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Predictors of Decompressive Laminectomy Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215551
Recruitment Status : Active, not recruiting
First Posted : August 13, 2014
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease
Lumbar Spinal Stenosis

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.

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Toward Optimizing Decompressive Laminectomy Outcomes: Looking Outside the Spine
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Group/Cohort
Study Group

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.

Whom have 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.




Primary Outcome Measures :
  1. Brigham Spinal Stenosis Questionnaire [ Time Frame: 1 Year ]
    The BSS has three scales that measure pain, function, and satisfaction. The pain and satisfaction scales can be administered before and after DL; the satisfaction scale measures satisfaction with surgery and is only administered following DL. Threshold values have been defined for success versus failure on each of the three subscales based on receiver operating characteristic (ROC) analyses - 0.46 for the Symptom Severity Scale, 0.42 for the Physical Function Scale, and 2.42 for the Patient Satisfaction Scale. The most balanced definition of overall success requires that the patient achieve success in at least two of the three scales. Investigators use this definition, which has the greatest sensitivity and specificity, as the primary outcome in our statistical analyses.


Other Outcome Measures:
  1. Goal Attainment Scaling (GAS) [ Time Frame: 1 Year ]
    Goal Attainment Scaling is a structured interview that allows for standardized measurement of physical function goals in terms of the degree to which they have been attained for each individual person.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215551


Locations
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United States, Colorado
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, United States, 80220
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
United States, Texas
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, United States, 78229
United States, Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Debra K. Weiner, MD VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02215551    
Other Study ID Numbers: O0798-R
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
laminectomy
Additional relevant MeSH terms:
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Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases