Placebo Effect of Sham Spine Procedures in Chronic Low Back Pain: A Systematic Review

References

• Gu AP, Gu CN, Ahmed AT, et al. Sham surgical procedures for pain intervention result in significant improvements in pain: systematic review and meta-analysis. J Clin Epidemiol. 2017;83:18–23. doi:10.1016/j.jclinepi.2016.12.010
   PubMed Web of Science ®Google Scholar
• Beard DJ, Campbell MK, Blazeby JM, et al. Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines). Lancet. 2020;395(10226):828–838. doi:10.1016/S0140-6736(19)33137-X
   PubMed Web of Science ®Google Scholar
• Cousins S, Blencowe NS, Blazeby JM. What is an invasive procedure? A definition to inform study design, evidence synthesis and research tracking. BMJ Open. 2019;9(7):e028576. doi:10.1136/bmjopen-2018-028576
   Web of Science ®Google Scholar
• Wartolowska KA, Feakins BG, Collins GS, et al. The magnitude and temporal changes of response in the placebo arm of surgical randomized controlled trials: a systematic review and meta-analysis. Trials. 2016;17(1):589. doi:10.1186/s13063-016-1720-7
   Web of Science ®Google Scholar
• Louw A, Diener I, Fernandez-de-las-penas C, Puentedura EJ. Sham surgery in orthopaedics: a systematic review of the literature. Pain Med. 2017;18:736–750. doi:10.1093/pm/pnw164
   Web of Science ®Google Scholar
• Savulescu J, Wartolowska K, Carr A. Randomised placebo-controlled trials of surgery: ethical analysis and guidelines. J Med Ethics. 2016;42(12):776–783. doi:10.1136/medethics-2015-103333
   PubMed Web of Science ®Google Scholar
• MedCalc statistical software. Belgium: MedCalc Software Ltd. Available from: https://www.medcalc.org. Accessed January 15, 2021.
   Google Scholar
• Mathsisfun statistical software. Available from: https://www.mathsisfun.com. Accessed January 15, 2021.
   Google Scholar
• Leclaire R, Fortin L, Lambert R, Bergeron YM, Rossignol M. Radiofrequency facet joint denervation in the treatment of low back pain: a placebo-controlled clinical trial to assess efficacy. Spine. 2001;26(13):1411–1416. doi:10.1097/00007632-200107010-00003
   PubMed Web of Science ®Google Scholar
• Pauza KJ, Howell S, Dreyfuss P, Peloza JH, Dawson K, Bogduk N. A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain. Spine J. 2004;4(1):27–35. doi:10.1016/j.spinee.2003.07.001
   Google Scholar
• Oh WS, Shim JC. A randomized controlled trial of radiofrequency denervation of the ramus communicans nerve for chronic discogenic low back pain. Clin J Pain. 2004;20:55–60. doi:10.1097/00002508-200401000-00011
   PubMed Web of Science ®Google Scholar
• Freeman BJ, Fraser RD, Cain CM, Hall DJ, Chapple DC. A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain. Spine. 2005;30(21):2369–2377. doi:10.1097/01.brs.0000186587.43373.f2
   Web of Science ®Google Scholar
• van Wijk RM, Geurts JW, Wynne HJ, et al. Radiofrequency denervation of lumbar facet joints in the treatment of chronic low back pain: a randomized, double-blind, sham lesion-controlled trial. Clin J Pain. 2005;21(4):335–344. doi:10.1097/01.ajp.0000120792.69705.c9
   PubMed Web of Science ®Google Scholar
• Tekin I, Mirzai H, Ok G, et al. A comparison of conventional and pulsed radiofrequency in denervation in the treatment of chronic facet joint pain. Clin J Pain. 2007;23:524. doi:10.1097/AJP.0b013e318074c99c
   PubMed Web of Science ®Google Scholar
• Cohen SP, Hurley RW, Buckenmaier CC, et al. Randomized placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac pain. Anesthesiology. 2008;109:279–288. doi:10.1097/ALN.0b013e31817f4c7c
   PubMed Web of Science ®Google Scholar
• Kvarstein G, Måwe L, Indahl A, et al. A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy–a 12-month follow-up. Pain. 2009;145(3):279–286. doi:10.1016/j.pain.2009.05.001
   Web of Science ®Google Scholar
• Peng B, Pang X, Wu Y, Zhao C, Song A. A randomized placebo-controlled trial of intradiscal methylene blue injection for the treatment of chronic discogenic low back pain. Pain. 2010;149(1):124–129. doi:10.1016/j.pain.2010.01.021
   PubMed Web of Science ®Google Scholar
• Cao P, Jiang L, Zhuang C, et al. Intradiscal injection therapy for degenerative chronic discogenic low back pain with end plate Modic changes. Spine J. 2011;11(2):100–106. doi:10.1016/j.spinee.2010.07.001
   PubMed Web of Science ®Google Scholar
• Patel N, Gross A, Brown L, et al. A randomized placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. Pain Med. 2012;13:383–398. doi:10.1111/j.1526-4637.2012.01328.x
   PubMed Web of Science ®Google Scholar
• Manchikanti L, Cash KA, McManus CD, Pampati V. Fluoroscopic caudal epidural injections in managing chronic low back pain without disc herniation radiculitis or facet joint pain. J Pain Res. 2012;5:381–390. doi:10.2147/JPR.S35924
   Google Scholar
• Kapural L, Vrooman B, Sarwar S, et al. A randomized, placebo-controlled trial of transdiscal radiofrequency, biacuplasty for treatment of discogenic lower back pain. Pain Med. 2013;14(3):362–373. doi:10.1111/pme.12023
   Web of Science ®Google Scholar
• van Tilburg CW, Stronks DL, Groeneweg JG, Huygen FJ. Randomised sham-controlled double-blind multicentre clinical trial to ascertain the effect of percutaneous radiofrequency treatment for lumbar facet joint pain. Bone Joint J. 2016;98- B(11):1526–1533. doi:10.1302/0301-620X.98B11.BJJ-2016-0379.R2
   Google Scholar
• van Tilburg CW, Schuurmans FA, Stronks DL, Groeneweg JG, Huygen FJ. Randomized sham-controlled double-blind multicenter clinical trial to ascertain the effect of percutaneous radiofrequency treatment for sacroiliac joint pain: three-month results. Clin J Pain. 2016;32(11):921–926. doi:10.1097/AJP.0000000000000351
   PubMed Web of Science ®Google Scholar
• van Tilburg CW, Stronks DL, Groeneweg JG, Huygen FJ. Randomized sham-controlled, double-blind, multicenter clinical trial on the effect of percutaneous radiofrequency at the ramus communicans for lumbar disc pain. Eur J Pain. 2017;21(3):520–529. doi:10.1002/ejp.945
   Web of Science ®Google Scholar
• Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2018;27(5):1146–1156. doi:10.1007/s00586-018-5496-1
   PubMed Web of Science ®Google Scholar
• Hostiuc S, Rentea I, Drima E, Negoi I. Placebo in surgical research: a case-based ethical analysis and practical consequences. Biomed Res Int. 2016:2627181. doi:10.1155/2016/2627181
   Web of Science ®Google Scholar
• Jonas WB, Crawford C, Colloca L, et al. To what extent are surgery and invasive procedures effective beyond a placebo response? A systematic review with meta-analysis of randomized, sham controlled trials. BMJ Open. 2015;5(12):e009655. doi:10.1136/bmjopen-2015-009655
   Web of Science ®Google Scholar
• Lu Y, Guzman JZ, Purmessur D, et al. Nonoperative management of discogenic back pain: a systematic review. Spine. 2014;39(16):1314–1324. doi:10.1097/BRS.0000000000000401
   Web of Science ®Google Scholar
• Wartolowska KA, Gerry S, Feakins BG, et al. A meta-analysis of temporal changes of response in the placebo arm of surgical randomized controlled trials: an update. Trials. 2017;18(1):1–7. doi:10.1186/s13063-017-2070-9
   Web of Science ®Google Scholar
• Klinger R, Stuhlreyer J, Schwartz M, Schmitz J, Colloca L. Clinical use of placebo effects in patients with pain disorders. Int Rev Neurobiol. 2018;139:107–128. doi:10.1016/bs.irn.2018.07.015
   PubMed Web of Science ®Google Scholar
• Vase L, Wartolowska K. Pain, placebo, and test of treatment efficacy: a narrative review. Br J Anaesth. 2019;123(2):e254–e262. doi:10.1016/j.bja.2019.01.040
   PubMed Web of Science ®Google Scholar
• Chapman JR, Norvell DC, Hermsmeyer JT, et al. Evaluating common outcomes for measuring treatment success for chronic low back pain. Spine. 2011;36(21 Suppl):S54–S68. doi:10.1097/BRS.0b013e31822ef74d
   PubMed Web of Science ®Google Scholar
• Chiarotto A, Boers M, Deyo RA, et al. Core outcome measurement instruments for clinical trials in nonspecific low back pain. Pain. 2018;159(3):481–495. doi:10.1097/j.pain.0000000000001117
   PubMed Web of Science ®Google Scholar
• Karcioglu O, Topacoglu H, Dikme O, Dikme O. A systematic review of the pain scales in adults: which to use? Am J Emerg Med. 2018;36(4):707–714. doi:10.1016/j.ajem.2018.01.008
   PubMed Web of Science ®Google Scholar