Article Text
Abstract
Background/importance Patient selection for spinal cord stimulation (SCS) therapy is crucial and is traditionally performed with clinical selection followed by a screening trial. The factors influencing patient selection and the importance of trialing have not been systematically evaluated.
Objective We report a narrative review conducted to synthesize evidence regarding patient selection and the role of SCS trials.
Evidence review Medline, EMBASE and Cochrane databases were searched for reports (any design) of SCS in adult patients, from their inception until March 30, 2022. Study selection and data extraction were carried out using DistillerSR. Data were organized into tables and narrative summaries, categorized by study design. Importance of patient variables and trialing was considered by looking at their influence on the long-term therapy success.
Findings Among 7321 citations, 201 reports consisting of 60 systematic reviews, 36 randomized controlled trials (RCTs), 41 observational studies (OSs), 51 registry-based reports, and 13 case reports on complications during trialing were included. Based on RCTs and OSs, the median trial success rate was 72% and 82%, and therapy success was 65% and 61% at 12 months, respectively. Although several psychological and non-psychological determinants have been investigated, studies do not report a consistent approach to patient selection. Among psychological factors, untreated depression was associated with poor long-term outcomes, but the effect of others was inconsistent. Most RCTs except for chronic angina involved trialing and only one RCT compared patient selection with or without trial. The median (range) trial duration was 10 (0–30) and 7 (0–56) days among RCTs and OSs, respectively.
Conclusions Due to lack of a consistent approach to identify responders for SCS therapy, trialing complements patient selection to exclude patients who do not find the therapy helpful and/or intolerant of the SCS system. However, more rigorous and large studies are necessary to better evaluate its role.
- Spinal Cord Stimulation
- analgesia
- Back Pain
- CHRONIC PAIN
- Complex Regional Pain Syndromes
Statistics from Altmetric.com
Footnotes
Twitter @harshamd5, @jonhagedornmd, @NarouzeMD
Contributors HS is the steering committee lead of ASRA SCS patient selection and trial guidelines, made the original concept and plan, supervised the study conduct and drafted the content of the manuscript. YC participated in study selection, data extraction, conduct and writing of the review. DA participated in study selection, data extraction, conduct and writing of the review. IK participated in study selection, data extraction, conduct and writing of the review. AG participated in study selection, data extraction, conduct and writing of the review. CT participated in study selection, data extraction, conduct and writing of the review. RJC is a senior librarian who participated in the comprehensive search and cataloging studies and organizing within Distiller. TL participated in study selection, data extraction, conduct and writing of the review. JMH is the content expert, who contributed to manuscript draft writing and revisions. SE is a steering committee member of ASRA SCS patient selection and trial guidelines and content expert, who contributed to study idea and manuscript draft writing and revisions. DAP is a steering committee member of ASRA SCS patient selection and trial guidelines and content expert, who contributed to study idea and manuscript draft writing and revisions. SN is a steering committee member of ASRA SCS patient selection and trial guidelines and content expert, who contributed to study idea and manuscript draft writing and revisions.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests SN and DAP are editors for RAPM. All other authors declare no conflicts of interest.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.