Advancing towards international practice guidelines in interventional pain medicine

In the current issue of Interventional Pain Medicine, Klessinger and colleagues published“Time to standardize: The German Spine Society national clinical guideline on epidural injections.” We commend the authors and the working group for their effort to standardize the practice of epidural steroid injections in a setting where interventional spine care is still evolving. This guideline represents an important step toward a shared vocabulary, safer technique, and more consistent, evidence-informed decision-making in epidural injection practice in the authors’ region.

 

Epidural steroid injections were first described in the late nineteenth century, with early work attributed to neurologist James Leonard Corning. Since that time, they have become among the most commonly performed interventional pain procedures worldwide, particularly in the United States. The scientific knowledge base surrounding epidural steroid injections has expanded substantially. A search of the PubMed database demonstrates that since 1980 alone, more than 4000 publications related to epidural steroid injections have addressed a broad range of topics, including technical approaches, injectate composition, safety considerations, and clinical efficacy.

Despite this extensive literature, practice patterns remain highly variable. Professional societies have published guidelines on epidural steroid injections, but these recommendations are often limited in scope, frequently focused on safety concerns or specific indications, and are shaped by heterogeneous and sometimes conflicting data. Even in regions with well-established interventional pain medicine infrastructure, substantial variation persists in technique, medication selection, terminology, and utilization. In this context, a comprehensive, evidence-based, and broadly agreed-upon guideline has the potential to significantly improve communication among clinicians, researchers, payers, and patients.

 

Klessinger and colleagues appropriately highlight many of the challenges inherent in developing such guidance. Ongoing variability in procedural technique, injectate choice, and even basic nomenclature underscores the need for consensus-driven standardization. We therefore particularly commend the authors for their effort. The authors tried to achieve methodological rigor during the guideline development process. The structured evidence appraisal using GRADE methodology, external evaluation with AGREE II, and multidisciplinary authorship, including patient representatives, are notable strengths. The use of a modified Delphi process with both internal and external review further enhances transparency and credibility. In many clinical environments, “standard practice” continues to be shaped by apprenticeship models and local custom rather than systematically synthesized evidence. It's only by national and international efforts like this one where changes can be made.

 

While we applaud the authors' efforts, we disagree with certain aspects of the guideline. Based on the paper's supplemental material, it is evident that the authors of the guidelines considered only randomized control trials (RCTs) in their analysis. By excluding observational studies, systematic reviews may inadvertently endorse findings from poorly designed RCTs. In contrast, observational studies reflect real-world scenarios. They are not limited to patients who agree to be randomized and who present with singular, specific pain issues. Observational studies establish benchmarks for the expected outcomes in clinical practice. We should be cautious about allowing RCTs to overturn established practices based on well-designed, well-conducted prospective observational studies, as these can provide valuable evidence.

 

The GRADE criteria can and should be applied in such a way that observational studies may be upgraded for factors such as large effect sizes or dose-response gradients, or when confounding factors are likely to diminish an apparent effect—thereby boosting confidence in these findings. Conversely, RCTs should be downgraded for issues such as poor blinding or selective reporting, which can undermine their inherent validity. We believe that the strength of clinical guidelines will be significantly enhanced if all evidence, not restricted solely to RCTs, is considered in the analysis.

Ultimately, efforts such as this guideline should be viewed as a foundation rather than an endpoint. While current efforts such as this one are laudable for providing a framework that guides clinical practice, the clinical questions these and many other guidelines address simultaneously highlight the vast areas of growth our field would greatly benefit from. Defining aspects of the procedure still largely focuses on simply ensuring the injectate reaches the target structure. Indications are still bluntly defined as radicular pain. Procedural specific recommendations broadly recommend elementary compulsory skill sets such as utilizing image guidance. Detailed recommendations are limited in scope to isolated nuance, such as only using dexamethasone for cervical transforaminal epidural steroid injections or limiting cervical interlaminar epidural steroid injections to C6-7 and below. Other important consensus recommendations, such as not repeating the same injection until the effect of a first treatment is evaluated, are warranted but at the same time seem rudimentary. This guideline, as with many others, suffer from the same dearth of well performed, valid, and impactful research. As medicine in general is trending towards patient specific precision-based medicine, interventional research must strive to do the same.

 

Ideally, future guidelines will be better equipped with literature to provide clear and precise recommendations with far greater granularity than is currently possible. Our field, in general, is behooved to progress towards having a greater understanding of variables that are predictive of positive and negative outcomes, technical factors that not only focus on preventing complications but also improve effectiveness, and cost-effectiveness. The reality is that despite the advancements seen in the last 25 years, our field is still trying to generate consistency across practices in an effort to introduce uniformity. This step, while exceedingly important, is well short of having a unified field collectively pushing towards defined and precise targets of substantial progress.

 

Continued progress will require a coordinated strategy to strengthen the evidence base needed to support cost-effective, patient-centered clinical guidance. This includes well-designed randomized trials comparing techniques, injectates, dosing strategies, and treatment intervals using standardized, clinically meaningful outcomes with adequate long-term follow-up. In parallel, pragmatic implementation studies are needed to evaluate feasibility, adherence, resource utilization, and real-world effectiveness across diverse practice settings, ideally incorporating cost-effectiveness analyses. The development of prospective outcome registries capturing procedural details, complications, repeat interventions, and patient-reported outcomes would further enable comparative effectiveness research and iterative refinement of recommendations. Together, these efforts can transform geographically based, consensus-driven guidance into a dynamic, evidence-based framework with relevance across healthcare systems, improving quality, consistency, safety, and value of care for patients worldwide.