Status:
COMPLETED
Lumbar Stenosis Outcomes Research (LUSTOR)
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Pfizer
Conditions:
Lumbar Spinal Stenosis
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
The primary objective of the proposed pilot study is to determine the efficacy of pregabalin in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patien...
Detailed Description
Subjects were randomized into one of two treatment sequences: pregabalin/active placebo or active placebo/pregabalin. Each arm lasted 10 days, with a washout period of 10 days between treatments. Preg...
Eligibility Criteria
Inclusion
- Patients must present with 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) and endorse limitation of walking tolerance due to these symptoms
- Numeric Rating Scale (NRS) for pain greater than or equal to 6 in response to the following questions: "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
- Past or present existence of movement disorder, e.g., Parkinsonism,or a 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
- Prior treatment with study drug for neurogenic claudication
- Severe psychiatric disorder
- Mean time to severe symptoms \> 15 minutes.
- Epidural steroid treatment within the last three months
- Ongoing treatment with gabapentin
- Hypersensitivity or allergic reaction to diphenhydramine
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00638443
Start Date
March 1 2008
End Date
September 1 2010
Last Update
June 20 2016
Active Locations (1)
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1
2180 South Clinton Avenue
Rochester, New York, United States, 14618