Lumbar Stenosis Outcomes Research II
| Status: | Terminated |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2008 |
| End Date: | August 2011 |
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
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.
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.
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).
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).
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).
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