Lumbar Spinal StenosisNCT02215551
Predictors of Decompressive Laminectomy Outcomes
An observational study of Lumbar Spinal Stenosis, run by VA Office of Research and Development at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spinal Stenosis
- Type of treatment
- Injection or infusion
- How many people
- 239 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Oct 2014to 10 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- non degenerative causes of LSS such as
- tumor,
- infection,
- trauma,
- hemorrhage,
- or epidural lipomatosis
Show all 9Show fewer
- Prior lumbar spinal surgery
- spondylolisthesis with spinal instability
- significant cognitive impairment
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, 80220
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229
About this study
Official title: 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.
Read the 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.
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- laminectomy
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brigham Spinal Stenosis Questionnaire
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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study start1 Oct 2014
- Primary completion1 Jul 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Debra K. Weiner, MD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215551
- Sponsor's protocol ID
- O0798-R
- Status last verified
- Jan 2023
- First submitted
- 22 Jul 2014
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward Optimizing Decompressive Laminectomy Outcomes: Looking Outside the Spine
- ClinicalTrials.gov ID
- NCT02215551
- Acronym / sponsor ID
- O0798-R
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- laminectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Younger than 90 years old.
- no communication barriers (e.g., English speaking, household telephone)
- Affirmative response to each of the three following questions:
- Have been scheduled for surgery on lower back for a condition called lumbar spinal stenosis.
Key exclusion criteria (9 listed)
- non degenerative causes of LSS such as
- Prior lumbar spinal surgery
- spondylolisthesis with spinal instability
- significant cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra K. Weiner, MD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by VA Office of Research and Development at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brigham Spinal Stenosis Questionnaire (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.