Dawood Sayed,1 Timothy R Deer,2,3 Vinicius Tieppo Francio,1 Christopher M Lam,1 Kamil Sochacki,4 Nasir Hussain,5 Tristan E Weaver,5 Jay Karri,6,7 Vwaire Orhurhu,8,9 Natalie Holmes Strand,10 Jacqueline Soicher Weisbein,11 Jonathan M Hagedorn,12 Ryan S D’Souza,12 Ryan R Budwany,2 Ahish Chitneni,13 Kasra Amirdelfan,14 Michael J Dorsi,15 Dan TD Nguyen,16 Christopher Bovinet,17 Alaa Abd-Elsayed18

1Anesthesiology and Pain Medicine, The University of Kansas Medical Center, Kansas City, KS, USA; 2Pain Services, Spine and Nerve Center of the Virginias, Charleston, WV, USA; 3Anesthesiology and Pain Medicine, West Virginia University School of Medicine, Charleston, WV, USA; 4Department of Anesthesiology and Perioperative Medicine, Rutgers Robert Wood Johnson, New Brunswick, NJ, USA; 5Anesthesiology, the Ohio State University Wexner Medical Center, Columbus, OH, USA; 6Department of Orthopedic Surgery, University of Maryland School of Medicine, Baltimore, MD, USA; 7Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD, USA; 8Department of Anesthesiology, University of Pittsburgh Medical Center, Williamsport, PA, USA; 9Pain Medicine, MVM Health, East Stroudsburg, PA, USA; 10Anesthesiology and Pain Medicine, Mayo Clinic, Phoenix, AZ, USA; 11Interventional Pain Management, Napa Valley Orthopaedic Medical Group, Napa, CA, USA; 12Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA; 13Department of Rehabilitation & Regenerative Medicine, New York Presbyterian – Columbia & Cornell, New York, NY, USA; 14Director of Clinical Research, Boomerang Healthcare, Walnut Creek, CA, USA; 15Neurosurgery, University of California Los Angeles, Los Angeles, CA, USA; 16Neuroradiology & Pain Solutions of Oklahoma, Edmond, OK, USA; 17The Spine Center of SE Georgia, Brunswick, GA, USA; 18Anesthesiology, University of Wisconsin, Madison, WI, USA

Correspondence: Dawood Sayed, Anesthesiology and Pain Medicine, The University of Kansas Medical Center, Kansas City, KS, USA, Tel +1 785-550-5800, Email [email protected]

View the original paper by Dr Sayed and colleagues

This is in response to the Letter to the Editor

On behalf of the authorship of the ASPN Best Practice Guideline for the Treatment of Sacroiliac Disorders, we appreciate the interest in our recently published manuscript. We, however, disagree with Dr. Dall’s assertions regarding the ASPN Guideline and his commentary on the referenced Calodney et al paper.1,2 The reasons for study withdrawal were clearly detailed in the paper (Table 2, page 1213). It is recognized that the “lost-to-follow-up” rate was relatively elevated; however, this was explained in the manuscript. The study was conducted amid the COVID pandemic, with limitations on patient retention due to mandatory lockdown across all the study sites. Published data illustrate a decrease in non-COVID related study enrollment as high as 59% during the peak of the covid pandemic.3 This was a likely large contributor to the subjects lost to follow up. The COVID pandemic should have impacted all subjects equally, therefore would not be biased unilaterally toward subjects with positive vs negative outcomes. It would also be expected that if any subject had severe AEs requiring revision, or very negative outcomes, that they would have been more likely to follow up, as the study PIs were each subject’s treating physician. The statistical analysis is accurate based on the data available for subjects who continued in the study.

Regarding Dr. Dall’s comments on the methodology for developing the ASPN Guideline, we vehemently oppose the suggestion to remove the section on minimally invasive posterior SI fusion with allograft based on the singular loss of follow-up % of one study on an entire category of sacroiliac treatment. Posterior allograft sacroiliac joint treatment has emerged as a common treatment modality for those suffering from sacroiliac dysfunction and appropriate educational resources like the ASPN SI joint guideline were developed to ensure the safe and effective utilization of this treatment category.

On a more global level, the American Society of Pain and Neuroscience has a transparent methodology on guideline development utilizing well validated and published criteria.1,4,5 The current guideline in question included 20 international content experts from multiple disciplines including surgical, interventional, and radiological specialties. All conflicts of interest are disclosed, and conflicted authors must abstain from clinical grading on any clinical recommendation if a conflict exists, which minimizes any bias in the development of ASPN guidelines.

Finally, our own literature search has discovered that Dr. Dall does have texts for purchase online for sacroiliac joint surgery and believes that this should have been disclosed as a conflict of interest in his letter to the editor, as this may influence his opinions on the ASPN SI joint guideline given a potential financial incentive to promote his opinions and texts for purchase.

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 PainTEQ, CornerLoc, and Spinal Simplicity. VTF receives research funding from Nevro Corporation part of an investigator-initiated study grant that is not related to this manuscript. TEW is a consultant for Medtronic and has received research funding from Medtronic, SPR Therapeutics, Nevro, and Boston Scientific. JSW is a consultant for Abbott, SI Bone, Vertos Medical, Biotronik, Saluda, and AbbVie, receives research funding from Abbott, SI Bone, Saluda, and Medtronic, serves on an advisory board for Abbott, SI Bone, Vertos Medical, and Biotronik, and serves on a speaker board for Abbott, SI Bone, & AbbVie. RSD receives investigator- initiated research grant funding from Nevro Corp and Saol Therapeutics that is paid to his institution. KA is a consultant for Nevro, Saluda, Biotronik, Boston Scientific, and Presidio, reports minor options from PainTEQ. MJD is a consultant for Globus, Camber, LifeSpine, Vyrsa, PainTEQ, Nevro, Abbott, and Biotronik. DTDN is a consultant for SI Bone, Stratus Medical, and Neurovassis. CB is a consultant for Nevro, Abbott, Vertos, Spinal Simplicity, and PainTEQ; reports personal fees from Nevro, Spinal Simplicity, PainTEQ, and Boston Scientific, outside the submitted work. AA is a consultant for Curonix, Medtronic and Avanos. The authors report no other conflicts of interest in this communication.

1. Sayed D, Deer TR, Tieppo Francio V, et al. American Society of Pain and Neuroscience Best Practice (ASPN) Guideline for the treatment of sacroiliac disorders. J Pain Res. 2024;17:1601–1638. PMID: 38716038; PMCID: PMC11075694. doi:10.2147/JPR.S464393

2. Calodney A, Azeem N, Buchanan P, et al. Safety, efficacy, and durability of outcomes: results from SECURE: a single arm, multicenter, prospective, clinical study on a minimally invasive posterior sacroiliac fusion allograft implant. J Pain Res. 2024;17:1209–1222. doi:10.2147/JPR.S458334

3. Hawila N, Berg A. Assessing the impact of COVID-19 on registered interventional clinical trials. Clin Transl Sci. 2021;14(3):1147–1154. PMID: 33769709; PMCID: PMC8212742. doi:10.1111/cts.13034

4. Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of interventional treatments for low back pain. J Pain Res. 2022;15:3729–3832. Erratum in: J Pain Res. 2022 Dec 24;15:4075–4076. doi: 10.2147/JPR.S402370. PMID: 36510616; PMCID: PMC9739111. doi:10.2147/JPR.S386879

5. Deer TR, Grider JS, Pope JE, et al. Best practices for minimally invasive lumbar spinal stenosis treatment 2.0 (MIST): consensus Guidance from the American Society of Pain and Neuroscience (ASPN). J Pain Res. 2022;15:1325–1354. PMID: 35546905; PMCID: PMC9084394. doi:10.2147/JPR.S355285

© 2024 The Author(s). This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.