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Long-term outcomes of lumbar epidural steroid injections for spinal stenosis
Investigator (PI): Friedly, Janna
Performing Organization (PO): (Current): University of Washington, Comparative Effectiveness, Cost and Outcomes Research Center / (206) 744-1800
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2013
Final Year: 2018
Record Source/Award ID: PCORI/CE-12-11-4469
Funding: Total Award Amount: $2,143,538
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Spinal stenosis is one of the most common causes of low back pain among older adults and can result in significant disability. Despite this, we still do not know which treatments for spinal stenosis are most effective, nor do we know what outcomes are most important to these older adults. We propose to answer a number of questions about spinal stenosis by interviewing a diverse group of older adults with spinal stenosis. We are currently conducting a clinical trial of epidural steroid injections (ESI) for spinal stenosis (LESS trial), and we propose to interview the patients who have completed the trial, as well as other older adults with spinal stenosis, to help us understand what is important to them in terms of outcomes. We have successfully recruited more than 300 subjects in 16 US sites (we expect to reach our goal of 400 by 5/13). We seek to answer the following key questions. Aim 1: Outcomes of importance to patients: (1a) What are the most important treatment outcomes to older adults with spinal stenosis? (1b) Do outcome measures for pain and function commonly used in back pain trials adequately reflect what is most important to older adult patients with spinal stenosis? (1c) What is the minimum improvement from ESI that older adults with spinal stenosis consider worthwhile? Aim 2: Individualized decision aids: (2a) Do decision aids tailored to older adults with spinal stenosis change patient decision making regarding subsequent treatments? (2b) Do patients respond differently at subsequent outcome assessment time points after receiving tailored decision aids that contain their own individual outcome data from prior treatments? Aim 3: Long-term outcomes: (3a) What are the long-term risks and benefits of ESI for spinal stenosis? (3b) Which subgroups of patients are most likely to benefit long-term from ESI for spinal stenosis? We propose to answer these important questions using several strategies. To identify and prioritize outcomes important to patients, we will conduct focus groups with a diverse group of older adults with spinal stenosis. We will provide LESS patients with an individualized report of their outcomes and treatment(s) they received. We will randomly give half of the patients these reports before the interview and half after the study ends. We will interview participants to see how decision aids influence decision making about future treatments and change outcomes. In aim 3, we will determine what patient and disease characteristics predict long-term outcomes identified and confirmed in aims 1 and 2 to be most important to patients. Given the diverse patient population in LESS and the extensive data that we will have on baseline characteristics, as well as long-term outcomes of importance to patients, we will be able to provide concrete information back to patients and providers to help them make decisions based on a patients' unique combination of disease and patient characteristics, as well as their desired outcome and values. More on this project: (1) Suri P, Pashova H, Heagerty PJ, Jarvik JG, Turner JA, Comstock BA, Bauer Z, Annaswamy TM, Nedeljkovic SS, Wasan AD, Friedly JL. Short-term improvements in disability mediate patient satisfaction after epidural corticosteroid injections for symptomatic lumbar spinal stenosis. Spine (Phila Pa 1976). 2015 Sep 1;40(17):1363-70. doi: 10.1097/BRS.0000000000001000. PubMed PMID: 26010037. (2) Edwards TC, Lavallee DC, Bauer Z, Comstock BA, Jarvik JG, Patrick DL, Makris UE, Friedly JL. Problem areas identified as important to older adults with lumbar spinal stenosis. Spine J. 2015 Jul 1;15(7):1636-44. doi: 10.1016/j.spinee.2015.03.008. PubMed PMID: 25791366. (3) J.A. Turner, B.A. Comstock, C. Standaert, P.J. Heagerty, J.G. Jarvik, R.A. Deyo, A.D. Wasan, S.S. Nedeljkovic, J.L. Friedly, Can Patient Characteristics Predict Benefit from Epidural Corticosteroid Injections for Lumbar Spinal Stenosis Symptoms? The Spine Journal. 2015 Nov 1;15(11):2319-31. doi: 10.1016/j.spinee.2015.06.050. doi: .1016/j.spinee.2015.06.050.
MeSH Terms:
  • Aged
  • Decision Making
  • Decision Support Techniques
  • Humans
  • Injections, Epidural /*methods
  • Multicenter Studies as Topic
  • Outcome Assessment (Health Care)
  • Patient Participation
  • Patient Preference
  • Randomized Controlled Trials as Topic
  • Spinal Stenosis /*drug therapy
  • Steroids /*administration & dosage
  • Time Factors
  • United States
Country: United States
State: Washington
Zip Code: 98104
UI: 20143306
CTgovId: NCT02260401
Project Status: Completed
Record History: ('2017: Project extended to 2018.',)