Predictors of Decompressive Laminectomy Outcomes
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 50 - 90 |
| Updated: | 2/1/2019 |
| Start Date: | October 1, 2014 |
| End Date: | December 31, 2019 |
Toward Optimizing Decompressive Laminectomy Outcomes: Looking Outside the Spine
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.
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.
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.
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.
Inclusion Criteria:
- Younger than 90 years old.
- no communication barriers (e.g., English speaking, household telephone)
- Affirmative response to each of the three following questions:
- a) Do patients have pain, weakness, numbness, or tingling in their legs when
walking standing?
- b) Does this pain, weakness, numbness or tingling in their legs interfere with
their daily activities?
- c) Have patients tried at least one non-surgical treatment for their leg symptoms
(e.g., physical therapy, pain medications, spinal injection)?
- Have been scheduled for surgery on lower back for a condition called lumbar spinal
stenosis.
Exclusion Criteria:
- non degenerative causes of LSS such as
- tumor,
- infection,
- trauma,
- hemorrhage,
- or epidural lipomatosis
- Prior lumbar spinal surgery
- spondylolisthesis with spinal instability
- significant cognitive impairment
We found this trial at
7
sites
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Pittsburgh, Pennsylvania 15240
Principal Investigator: Debra K. Weiner, MD
Phone: 202-443-5766
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