Ignite Creation Date:
2024-05-05 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00638443
Status:
COMPLETED
Last Update Posted:
2016-06-20
First Post:
2008-03-12
Brief Title:
Lumbar Stenosis Outcomes Research LUSTOR
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Lumbar Stenosis Outcomes Research LUSTOR- A Randomized Double-blind Cross-over Trial of Pregabalin vs Diphenhydramine in Patients With Lumbar Spinal Stenosis and Neuropathic Low Back Pain
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUSTOR
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 patients with 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 pregabalin with respect to improvement in duration and distance of walking
Detailed Description:
Subjects were randomized into one of two treatment sequences pregabalinactive placebo or active placebopregabalin Each arm lasted 10 days with a washout period of 10 days between treatments Pregabalin was administered as a standardized two step titration starting at 75mg twice daily up to a maximum daily dose of 150mg twice daily and likewise diphenhydramine active placebo was administered starting at 625mg twice daily up to a maximum daily dose of 125mg twice daily The primary endpoint was time to first symptoms of moderate intensity NRS 410 during treadmill ambulation Ambulation assessment was performed during the screening visit and on day 10 of each period 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 12 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IIRGA00818X | OTHER | Sponsor ID | None |