Pain Medicine Center
Chicago, Illinois, 60610, United States
NCT Number: NCT00908375
The purpose of this study is to evaluate whether pregabalin is effective in reducing the pain in patients who present with radicular pain due to a herniated disc, spinal stenosis or failed back surgery syndrome.
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Notify Me18 year–64 year
All sexes
Interventional
Phase 4
Chicago, Illinois, 60610, United States
Although the efficacy of pregabalin has been demonstrated in several pain states and it is approved by the FDA for use in post herpetic neuralgia, diabetic neuropathy and fibromyalgia there are few studies of its efficacy in patients with radicular pain from herniated disc, spinal stenosis or failed back surgery syndrome. This study was conducted to evaluate the efficacy of pregabalin in these pain states.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
Other names: Lyrica®, Pfizer NY, NY 10017
One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.
Other names: Placebo
Time frame: 3 weeks
Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment.
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Time frame: 3 weeks
Global impression of change in patient status reported at 3 weeks. The global impression of change consists of a Likert scale as below:
Time frame: 3 weeks
Oswestry disability index (ODI) is a tool to measure a subject's functional disability. The Oswestry disability index consists of 10 questions with a Likert 0-5 scale. Each individual score is converted into a percent which represents the "percent disability." There are five tiers, 0-20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled), 81%-100% (i.e. bed bound). We report the Oswestry disability scores at 3 weeks.
Northwestern University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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