Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT00652093
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00652093
Study Brief:
Protocol Section:
NCT00652093