Lumbar Stenosis Outcomes Research II

• Status: Terminated
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: Endo Pharmaceuticals
• Treatments: Acetaminophen; Acetaminophen, dextropropoxyphene, drug combination; Dextropropoxyphene; Levopropoxyphene; Oxymorphone

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).