187. Injection Treatment Effectively Reduces Lower Back Pain Associated with Lumbar Spinal Stenosis...

1
John Hurlburt, MD, PhD 3 , Richard Fox, FRCSC, MD 4 , Stephen Lewis, MD 2 , Marcel Dvorak, MD, FRCSC 1 ; 1 University of British Columbia, Vancouver, British Columbia, Canada; 2 University of Toronto, Toronto, Ontario, Canada; 3 Calgary, Alberta, Canada; 4 University of Alberta, Edmonton, Alberta, Canada BACKGROUND CONTEXT: Controversy and inconsistency surround the oncologic management of primary bone tumors of the spine (PBTS). Previous case series suggest the Enneking Classification and its emphasis on resection margin can be applied safely and effectively, appearing to de- crease local recurrence and mortality. Stronger levels of evidence support- ing its effectiveness should facilatate standardization of care. PURPOSE: The purpose of this study is to determine whether applying the Enneking Classification, and its principles of surgical margin, to the management of PBTS significantly decreases: 1. local recurrence and 2.mortality. STUDY DESIGN/SETTING: An ambispective multi-center Cohort Study. PATIENT SAMPLE: Inclusion criteria were PBTS treated with surgi- cal resection between Jan 1982 and Jan 2008 at one of four tertiary spine oncology centers. Patients with known metastatic disease and re- vision surgery were excluded. Baseline demographic and surgical vari- ables were recorded. Patients were staged using the Enneking system. Based on the final pathology report of an experienced MSK Tumor Pa- thologist patients were divided into 2 cohorts: those resected with intra- lesional margins(control) and those with marginal or wide margins(en bloc). OUTCOME MEASURES: Survivor analysis with the endpoints of local recurrence and mortality. Perioperative and postoperative complications. METHODS: The 2 cohorts were compared for local recurrence and sur- vival using Kaplan-Meier survival curves and log-rank test. To further re- fine results, covariate analysis was conducted using Cox proportional hazard model. Age, gender, tumor grade (low and high), adjuvant therapy and spine level were evaluated together with treating center variable for their impact on the relationship between the study group and outcomes. Significance was decided by p-value less than 0.05. RESULTS: A statistically significant decrease in local recurrence (p50.0001) was observed in favor of wide or marginal (en bloc) resection. In patients with local recurrence there was a significant increased risk of mortality, (p !0.0001). There was a trend to decreased mortality in the en bloc resection group, not statistically significant (p50.3). Complica- tions were higher in the en bloc group but these did not have an adverse effect on early or late mortality. CONCLUSIONS: In spine oncology centers, the application of the En- neking classification when managing PBTS significantly reduces local re- currence. Optimal management for PBTS should utilize the Enneking Classification to minimize local recurrence and probably increase survival. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2009.08.226 Friday, November 13, 2009 4:10–5:10 PM Focused Paper Presentations 4: Injections 187. Injection Treatment Effectively Reduces Lower Back Pain Associated with Lumbar Spinal Stenosis in Older Adults Virginia Briggs 1 , Patricia Franklin, MD, MPH, MBA 2 , Thomas McLaughlin 1 , Wenjun Li, PhD 1 , David Lombardi 3 , Mark Kaplan, MD 1 , Mark Eskander, MD 1 ; 1 University of Massachusetts Medical School (Worcester), Worcester, MA, USA; 2 Worcester, MA, USA; 3 Liberty Mutual Research Institute, Hopkinton, MA, USA BACKGROUND CONTEXT: Lumbar spinal stenosis (LSS) is a common condition that causes pressure on the spinal cord and nerve roots, resulting in lower back and leg pain. LSS is commonly caused by degenerative changes in older adults. Treatments to reduce pain include both surgical and non-surgical interventions. Many physicians and patients choose non-surgical methods for treatment such as injections. As the proportion of older adults in the general population grows each year, it is expected that degenerative changes associated with LSS will increase. Older patients may likely continue to seek alternative, less invasive treatments for their lower back pain. However, much of the research to date has been con- ducted among younger patients with LSS. PURPOSE: Injection treatment is a commonly used non-surgical proce- dure to alleviate lower back pain. Information is lacking about the effec- tiveness of injection treatment, particularly in older adults. This study quantified the amount of pain relief reported by adults 60 years and over who were diagnosed with degenerative lumbar spinal stenosis, a common cause of lower back pain in older adults. STUDY DESIGN/SETTING: Patients scheduled for injection treatment were prospectively selected from a high volume spine center. PATIENT SAMPLE: All patients; 60 years old, who had been diagnosed with lumbar spinal stenosis and were scheduled to receive an injection for lower back pain at the Spine Center were eligible. Diagnosis of LSS was confirmed using Magnetic Resonance Imaging reports and clinical notes. Exclusion criteria included previous lumbar injection in the past 6 months, lumbar surgery within the past 2 years and history of lumbar fracture. OUTCOME MEASURES: The SF-36 Questionnaire is one of the most frequently used questionnaires to assess health related quality of life in patients with back pain. In this study, two components were used; the Pain sub-score of the PCS (primary outcome) and the MCS (covariate). METHODS: Patients were enrolled between January 1 and July 1, 2008 and followed for 3 months. Post-injection Pain scores were compared to baseline using T-tests and univariate and multivariate regressions. RESULTS: Of 78 patients meeting study inclusion criteria, the mean Pain score at baseline was 28.6, 43.2 at 1 month and 38.0 at 3 months. Using t- tests between baseline and 1 month and between baseline and 3 months, mean Pain scores were significantly improved in all patient characteristic categories at both timepoints. Change in Pain score was examined using univariate and multivariate mixed models for all patient characteristics. Higher emotional status (SF-36 MCS) was associated with improvement in pain at one month in both univariate (p50.09) and multivariate (p50.02) models. It was found that for every 10 points a patient’s MCS increased, there was an increase of almost 4 points of their Pain score. Change in Pain score was not significant at 3 months. CONCLUSIONS: Injection treatment effectively decreases lower back pain in older adults with lumbar spinal stenosis. Clinicians will have more information available about pain relief when discussing treatment options with their older patients. In addition, higher emotional status increases the amount of pain relief experienced at 1 month following injection. Clini- cians may choose to recommend mental health treatment for patients with low emotional status prior to beginning injections. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2009.08.228 188. Gastrointestinal Tolerability of Tapentadol Extended Release Treatment for Chronic Low Back Pain Harvey Leslie, MD 1 , Douglas Shapiro, MD, PhD 2 , Akiko Okamoto 2 , Ilse Van Hove 3 , Thomas Haeufel 4 , Mila Etropolski 2 ; 1 Best Clinical 98S Proceedings of the NASS 24th Annual Meeting / The Spine Journal 9 (2009) 1S–205S

Transcript of 187. Injection Treatment Effectively Reduces Lower Back Pain Associated with Lumbar Spinal Stenosis...

Page 1: 187. Injection Treatment Effectively Reduces Lower Back Pain Associated with Lumbar Spinal Stenosis in Older Adults

98S Proceedings of the NASS 24th Annual Meeting / The Spine Journal 9 (2009) 1S–205S

John Hurlburt, MD, PhD3, Richard Fox, FRCSC, MD4, Stephen Lewis,

MD2, Marcel Dvorak, MD, FRCSC1; 1University of British Columbia,

Vancouver, British Columbia, Canada; 2University of Toronto, Toronto,

Ontario, Canada; 3Calgary, Alberta, Canada; 4University of Alberta,

Edmonton, Alberta, Canada

BACKGROUND CONTEXT: Controversy and inconsistency surround

the oncologic management of primary bone tumors of the spine (PBTS).

Previous case series suggest the Enneking Classification and its emphasis

on resection margin can be applied safely and effectively, appearing to de-

crease local recurrence and mortality. Stronger levels of evidence support-

ing its effectiveness should facilatate standardization of care.

PURPOSE: The purpose of this study is to determine whether applying

the Enneking Classification, and its principles of surgical margin, to the

management of PBTS significantly decreases: 1. local recurrence and

2.mortality.

STUDY DESIGN/SETTING: An ambispective multi-center Cohort

Study.

PATIENT SAMPLE: Inclusion criteria were PBTS treated with surgi-

cal resection between Jan 1982 and Jan 2008 at one of four tertiary

spine oncology centers. Patients with known metastatic disease and re-

vision surgery were excluded. Baseline demographic and surgical vari-

ables were recorded. Patients were staged using the Enneking system.

Based on the final pathology report of an experienced MSK Tumor Pa-

thologist patients were divided into 2 cohorts: those resected with intra-

lesional margins(control) and those with marginal or wide margins(en

bloc).

OUTCOME MEASURES: Survivor analysis with the endpoints of

local recurrence and mortality. Perioperative and postoperative

complications.

METHODS: The 2 cohorts were compared for local recurrence and sur-

vival using Kaplan-Meier survival curves and log-rank test. To further re-

fine results, covariate analysis was conducted using Cox proportional

hazard model. Age, gender, tumor grade (low and high), adjuvant therapy

and spine level were evaluated together with treating center variable for

their impact on the relationship between the study group and outcomes.

Significance was decided by p-value less than 0.05.

RESULTS: A statistically significant decrease in local recurrence

(p50.0001) was observed in favor of wide or marginal (en bloc) resection.

In patients with local recurrence there was a significant increased risk of

mortality, (p!0.0001). There was a trend to decreased mortality in the

en bloc resection group, not statistically significant (p50.3). Complica-

tions were higher in the en bloc group but these did not have an adverse

effect on early or late mortality.

CONCLUSIONS: In spine oncology centers, the application of the En-

neking classification when managing PBTS significantly reduces local re-

currence. Optimal management for PBTS should utilize the Enneking

Classification to minimize local recurrence and probably increase survival.

FDA DEVICE/DRUG STATUS: This abstract does not discuss or include

any applicable devices or drugs.

doi: 10.1016/j.spinee.2009.08.226

Friday, November 13, 20094:10–5:10 PM

Focused Paper Presentations 4: Injections

187. Injection Treatment Effectively Reduces Lower Back Pain

Associated with Lumbar Spinal Stenosis in Older Adults

Virginia Briggs1, Patricia Franklin, MD, MPH, MBA2,

Thomas McLaughlin1, Wenjun Li, PhD1, David Lombardi3, Mark Kaplan,

MD1, Mark Eskander, MD1; 1University of Massachusetts Medical School

(Worcester), Worcester, MA, USA; 2Worcester, MA, USA; 3Liberty Mutual

Research Institute, Hopkinton, MA, USA

BACKGROUND CONTEXT: Lumbar spinal stenosis (LSS) is a common

condition that causes pressure on the spinal cord and nerve roots, resulting

in lower back and leg pain. LSS is commonly caused by degenerative

changes in older adults. Treatments to reduce pain include both surgical

and non-surgical interventions. Many physicians and patients choose

non-surgical methods for treatment such as injections. As the proportion

of older adults in the general population grows each year, it is expected

that degenerative changes associated with LSS will increase. Older patients

may likely continue to seek alternative, less invasive treatments for their

lower back pain. However, much of the research to date has been con-

ducted among younger patients with LSS.

PURPOSE: Injection treatment is a commonly used non-surgical proce-

dure to alleviate lower back pain. Information is lacking about the effec-

tiveness of injection treatment, particularly in older adults. This study

quantified the amount of pain relief reported by adults 60 years and over

who were diagnosed with degenerative lumbar spinal stenosis, a common

cause of lower back pain in older adults.

STUDY DESIGN/SETTING: Patients scheduled for injection treatment

were prospectively selected from a high volume spine center.

PATIENT SAMPLE: All patients; 60 years old, who had been diagnosed

with lumbar spinal stenosis and were scheduled to receive an injection for

lower back pain at the Spine Center were eligible. Diagnosis of LSS was

confirmed using Magnetic Resonance Imaging reports and clinical notes.

Exclusion criteria included previous lumbar injection in the past 6

months, lumbar surgery within the past 2 years and history of lumbar

fracture.

OUTCOME MEASURES: The SF-36 Questionnaire is one of the most

frequently used questionnaires to assess health related quality of life in

patients with back pain. In this study, two components were used; the Pain

sub-score of the PCS (primary outcome) and the MCS (covariate).

METHODS: Patients were enrolled between January 1 and July 1, 2008

and followed for 3 months. Post-injection Pain scores were compared to

baseline using T-tests and univariate and multivariate regressions.

RESULTS: Of 78 patients meeting study inclusion criteria, the mean Pain

score at baseline was 28.6, 43.2 at 1 month and 38.0 at 3 months. Using t-

tests between baseline and 1 month and between baseline and 3 months,

mean Pain scores were significantly improved in all patient characteristic

categories at both timepoints. Change in Pain score was examined using

univariate and multivariate mixed models for all patient characteristics.

Higher emotional status (SF-36 MCS) was associated with improvement

in pain at one month in both univariate (p50.09) and multivariate

(p50.02) models. It was found that for every 10 points a patient’s MCS

increased, there was an increase of almost 4 points of their Pain score.

Change in Pain score was not significant at 3 months.

CONCLUSIONS: Injection treatment effectively decreases lower back

pain in older adults with lumbar spinal stenosis. Clinicians will have more

information available about pain relief when discussing treatment options

with their older patients. In addition, higher emotional status increases the

amount of pain relief experienced at 1 month following injection. Clini-

cians may choose to recommend mental health treatment for patients with

low emotional status prior to beginning injections.

FDA DEVICE/DRUG STATUS: This abstract does not discuss or include

any applicable devices or drugs.

doi: 10.1016/j.spinee.2009.08.228

188. Gastrointestinal Tolerability of Tapentadol Extended Release

Treatment for Chronic Low Back Pain

Harvey Leslie, MD1, Douglas Shapiro, MD, PhD2, Akiko Okamoto2,

Ilse Van Hove3, Thomas Haeufel4, Mila Etropolski2; 1Best Clinical