain can be satisfactorily treated with medication. 3 , 4 After exhausting conservative treatment options, including individual and combined approaches such as medication, physical therapy, and psychologic/ psychotherapeutic interventions, and after ruling out psychologic or psychiatric contraindications (eg, inadequately treated mental disorders, substance addiction, unresolved dilemmas, or secondary gain), invasive techniques such as spinal cord stimulation (SCS) or dorsal root ganglion stimulation (DRG-S) — both reversible interventional neuromodulation procedures — may be considered. 5 Implantable neurostimulation technologies include traditional

40225 Duesseldorf, Germany. Email:

\*\* On behalf of the guideline committee.

dorsal column stimulation or SCS in addition to DRG-S owing to their close relation in both indication and technical methods. The high prevalence and incidence of chronic pain, the necessity for interdisciplinary treatment, and numerous technical innovations in pain management highlight the urgent need for evidence-based evaluation of cost-intensive invasive procedures within the broader context of multimodal pain therapy.

Although epidural SCS has been used for 40 years, it is only in recent years that signi fi cant studies have been published, providing evidence-based data on speci fi c indications and enabling the formulation of treatment recommendations. This review is based on the updated German guidelines for the use of SCS as listed in the guideline register of the Association of the Scienti fi c Medical Societies in Germany (AWMF) ( https://www.awmf.org/https://www. awmf.org/ ). The fi rst version of the guideline was published in 2013 and remained valid until 2015, making its renewal highly necessary. After AWMF approval in 2017, the guideline committee was established and began its work in 2018. Consequently, publications from 2013 to 2018 are included in this guideline.

The guideline group comprises representatives from current AWMF societies who also are members of the advisory board of the German Pain Society, ensuring a close connection to the topic of this guideline. The authors aim to optimize the treatment of patients with chronic pain and provide a rational foundation for medical decisions in the care of individuals with chronic pain.

## MATERIALS AND METHODS

To identify the relevant literature through a systematic selection and combination of search terms, the Guideline Committee formulated clinically relevant questions based on the PatientIntervention-Comparison-Outcome (PICO) framework. The resulting questions were organized into the following categories:

1. pathophysiology and underlying mechanism of SCS, and basic science; 2. indications; 3. methods and techniques of DRG-S and SCS; 4. complications and quality assessment; and 5. psychologic outcome and predictors.

The PICO questions led to the development of search terms, including 1) terms related to the health condition of interest, 2) terms for the evaluated intervention(s), and 3) terms for the types of study design. These terms were used to search the Cochrane Database, PubMed, and EMBASE for relevant literature (last date for search: September 4, 2019). After stratifying the publications according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, 6 they were categorized into the fi ve topics (as outlined above), with each topic being reviewed and edited by two to three authors. Randomized controlled trials (RCTs) involving larger cohorts were prioritized in the evaluation. Individual case reports were included only if they provided clinically relevant insights.

Considering other international and national guidelines, the ranking scheme of the Oxford Centre of Evidence-based Medicine was used ( https://www.cebm.ox.ac.uk/resources/levels-ofevidence/ocebm-levels-of-evidence ) ( Table 1 ). After an initial evidence assessment by the authors, the fi nal evaluation was conducted collaboratively during four consensus conferences with

Table 1. Level of Recommendation and the Corresponding Hierarchy of Evidence.

|Level of| Level of evidence |Type of literature| |---|---|---| |recommendation| Level of evidence || ||1a| Systematic review of RCTs ≥1 RCT | ||10|| |3|2a—b| Systematic review of comparative cohort studies | ||3a—b|Systematic review of either| ||| case-control studies or ≥1 well designed control study | |||Case series and inadequate| ||| case-control studies, reasonable expert opinion | ||| Opinions without explicit critical evaluation |

Level of recommendation and the corresponding hierarchy of evidence were determined according to the type of publication (diagnostic studies and therapy studies, respectively). Level of recommendation: A, strong recommendation; B, recommendation; O, recommendation indecisive. Adapted from https://www.cebm.ox.ac.uk/resources/levels-of-evidence/ ocebm-levels-of-evidence .

Table 2. Is There Evidence for SCS and/or DRG-S in Diabetic Neuropathic Pain Conditions?

||Recommendation|| |---|---|---| |Grade A||| || dorsal spinal ganglion stimulation should be offered || |Evidence|Level 2|| ||Consensus: 100%|| |||| |||| | neuralgia, avulsions. |||

Table 3. What is the Evidence for SCS and DRG-S for PSPS and Chronic Lower Back Pain?

||Recommendation| |---|---| | grade a)A |SCS should be used for postoperative back/leg pain for PSPS || ||and II. DRG-S can be helpful in individual cases.| |b)O|| || Evidence a) Level 1 for SCS for lumbar back pain and/or postoperative back-leg pain in the context of psps.18-20 | ||b Level 4 for DRG-s for back pain in the context of PSP.21| |SCS is the best treatment for PSPS not responding to other conservative or||

| Table 4. Is SCS Recommended for Treatment-Refractory Angina Pectoris? || |---|---| ||Recommendation| |grade|SCS should be offered for treatment-refractory angina| ||| ||22.23| ||Consensus: 100%|

Table 5. At What Level of Peripheral Vascular Disease is SCS Effective?

Recommendation Grade SCS should be used for peripheral arterial vascular disease. A Evidence Level 1 for grade 2b and 3 (Fontaine classi fi cation) (The RASCAL [Refractory Angina Spinal Cord Stimulation and UsualCare] study, https://doi.org/10.1186/ISRCTN65254102 ), 24 Consensus: 100%

Table 6. Is There a Frequency Dependency in SCS in the Treatment of Chronic Pain?

Recommendation Grade A In the test phase of SCS/DRG-S, different frequencies should be tested. External testing of the therapy effect after electrode implantation is necessary. Evidence Level 1 evidence that different frequencies have different therapeutic effects Level 4: for the comparison of therapies Level 4: for predictors 25 – 28 Consensus: > 75%

Table 7. Is There a Dependency of the Stimulation Paradigms on the Effectiveness?

Recommendation Grade Various waveforms (including high-frequency paradigms) are B to be tested at SCS. Evidence Level 2 25 – 27 Consensus: $100\%$

Table 8. Chronic Regional Pain Syndrome (CRPS): Is DRG-S for CRPS Superior to SCS?

Recommendation Grade DRG-S should be used for CRPS. Early treatment is important A ( > six months after diagnosis). Evidence Level 2 for DRG 29 , 30 Level 4 for SCS Consensus: > 75% SCS for CRPS can alternatively be used, especially at the upper extremity. 18 , 31

Table 9. CRPS of the Lower Extremity, Effectiveness of DRG-S and SCS.

Recommendation

Grade DRG-S should be used for the treatment of CRPS type I A and II of the lower extremities. Evidence Level 1 for DRG-S for CRPS I and II 29 , 30 Level 2 for DRG-S and level 4 for SCS for focal neuropathic pain 31 Consensus: 100%

For safety reasons, further studies are required to con fi rm the use of DRG-S of the upper extremity for the treatment of CRPS. SCS, however, is effective for focal neuropathic pain of both the upper and lower extremity (The PENTAGONS trial, https://doi.org/10.1186/ISRCTN40062191 ). 18 , 31

EPIDURAL SCS IN CHRONIC PAIN

Recommendation Grade Regarding discontinuing anticoagulant medications, before A performing an intervention, an individual bene fi t-risk assessment should be conducted. Evidence Level 1 30 , 32 Consensus: $100\%$

Table 11. How Common Are Intraspinal Hematomas in DRG-S?

Recommendation Grade Preoperative discontinuation of anticoagulant medication A should occur. Evidence Level $2^{32}$ Consensus: $100\%$

Intraspinal hematomas in DRG-S are very uncommon.

Table 12. Is Cerebrospinal Fluid (CSF) Fistula a Common Complication of SCS or DRG-S?

Grade Intraoperative CSF puncture should be avoided. A Evidence Level 2 33 – 35 Consensus: 100%

The occurrence of a persistent CSF fi stula is reported in the literature as up to $0.3\%$ the occurrence of an intraoperative CSF puncture is described as up to $1\uparrow\%$ . Punctures of the CSF space are more frequent in DRG-S than in SCS, owing to different access to the spinal canal.

Table 13. How Frequent Are Mechanical Complications, and How Frequent Are Relevant Medical Consequences (Electrode Fractures and Dislocations, Pain on the Internal Pulse Generator [IPG], Foreign Body Sensation)?

Recommendation

Grade Mechanical complications are common (up to $40\%,$ ). A Evidence Level 1 36 , 37 Consensus: 100%

Most of the reported mechanical complications are electrode fractures and dislocations, pain at the IPG, and foreign body sensation. Improvements, especially in the anchoring of the electrodes, are important. Extensive results are available from consensus conferences, systematic reviews, and multicenter prospective studies.

Table 10. How Frequent are Spinal Hematomas in SCS?

Table 14. How Common Are Implant-related Infections?

||Recommendation| |---|---| |grade| Implant-related infections occur with a frequency of 3%- 6%3 | ||| |Evidence|level 1| ||Consensus: 10o%| |An implant infection occurs in 3% to 6% of cases (in the literature, SCS up|| |to 14%, lower for DRG-S). To avoid infections, patients should be operated||

|| Table 15. Does Spinal Neuromodulation Improve Patients’ Quality of Life Compared with Conservative Therapy Alone Preoperatively? | |---|---| || Table 15. Does Spinal Neuromodulation Improve Patients’ Quality of Life Compared with Conservative Therapy Alone Preoperatively? | ||Statement| |grade|SCS sustainably improves the quality of life and the| ||psychologic outcome of patients, in addition to| || the quality of life (Qol) and 36-ltem Short Form Survey score.338 | ||This also applies to the DRG-s.39 There also are significant| ||improvements in the Oswestry Disability Index,| ||European QoL, and Patient Global Impression| ||of Change.| |Evidence|Level 2| ||Consensus: 100%|

Table 16. Should Patients Undergo a Structured Psychologic Assessment as Part of the Spinal Neuromodulation Eligibility Check?

||Recommendation| |---|---| |grade|A psychologic assessment should always be performed| ||preoperatively.| |Evidence|Level 241- 4| ||Consensus: 100%| ||| |multimodal, interdisciplinary assessment.||

representatives from relevant German medical societies, who had expressed interest in contributing beforehand. Recommendations were developed during these meetings.

The guideline aims to optimize the treatment of patients with chronic pain, for whom neuromodulation may be an integral component of a multimodal pain management strategy. Critical to the success of this therapy are careful patient selection and adherence to diagnostic and therapeutic algorithms, both before and after treatment. The guideline must not only re fl ect the personal experience of its developers but also incorporate the most thorough and critical evaluation of the available international literature. The evidence base is a crucial element and combined with an interdisciplinary approach, serves as a prerequisite for widespread acceptance. The aim of the guideline is to disseminate evidence-based recommendations that provide a rational foundation for decision-making in the medical care of individuals with speci fi c chronic pain conditions.

Owing to the pandemic, the members of the guideline commission involved in the previous S3 guideline were unable to meet in person and instead held online meetings through MS Teams and Zoom between August 2021 and November 2022. During these meetings, the relevant literature was reviewed and incorporated into the existing guideline with appropriate recommendations. The structure of the initial guideline from 2013 was adopted to facilitate comparison for the user. In accordance with AWMF recommendations, the intention was to evaluate the literature using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. However, it became evident that we could not recruit enough independent authors without con fl icts of interest for the evaluation process. Moreover, the GRADE system requires

end point prioritization, which was not performed. As a result, we reverted to the original Oxford classi fi cation.

RESULTS

A total of 32 guideline recommendations and statements regarding SCS/DRG-S have been established. The voting process was blinded. In cases when authors had a real or perceived con fl ict of interest, their votes were excluded, and the voting process was repeated without their participation. No differences were observed in any statement or recommendation. The most important recommendations and statements are presented below ( Tables 2 – 16 ). 4 , 7 – 44

DISCUSSION

Our search for guideline statements and recommendations identi fi ed 2127 manuscripts. After applying PRISMA-based exclusion criteria, 550 articles were reviewed, of which 150 met the criteria for the recommendation process. Each of these studies addressed a speci fi c condition, a method, or outcome data.

In a recently published manuscript offering a comprehensive analysis of SCS for chronic neuropathic pain treatment, Huygen et al 45 provided an excellent summary of the relevant literature from recent years, covering topics such as indications, costeffectiveness, and QoL. The review addressed key questions regarding outcomes, effectiveness, and safety and included information on complications and emerging indications suchVIEW as CRPS. Therefore, it is an excellent completion to our guideline. Accordingly, we established the following recommendations:

1. Is there evidence for SCS/DRG-S for diabetic polyneuropathy (dPNP)? For other neuropathic pain, only small case studies are available with positive results. These include postherpetic neuralgia, 14 phantom or stump pain, 15 pain with incomplete transverse spinal cord injury, 16 and plexus lesions. 17 A level 2 recommendation for dPNP is given with low evidence for polyneuropathy of other origin. DRG stimulation can be effective in dPNP, but only a few studies have been published so far. 12 Given there is evidence for the effectiveness of SCS in that indication, the use of DRG-S instead of SCS must be individually justi fi ed. 2. SCS received a level 1 recommendation for lumbar back pain and/or for postoperative back and leg pain for persistent spinal pain syndrome (PSPS) I and II. DRG-S can be helpful in individual cases. 3. There is new evidence for SCS in therapy-refractory angina pectoris. It is advisable to use it (level 1). 4. Level 1 recommendation was found for peripheral vascular disease with grade 2b and 3, according to Fontaine. 5. SCS is helpful in selected patients with CRPS. SCS only received a level 4 recommendation. However, there is more evidence for DRG-S. The authors de fi ned a level 2 recommendation for CRPS I and II. Furthermore, DRG-S is superior to low-frequency tonic SCS. DRG stimulation should be considered as an effective treatment for CRPS I and II of the lower extremities.

The updated guideline aims to present the latest evidence-based fi ndings on epidural SCS, including spinal ganglia stimulation, for the treatment of both neuropathic and nonneuropathic pain. Because of advances in interdisciplinary therapy and numerous technical innovations in chronic pain treatment, an update to the S3 guideline established in 2013 became mandatory. This guideline, initially completed in April 2013, required revision after two years of implementation.

The expansion of the professional societies involved, particularly the German Society for Psychosomatic Medicine and Medical Psychotherapy, along with the numerous publications that have since emerged in this fi eld, prompted an update particularly in terms of content. The high prevalence and incidence of chronic pain, particularly neuropathic pain, along with established recommendations for pharmacologic treatment underscore the urgent need for an evaluation of cost-intensive invasive procedures in terms of their evidence within the broader framework of multimodal pain therapy.

In addition to considering other international and national guidelines, the recommendations from the Oxford Centre of Evidence-based Medicine were used. After an initial evaluation of the evidence by experienced authors using the 2011 Oxford classi fi cation ( https://www.cebm.ox.ac.uk/resources/levels-of-evidence/ ocebm-levels-of-evidence ) and preliminary discussions in working groups, the evidence evaluation was conducted centrally by guideline experts.

Limitations

Although this guideline offers an overview of the recent evidence regarding new technologies, indications, effectiveness, and complications for SCS and DRG-S, it has limitations, which must be considered. Owing to the extensive restrictions imposed by the COVID-19 pandemic, the revision of the guideline lasted much longer than previously considered. The incorporated references are limited to the end of 2018. Some new RCTs have since been published. Those were included if they affected any statements of the guideline. Furthermore, most of the authors (active practitioners in neuromodulation) were partially biased. A double voting process for each question (with and without the authors with con fl icts of interest) was performed to exclude signi fi cant in fl uence on the recommendation. The impact of any guideline is limited to a certain period. Although the current version offers a comprehensive overview of the present techniques and indications for SCS compared with the previous version from 2013, there is a need for a periodic update. A new update is already in progress and will be implemented as soon as possible, considering recent developments and indications in the fi eld of neuromodulation (eg, spinal cord injury and extraspinal stimulation). Highly experienced colleagues have been recruited as coordinators, and submission publication is planned for 2025. For this, new chapters also will be included discussing explant rates, long-term outcome, better indicators for QoL, closed-loop stimulation, mechanical complications, and remote programming.

CONCLUSIONS

The broader adoption of neuromodulation, particularly SCS, relies on the systematic collection and publication of outcome

data, with real-world evidence playing a crucial role. This is especially important in the current climate, in which fundamental questions about the value of SCS are being debated publicly, often in nonscienti fi c forums. Publishing systematic evidence-based guidelines at both national and international levels is essential to provide reliable information for clinicians, payers, and most importantly, patients. In addition, both national and international implant registries offer a valuable tool for gathering data, more ef fi ciently enabling the development of future recommendations.

Acknowledgements

The authors are indebted to Dr Monika Nothacker for moderating the process and Dr Marie Metzendorf, MD, Cochrane Institute, for Preferred Reporting Items for Systematic Reviews and MetaAnalyses processing; Guideline secretaries Dr Juliane Weski and Ms Andrea Dreyer, RN; Dr Anastasiya Schubert for manuscript proofreading; and to the Guideline Committee: Dr Jan Vesper, Dr Philipp Joerg Slotty, Dr Dirk Rasche, Dr Rezvan Ahmadi, Dr Martin Jakobs, Dr Bjoern Carsten Schultheis, Dr Michael Kretzschmar, Dr Sebastian Gillner, and Dr Jaroslaw Macziacyk. The authors also thank the coauthors of participating German medical societies:

• German Society for Neurology • Interdisciplinary Society for Orthopaedic/Trauma Surgery and General Pain Therapy • German Society for Psychosomatic Medicine and Psychotherapy • Professional Association of Physicians and Psychological Psy chotherapists in Pain and Palliative Medicine in Germany • German Spine Society • UVSD SchmerzLOS e.V. (patient association for pain)

Guideline Committee and secretaries: Jan Vesper, MD, PhD; Björn Carsten Schultheis, MD; Philipp Joerg Slotty, MD, PhD; Michael Kretzschmar, MD; Rezvan Ahmadi, MD, PhD; Martin Jakobs, MD; Jaroslaw Maciaczyk, MD, PhD; Dirk Rasche, MD, PhD; Andrea Dreyer, RN; Juliane Weski, PhD.

Authorship Statements

The guideline committee developed the recommendations under the leadership of Jan Vesper. Jan Vesper and Philipp Joerg Slotty prepared the manuscript draft with important intellectual input from Juliane Weski. The German chapter of Neuromodulation provided funding for the guideline.

Con fl ict of Interest

Jan Vesper reports consulting income from Abbott and Boston Scienti fi c and honoraria for speaking engagements from Abbott, Medtronic, and Boston Scienti fi c; support for attending meetings from Abbott, Boston Scienti fi c, and Medtronic; and participation on an advisory board for Abbott and Uniqure. Philipp Joerg Slotty reports consulting income and honoraria for speaking engagements from Abbott and Boston Scienti fi c, and support for attending meetings from Abbott, Boston Scienti fi c, Saluda Medical, United States, medical communication (BSH). Juliane Weski reports no con fl ict of interest.

How to Cite This Article

Vesper J., Weski J., Slotty P.J. 2025. German National Guidelines for Epidural Spinal Cord Stimulation for the Treatment of Chronic Pain. Neuromodulation 2025; - : 1 – 7.

REFERENCES

1. Cohen SP, Vase L, Hooten WM. Chronic pain: an update on burden, best practices, and new advances. Lancet . 2021;397:2082 – 2097 . 2. Stubhaug A, Hansen JL, Hallberg S, Gustavsson A, Eggen AE, Nielsen CS. The costs of chronic pain-Long-term estimates. Eur J Pain . 2024;28:960 – 977 . 3. Finnerup NB, Otto M, McQuay HJ, Jensen TS, Sindrup SH. Algorithm for neuropathic pain treatment: an evidence based proposal. Pain . 2005;118:289 – 305 . 4. Attal N, Cruccu G, Haanpää M, et al. EFNS guidelines on pharmacological treatment of neuropathic pain. Eur J Neurol . 2006;13:1153 – 1169 . 5. Dworkin RH, O ’ Connor AB, Backonja M, et al. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain . 2007;132:237 – 251 . 6. Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med . 2009;6:e1000097 . 7. de Vos CC, Bom MJ, Vanneste S, Lenders MWPM, de Ridder D. Burst spinal cord stimulation evaluated in patients with failed back surgery syndrome and painful diabetic neuropathy. Neuromodulation . 2014;17:152 – 159 . 8. de Vos CC, Meier K, Zaalberg PB, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: a multicentre randomized clinical trial. Pain . 2014;155:2426 – 2431 . 9. van Beek M, Slangen R, Schaper NC, et al. Sustained treatment effect of spinal cord stimulation in painful diabetic peripheral neuropathy: 24-month follow-up of a prospective two-center randomized controlled trial. Diabetes Care . 2015;38:e132 – e134 . 10. Tesfaye S, Watt J, Benbow SJ, Pang KA, Miles J, MacFarlane IA. Electrical spinal-cord stimulation for painful diabetic peripheral neuropathy. Lancet . 1996;348:1698 – 1701 . 11. Petrakis IE, Sciacca V. Does autonomic neuropathy in fl uence spinal cord stimulation therapy success in diabetic patients with critical lower limb ischemia? Surg Neurol . 2000;53:182 – 188 [discussion 188 – 189] . 12. Cruccu G. Treatment of painful neuropathy. Curr Opin Neurol . 2007;20:531 – 535 . 13. Petersen EA, Stauss TG, Scowcroft JA, et al. Durability of high-frequency 10-kHz spinal cord stimulation for patients with painful diabetic neuropathy refractory to conventional treatments: 12-month results from a randomized controlled trial. Diabetes Care . 2022;45:e3 – e6 . 14. Harke H, Gretenkort P, Ladleif HU, Koester P, Rahman S. Spinal cord stimulation in postherpetic neuralgia and in acute herpes zoster pain. Anesth Analg . 2002;94:694 – 700 . 15. Sánchez-Ledesma MJ, García-March G, Diaz-Cascajo P, Gómez-Moreta J, Broseta J. Spinal cord stimulation in deafferentation pain. Stereotact Funct Neurosurg . 1989;53:40 – 45 . 16. Winkelmüller W. Spinal neurostimulation for the treatment of chronic pain: changes in indications and patient selection after 19 years ’ experience. Schmerz . 1991;5:243 – 246 . 17. Ilfeld BM, Plunkett A, Vijjeswarapu AM, et al. Percutaneous neuromodulation of the brachial plexus and sciatic nerve for the treatment of acute pain following surgery: secondary outcomes from a multicenter, randomized, controlled pilot study. Neuromodulation . 2023;26:638 – 649 . 18. Colombo EV, Mandelli C, Mortini P, et al. Epidural spinal cord stimulation for neuropathic pain: a neurosurgical multicentric Italian data collection and analysis. Acta Neurochir (Wien) . 2015;157:711 – 720 . 19. Deckers K, De Smedt K, Mitchell B, et al. New therapy for refractory chronic mechanical low back pain-restorative neurostimulation to activate the lumbar multi fi dus: one year results of a prospective multicenter clinical trial. Neuromodulation . 2018;21:48 – 55 . 20. Deer T, Pope J, Hayek S, et al. Neurostimulation for the treatment of axial back pain: a review of mechanisms, techniques, outcomes, and future advances. Neuromodulation . 2014;17(suppl 2):52 – 68 . 21. Kallewaard JW, Edelbroek C, Terheggen M, Raza A, Geurts JW. A prospective study of dorsal root ganglion stimulation for non-operated discogenic low back pain. Neuromodulation . 2020;23:196 – 202 . 22. Imran TF, Malapero R, Qavi AH, et al. Ef fi cacy of spinal cord stimulation as an adjunct therapy for chronic refractory angina pectoris. Int J Cardiol . 2017;227:535 – 542 . 23. Pan X, Bao H, Si Y, et al. Spinal cord stimulation for refractory angina pectoris: a systematic review and meta-analysis. Clin J Pain . 2017;33:543 – 551 . 24. De Caridi G, Massara M, David A, et al. Spinal cord stimulation to achieve wound healing in a primary lower limb critical ischaemia referral centre. Int Wound J . 2016;13:220 – 225 . 25. Kapural L, Peterson E, Provenzano DA, Staats P. Clinical evidence for spinal cord stimulation for failed back surgery syndrome (FBSS): systematic review. Spine . 2017;42(suppl 14):S61 – S66 . 26. Perruchoud C, Eldabe S, Batterham AM, et al. Analgesic ef fi cacy of high-frequency spinal cord stimulation: a randomized double-blind placebo-controlled study. Neuromodulation . 2013;16:363 – 369 [discussion 369] . 27. Thomson SJ, Tavakkolizadeh M, Love-Jones S, et al. Effects of rate on analgesia in kilohertz frequency spinal cord stimulation: results of the PROCO randomized controlled trial. Neuromodulation . 2018;21:67 – 76 . 28. Vesper J, Slotty P, Schu S, et al. Burst SCS microdosing is as ef fi cacious as standard burst SCS in treating chronic back and leg pain: results from a randomized controlled trial. Neuromodulation . 2019;22:190 – 193 . 29. Bruehl S. Complex regional pain syndrome. BMJ . 2015;351:h2730 . 30. Deer TR, Levy RM, Kramer J, et al. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain . 2017;158:669 – 681 . 31. Kemler MA, de Vet HCW, Barendse GAM, van den Wildenberg FAJM, van Kleef M. Spinal cord stimulation for chronic re fl ex sympathetic dystrophy – fi ve-year followup. N Engl J Med . 2006;354:2394 – 2396 . 32. Deer TR, Lamer TJ, Pope JE, et al. The Neurostimulation Appropriateness Consensus Committee (NACC) safety guidelines for the reduction of severe neurological injury. Neuromodulation . 2017;20:15 – 30 . 33. Eldabe S, Buchser E, Duarte RV. Complications of spinal cord stimulation and peripheral nerve stimulation techniques: a review of the literature. Pain Med . 2016;17:325 – 336 . 34. Liem L, Russo M, Huygen FJPM, et al. A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. Neuromodulation . 2013;16:471 – 482 [discussion 482] . 35. Cruccu G, Garcia-Larrea L, Hansson P, et al. EAN guidelines on central neurostimulation therapy in chronic pain conditions. Eur J Neurol . 2016;23:1489 – 1499 . 36. Deer TR, Pope JE, Lamer TJ, et al. The neuromodulation appropriateness consensus committee on best practices for dorsal root ganglion stimulation. Neuromodulation . 2019;22:1 – 35 . 37. Practice advisory for the prevention, diagnosis, and management of infectious complications associated with neuraxial techniques: an updated report by the American society of anesthesiologists task force on infectious complications associated with neuraxial techniques and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology . 2017;126:585 – 601 . 38. Campos WK, Linhares MN, Sarda J, et al. Determinants for meaningful clinical improvement of pain and health-related quality of life after spinal cord stimulation for chronic intractable pain. Neuromodulation . 2019;22:280 – 289 . 39. Huygen FJPM, Liem L, Nijhuis H, Cusack W, Kramer J. Evaluating dorsal root ganglion stimulation in a prospective Dutch cohort. Neuromodulation . 2019;22:80 – 86 . 40. Rigoard P, Desai MJ, North RB, et al. Spinal cord stimulation for predominant low back pain in failed back surgery syndrome: study protocol for an international multicenter randomized controlled trial (PROMISE study). Trials . 2013;14:376 . 41. Paroli M, Bernini O, De Carolis G, et al. Are multidimensional pain inventory coping strategy pro fi les associated with long-term spinal cord stimulation effectiveness? Pain Med . 2018;19:1023 – 1032 . 42. Prabhala T, Kumar V, Gruenthal E, et al. Use of a psychological evaluation tool as a predictor of spinal cord stimulation outcomes. Neuromodulation . 2019;22:194 – 199 . 43. Blackburn DR, Romers CC, Copeland LA, et al. Presurgical psychological assessments as correlates of effectiveness of spinal cord stimulation for chronic pain reduction. Neuromodulation . 2016;19:422 – 428 . 44. Fama CA, Chen N, Prusik J, et al. The use of preoperative psychological evaluations to predict spinal cord stimulation success: our experience and a review of the literature. Neuromodulation . 2016;19:429 – 436 . 45. Huygen FJPM, Soulanis K, Rtveladze K, Kamra S, Schlueter M. Spinal cord stimulation vs medical management for chronic back and leg pain: a systematic review and network meta-analysis. JAMA Netw Open . 2024;7:e2444608 .

COMMENTS

Each clinician practicing SCS for their patients has an obligation to be up to date with the primary literature. In that sense, if that outcome were universal, guidelines might not serve a critically important role. However, even in that scenario, the interpretation of the literature would be very heterogenous and so would clinical care. That is where guidelines come in: to support homogeneity of data collation and interpretation, and to provide nonpractitioners (healthcare systems, governments, etc) with clarity concerning what the literature does say, does not say, and cannot say. This review ful fi ls that need.

National guidelines serve national healthcare needs and may not be directly translatable to other systems — bear that in mind as you read this article. Moreover, of course, any guideline is locked in time and

slowly has a decay half-life as time marches on and new information comes to hand. All guidelines ultimately expire and must be renewed.

The process of contributing to guideline development is scienti fi - cally invigorating. I encourage all to consider ways they may contribute to their local, regional, or national consensus documents; they will be better doctors for it.

Marc Russo, MBBS Broadmeadow, New South Wales, Australia

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The authors present a very nice overview from Germany. In times of reductions of reimbursement, these kinds of articles are extremely important.

EPIDURAL SCS IN CHRONIC PAIN

Martine Puylaert, MD Genk, Belgium

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Recently, questions have been raised about the robustness of the evidence regarding the effects of SCS for treating chronic pain. In light of this debate, evidence-based guidelines and registries for SCS and DRG-S are essential to strengthen the evidence for neuromodulation technology in pain treatment at both the national and international level. The updated German National Guidelines provide important information for clinicians, payers, and patients about the value of SCS and DRG-S in this context.

Kliment Gatzinsky, MD, PhD Gothenburg, Sweden

© 2025 The Authors. Published by Elsevier Inc. on behalf of the International Neuromodulation Society. This is an open access article under the CC BY-NC license ( http://creativecommons.org/licenses/by-nc/4.0/ ).