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Lumbar Stenosis Outcomes Research II (LUSTORII)

Primary Purpose

Lumbar Spinal Stenosis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
opana then darvocet then placebo
opana then placebo then darvocet
placebo then opana then darvocet
Placebo then darvocet then opana
Darvocet then opana then placebo
Darvocet then placebo then opana
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must present with clinical symptoms of neurogenic claudication (exercise induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or both legs provoked with walking and standing and relieved by sitting, squatting, or forward flexion posturing) and endorse limitation of walking tolerance due to these symptoms
  • Numeric Rating Scale (NRS) for pain ≥ 6 in response to the following question: "Circle one number (from 0=no pain to 10=worst pain) - How would you rate the worst leg and lower back pain you experienced during walking last week?"
  • Patients must have confirmatory imaging by MRI or CT scan demonstrating at least one level of lumbar spinal stenosis within 1 year
  • Duration of symptoms > 3 months
  • Age > 50 years; male or female

Exclusion Criteria:

  • Past or present existence of a movement disorder, e.g., Parkinsonism, or an neurologic disease that might affect the ability to ambulate (e.g., signs/symptoms of cauda equina compression)
  • Cognitive impairment preventing full understanding or participation in the study
  • Peripheral vascular disease
  • Moderate to severe arthritis of the knee or hip that might severely compromise ambulation
  • Past or present lower extremity peripheral vascular disease
  • Serious concomitant medical illness (e.g., heart disease) that might impair ambulation assessment
  • Previous lumbar surgery for spinal stenosis (laminectomy with or without fusion) within the past 2 years or epidural steroid injection in the preceding 4 months.
  • Severe psychiatric disorder
  • Mean time to severe symptoms > 15 minutes.
  • Epidural steroid treatment within the last three months
  • History of drug or alcohol dependence
  • Serious intercurrent illness
  • Hypersensitivity to oxymorphone hydrochloride
  • Hypersensitivity to propoxyphene or acetaminophen
  • Severe bronchial asthma or hypercarbia, morphine analogs such as codeine, or any of the other ingredients of Opana
  • Suspicion of paralytic ileus
  • Moderate or severe hepatic impairment
  • Major conduction abnormality on ECG or cardiac (Bruce protocol) stress test within the past year.
  • Ongoing treatment with a long-acting opioid or regularly-scheduled use of a short acting opioid (>3 doses/day on four or more days/week).

Sites / Locations

  • 2180 S. Clinton Ave

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Opana then darvocet then placebo

Opana then placebo then darvocet

Placebo then opana then darvocet

Placebo then darvocet then opana

Darvocet then opana then placebo

Darvocet then placebo then opana

Arm Description

Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.

Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.

Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.

Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.

Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.

Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.

Outcomes

Primary Outcome Measures

Time to First Symptoms (Tfirst) of Moderate Pain
Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured. Patients were excluded from the trial if there pain at rest was greater than or equal to 4/10.

Secondary Outcome Measures

Area Under the Curve
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals (every 30 seconds) subjects were asked what their pain level was according to the NRS. The area under the curve of present pain intensity is the total area combined for the amount of time the subject walked.
Total Distance
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. When the subject reached their maximum distance, the treadmill testing was stopped. This was recorded as total distance based on number of minutes and seconds walked. Minutes was converted to meters based on calculation of defined speed of the treadmill.
Recovery Time
After the subject completed the treadmill test they were asked to immediately return to the seated position. At this point a timer was started. When the subjects pain level returned to baseline (level of pain subject felt in a seated position before walking) the time was stopped. This was recorded as recovery time. Maximum recovery time is 15 minutes.
Visual Analog Scale (VAS)
The VAS asked subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.
Patient Global Assessment (PGA)
Subjects were asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA was measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.
Roland Morris Disability Questionnaire (RMDQ)
The RMDQ consists of 24 yes/no statements about activity limitations due to back pain. These questions center on movement, ambulation, and self-care activities. Positive (yes) answers each contribute 1 point to cumulative score with total scores ranging from 0 (no disability) to 24 (severely disabled).
Modified Brief Pain Inventory (mBPI)- Interference Score
The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven 11-point pain interference scales (0 indicating no interference and 10 indicating complete interference). For the interference score, a total score of 10 indicates pain completely interferes with activities.
Oswestry Disability Index (ODI) Score
The ODI is a set of 10 questions each with five choices (maximum score of 5 points per question) designed to determine how back pain has affected the ability to manage everyday life (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change positions). A score of 0 indicates no disability and total score of 50 would indicate 100% disability.
Swiss Spinal Stenosis Score- Symptom Severity
The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The symptom severity section is a set of 7 questions (maximum score is 5 points per question) and asks to rate pain for each question based on no pain, mild, moderate, severe or very severe pain. The total score (maximum=35) is added up and divided by seven. The maximum score for the symptom severity section (score=5) indicates very severe symptom severity.
Swiss Spinal Stenosis Score- Physical Function
The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The physical function section is a series of 5 questions (maximum 4 points per question) and asks to rate function for each question based on comfortably, sometimes with pain, always with pain, no functional ability. The total score (max=20) is divided by five. The maximum score for the physical function section (max=4) indicates no ability to function.
Final Pain
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals subjects were asked what their pain level was according to the NRS. When the subject reached their maximum distance, they were asked their NRS score. This was recorded as final pain intensity.

Full Information

First Posted
March 11, 2008
Last Updated
February 24, 2016
Sponsor
University of Rochester
Collaborators
Endo Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00652093
Brief Title
Lumbar Stenosis Outcomes Research II
Acronym
LUSTORII
Official Title
Lumbar Stenosis Outcomes Research II: Opana IR Versus Placebo and Active Control (Darvocet) for the Treatment of Walking Impairment in Lumbar Spinal Stenosis: A Double-Blind Randomized, Cross-Over Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Removal of Darvocet from US market
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Endo Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the proposed pilot study is to determine the efficacy of oxymorphone hydrochloride and propoxyphene/acetaminophen combination in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients lumbar spinal stenosis that have clinical symptoms of neurogenic claudication. Neurogenic claudication is defined as movement induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or both legs provoked with walking and standing and relieved by sitting, squatting, or forward flexion posturing. The secondary objective is to examine the functional benefit of oxymorphone hydrochloride and propoxyphene/acetaminophen combination with respect to improvement in duration and distance of walking.
Detailed Description
A computer-generated randomization plan was used for assignment of subjects to one of six treatment sequences (4 subjects per sequence): oxymorphone/propoxyphene/placebo, oxymorphone/placebo/propoxyphene, placebo/oxymorphone/propoxyphene, placebo/propoxyphene/oxymorphone, propoxyphene/oxymorphone/placebo, or propoxyphene/placebo/oxymorphone. One dose of blinded study drug (opana, propoxypehen, or placebo) was given at study days 1, 5, and 9. The primary endpoint was time to first symptoms of moderate intensity (NRS ≥ 4/10) during treadmill ambulation. Ambulation assessment was performed during the screening visit. Ambulation assessment was also performed 90 minutes after administration of study drug on days 1, 5 and 9, to evaluate pain intensity associated with walking as well as distance covered by the patients. Quantitative assessment of ambulation was conducted on a treadmill at 0° ramp incline at 1.2 miles per hour (mph). Measurement of self-reported symptom severity using the NRS at baseline, and every 30 seconds for a maximum of 15 minutes was recorded. The following information was also recorded: time to first symptoms, total ambulation time. The examination was stopped after 15 minutes or at the onset of severe symptoms. Severe symptoms were defined as the level of discomfort that would make patients stop walking in usual life situations. No one was encouraged or prompted to continue walking beyond this point. Patients were instructed to walk with an upright posture. They were not permitted to lean forward or hold onto the handrails during the examination. Secondary outcome measures included area under the curve of present pain intensity with ambulation at each specified time point, final pain intensity with walking, walking tolerance, time to return to baseline pain level after ambulation, as well as the results of a series of pain related questionnaires including: Visual Analog Scale (VAS), Patient Global Assessment (PGA), NRS, Roland Morris Disability Questionnaire (RMDQ), modified Brief Pain Inventory short form (mBPI-sf), Oswestry Disability Index (ODI), and Swiss Spinal Stenosis (SSS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Opana then darvocet then placebo
Arm Type
Experimental
Arm Description
Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
Arm Title
Opana then placebo then darvocet
Arm Type
Experimental
Arm Description
Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
Arm Title
Placebo then opana then darvocet
Arm Type
Experimental
Arm Description
Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
Arm Title
Placebo then darvocet then opana
Arm Type
Experimental
Arm Description
Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
Arm Title
Darvocet then opana then placebo
Arm Type
Experimental
Arm Description
Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
Arm Title
Darvocet then placebo then opana
Arm Type
Experimental
Arm Description
Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
Intervention Type
Drug
Intervention Name(s)
opana then darvocet then placebo
Other Intervention Name(s)
opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug
Intervention Description
Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
Intervention Type
Drug
Intervention Name(s)
opana then placebo then darvocet
Other Intervention Name(s)
opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug
Intervention Description
Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
Intervention Type
Drug
Intervention Name(s)
placebo then opana then darvocet
Other Intervention Name(s)
opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug
Intervention Description
Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
Intervention Type
Drug
Intervention Name(s)
Placebo then darvocet then opana
Other Intervention Name(s)
opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug
Intervention Description
Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
Intervention Type
Drug
Intervention Name(s)
Darvocet then opana then placebo
Other Intervention Name(s)
opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug
Intervention Description
Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
Intervention Type
Drug
Intervention Name(s)
Darvocet then placebo then opana
Other Intervention Name(s)
opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug
Intervention Description
Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
Primary Outcome Measure Information:
Title
Time to First Symptoms (Tfirst) of Moderate Pain
Description
Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured. Patients were excluded from the trial if there pain at rest was greater than or equal to 4/10.
Time Frame
study visit
Secondary Outcome Measure Information:
Title
Area Under the Curve
Description
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals (every 30 seconds) subjects were asked what their pain level was according to the NRS. The area under the curve of present pain intensity is the total area combined for the amount of time the subject walked.
Time Frame
study visit
Title
Total Distance
Description
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. When the subject reached their maximum distance, the treadmill testing was stopped. This was recorded as total distance based on number of minutes and seconds walked. Minutes was converted to meters based on calculation of defined speed of the treadmill.
Time Frame
study visit
Title
Recovery Time
Description
After the subject completed the treadmill test they were asked to immediately return to the seated position. At this point a timer was started. When the subjects pain level returned to baseline (level of pain subject felt in a seated position before walking) the time was stopped. This was recorded as recovery time. Maximum recovery time is 15 minutes.
Time Frame
study visit
Title
Visual Analog Scale (VAS)
Description
The VAS asked subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.
Time Frame
study visit
Title
Patient Global Assessment (PGA)
Description
Subjects were asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA was measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.
Time Frame
study visit
Title
Roland Morris Disability Questionnaire (RMDQ)
Description
The RMDQ consists of 24 yes/no statements about activity limitations due to back pain. These questions center on movement, ambulation, and self-care activities. Positive (yes) answers each contribute 1 point to cumulative score with total scores ranging from 0 (no disability) to 24 (severely disabled).
Time Frame
study visit
Title
Modified Brief Pain Inventory (mBPI)- Interference Score
Description
The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven 11-point pain interference scales (0 indicating no interference and 10 indicating complete interference). For the interference score, a total score of 10 indicates pain completely interferes with activities.
Time Frame
study visit
Title
Oswestry Disability Index (ODI) Score
Description
The ODI is a set of 10 questions each with five choices (maximum score of 5 points per question) designed to determine how back pain has affected the ability to manage everyday life (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change positions). A score of 0 indicates no disability and total score of 50 would indicate 100% disability.
Time Frame
study visit
Title
Swiss Spinal Stenosis Score- Symptom Severity
Description
The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The symptom severity section is a set of 7 questions (maximum score is 5 points per question) and asks to rate pain for each question based on no pain, mild, moderate, severe or very severe pain. The total score (maximum=35) is added up and divided by seven. The maximum score for the symptom severity section (score=5) indicates very severe symptom severity.
Time Frame
study visit
Title
Swiss Spinal Stenosis Score- Physical Function
Description
The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The physical function section is a series of 5 questions (maximum 4 points per question) and asks to rate function for each question based on comfortably, sometimes with pain, always with pain, no functional ability. The total score (max=20) is divided by five. The maximum score for the physical function section (max=4) indicates no ability to function.
Time Frame
study visit
Title
Final Pain
Description
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals subjects were asked what their pain level was according to the NRS. When the subject reached their maximum distance, they were asked their NRS score. This was recorded as final pain intensity.
Time Frame
study visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must present with clinical symptoms of neurogenic claudication (exercise induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or both legs provoked with walking and standing and relieved by sitting, squatting, or forward flexion posturing) and endorse limitation of walking tolerance due to these symptoms Numeric Rating Scale (NRS) for pain ≥ 6 in response to the following question: "Circle one number (from 0=no pain to 10=worst pain) - How would you rate the worst leg and lower back pain you experienced during walking last week?" Patients must have confirmatory imaging by MRI or CT scan demonstrating at least one level of lumbar spinal stenosis within 1 year Duration of symptoms > 3 months Age > 50 years; male or female Exclusion Criteria: Past or present existence of a movement disorder, e.g., Parkinsonism, or an neurologic disease that might affect the ability to ambulate (e.g., signs/symptoms of cauda equina compression) Cognitive impairment preventing full understanding or participation in the study Peripheral vascular disease Moderate to severe arthritis of the knee or hip that might severely compromise ambulation Past or present lower extremity peripheral vascular disease Serious concomitant medical illness (e.g., heart disease) that might impair ambulation assessment Previous lumbar surgery for spinal stenosis (laminectomy with or without fusion) within the past 2 years or epidural steroid injection in the preceding 4 months. Severe psychiatric disorder Mean time to severe symptoms > 15 minutes. Epidural steroid treatment within the last three months History of drug or alcohol dependence Serious intercurrent illness Hypersensitivity to oxymorphone hydrochloride Hypersensitivity to propoxyphene or acetaminophen Severe bronchial asthma or hypercarbia, morphine analogs such as codeine, or any of the other ingredients of Opana Suspicion of paralytic ileus Moderate or severe hepatic impairment Major conduction abnormality on ECG or cardiac (Bruce protocol) stress test within the past year. Ongoing treatment with a long-acting opioid or regularly-scheduled use of a short acting opioid (>3 doses/day on four or more days/week).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Markman, M.D.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
2180 S. Clinton Ave
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17552065
Citation
Simon LS, Evans C, Katz N, Bombardier C, West C, Robbins J, Copley-Merriman C, Markman J, Coombs JH. Preliminary development of a responder index for chronic low back pain. J Rheumatol. 2007 Jun;34(6):1386-91.
Results Reference
background
PubMed Identifier
16427000
Citation
Markman JD, Dworkin RH. Ion channel targets and treatment efficacy in neuropathic pain. J Pain. 2006 Jan;7(1 Suppl 1):S38-47. doi: 10.1016/j.jpain.2005.09.008.
Results Reference
background
PubMed Identifier
11040847
Citation
Deen HG Jr, Zimmerman RS, Lyons MK, McPhee MC, Verheijde JL, Lemens SM. Test-retest reproducibility of the exercise treadmill examination in lumbar spinal stenosis. Mayo Clin Proc. 2000 Oct;75(10):1002-7. doi: 10.4065/75.10.1002.
Results Reference
background
PubMed Identifier
9474733
Citation
Deen HG, Zimmerman RS, Lyons MK, McPhee MC, Verheijde JL, Lemens SM. Use of the exercise treadmill to measure baseline functional status and surgical outcome in patients with severe lumbar spinal stenosis. Spine (Phila Pa 1976). 1998 Jan 15;23(2):244-8. doi: 10.1097/00007632-199801150-00019.
Results Reference
background
PubMed Identifier
8779009
Citation
Stucki G, Daltroy L, Liang MH, Lipson SJ, Fossel AH, Katz JN. Measurement properties of a self-administered outcome measure in lumbar spinal stenosis. Spine (Phila Pa 1976). 1996 Apr 1;21(7):796-803. doi: 10.1097/00007632-199604010-00004.
Results Reference
background
PubMed Identifier
25705958
Citation
Markman JD, Gewandter JS, Frazer ME, Murray NM, Rast SA, McDermott MP, Chowdhry AK, Tomkinson EJ, Pilcher WH, Walter KA, Dworkin RH. A Randomized, Double-blind, Placebo-Controlled Crossover Trial of Oxymorphone Hydrochloride and Propoxyphene/Acetaminophen Combination for the Treatment of Neurogenic Claudication Associated With Lumbar Spinal Stenosis. Spine (Phila Pa 1976). 2015 May 15;40(10):684-91. doi: 10.1097/BRS.0000000000000837.
Results Reference
derived

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Lumbar Stenosis Outcomes Research II

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