Predictors of Decompressive Laminectomy Outcomes
Condition: Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis
Study type: Observational

Summary: 
      Decompressive laminectomy (DL) is the most common type of back surgery performed in older
      adults; DL treats lumbar spinal stenosis (LSS), a degenerative narrowing of the spinal canal
      causes pain and trouble walking. An estimated one in three people who undergo DL do not get
      well and often undergo repeated surgery.1,3-6 Some studies indicate that conditions outside
      of the spine (e.g., depression, hip arthritis) cause people who undergo DL to do
      poorly,27,30-36 but no one has comprehensively examined these conditions or the impact of
      treating them on DL outcomes. Thus LSS treatment continues to focus on the spine alone.61 The
      aim of this study is to identify conditions other than LSS that place Veterans at risk of
      poor DL outcomes so that future comparative effectiveness studies can be designed that
      examine the impact of a more comprehensive approach to treatment. Investigators believe that
      a patient-centered rather than a disease-centered approach will lead to superior outcomes,
      less suffering, and more appropriate use of health care resources.
    

Detailed description: 
      The primary aim of this 6-site prospective cohort study is to develop algorithms usable in
      the clinical setting that predict decompressive laminectomy (DL) outcomes (i.e., success vs.
      failure) in older adults with lumbar spinal stenosis (LSS), the most common indication for
      spine surgery in older patients. The clinical algorithms developed will be based primarily on
      factors outside of LSS that are important aging-related predictors of pain and disability
      (e.g., hip osteoarthritis (OA), fibromyalgia syndrome, depression, anxiety, fear-avoidance
      beliefs, dysfunctional coping). Preliminary data support the impact of some of these factors
      on DL outcomes, but no study has included comprehensive assessment of rigorously collected
      data in the context of a prospective cohort. Thus LSS treatment remains focused exclusively
      on the lumbar spine and treatment outcomes suboptimal with, on average, < 20% reduction in
      pain. An estimated one in three DL patients does not improve at all. Further, anatomical
      evidence of LSS (i.e., based on advanced imaging) exists in many older patients without pain
      or functional compromise. Two hundred fifty patients with symptomatic LSS scheduled to
      undergo DL without fusion and who have no dementia, spinal instability, or prior lumbar
      surgery will be recruited from spine surgery practices at each of the 6 participating sites
      (VA Pittsburgh Healthcare System, Durham VA Medical Center [MC], Richmond VAMC, Ann Arbor
      VAMC, Denver VAMC, San Antonio VAMC). Within 30 days prior to DL (i.e., at baseline),
      participants will undergo comprehensive and rigorous assessment of pain and
      disability-generating factors including: 1) SS symptoms with the Brigham Spinal Stenosis
      questionnaire (BSS, the most specific available LSS measurement tool); 2) musculoskeletal
      comorbidities (scoliosis, kyphosis, hip osteoarthritis, fibromyalgia symptoms, severity of
      spinal stenosis, degenerative disc and facet disease); 3) mood (depression [with the Centre
      for Epidemiology Studies Depression Scale (CES-D)], anxiety [with the GAD-7]); 4) cognitive
      function (normal vs. mild cognitive impairment with the computer-based assessment of mild
      cognitive impairment); 5) psychological function (fear-avoidance beliefs [with the Fear
      Avoidance Beliefs Questionnaire], chronic pain self-efficacy [with the Chronic Pain
      Self-Efficacy Scales], dysfunctional pain coping skills [with the Cognitive Strategies
      Questionnaire], treatment expectancy, illicit substance use, alcohol use, smoking status,
      PTSD symptoms); 6) medical comorbidity (including BMI); 7) demographic factors (age, gender,
      race, educational/marital status). The BSS will be collected at baseline, at the first
      postoperative visit, and every 3 months for one year. Prediction rules, based on the
      comprehensive set of factors measured and DL success/failure determined by the BSS, will be
      created using multiple methods to maximize predictive accuracy and validated subsequently in
      a separate cohort of 100 individuals. Investigators will apply these rules to future
      comparative effectiveness trials that test personalized LSS treatment approaches (i.e., that
      involve targeting extra-LSS factors as part of the total treatment package) as compared with
      DL alone. An exploratory aim of the proposed study is to evaluate the use of Goal Attainment
      Scaling (GAS) as a DL outcome. This patient-centered outcomes measurement approach is used
      commonly in the rehabilitation setting, but never before in DL patients. To prepare for
      future comparative effectiveness trials, investigators want to develop GAS as an outcome
      measure because it can be used to track outcomes in SS patients across surgical and
      non-surgical interventions, and investigators anticipate that both will be employed as part
      of personalized treatment. Investigators will explore (through 10-12 patient interviews) and
      refine (with a modified Delphi panel of experts) GAS goals in patients with SS, and measure
      goal achievement in a subset of 20 participants. What might happen if older adults with LSS
      were treated in the context of a comprehensive pre-operative program before undergoing DL?
      Might long-term outcomes associated with DL improve? Might patient satisfaction improve?
      Might some patients avoid DL? These are questions that ultimately investigators hope to
      answer.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        350 Veterans with degenerative lumbar spinal stenosis (LSS) who are scheduled to undergo
        decompressive laminectomy (DL) will be recruited. No one will be excluded on the basis of
        age, race, gender or ethnicity. There is no age restriction as investigators are targeting
        patients with degenerative lumbar spinal stenosis, most of who are in their 50's and 60's.
        Investigators exclude participants with non-degenerative causes of LSS, as noted below.
        Investigators anticipate that the demographics of the participants will reflect that of the
        three participating VA sites and their affiliated University spine surgery practices. Our
        goal is to recruit at least 70% Veteran participants and Investigators have added three
        additional VA sites that will help to ensure this.
      
Keywords: laminectomy