Lumbar Stenosis Outcomes Research II
Condition: Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
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
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.; 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.
Intervention MeSH terms: Acetaminophen; Oxymorphone; Acetaminophen, dextropropoxyphene, drug combination; Dextropropoxyphene; Levopropoxyphene
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

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.
    

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).