Status:
COMPLETED
Efficacy of Pregabalin in Patients With Radicular Pain
Lead Sponsor:
Northwestern University
Conditions:
Neuropathy; Radicular, Lumbar, Lumbosacral
Failed Back Surgery Syndrome
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
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 surger...
Detailed Description
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 st...
Eligibility Criteria
Inclusion
- Patients with pain in dermatomal distribution, in either cervical or lumbar region.
- History of pain for more than 3 months.
- History of herniated disc, spinal stenosis or failed back surgery.
- A series of epidural steroid injections within the past 6 months.
- Presence of motor or sensory neurological signs (hypoesthesia, hyperesthesia, allodynia, dysesthesia) in the affected dermatomes.
- Patients must be cognitively capable of completing the pain questionnaires.
Exclusion
- Patients below 18 or over 65 years of age.
- Patients with mostly axial spinal pain.
- Presence of significant motor deficits, and /or bowel and/or bladder dysfunction.
- Workmen's compensation or disability issues.
- Patients with chronic depression and on depression medications.
- Addiction and/or substance abuse issues.
- Patients using gabapentin or failure to respond to previous gabapentin use.
- Patients with known peripheral neuropathy (e.g. DPN, PHN etc.).
- Known hypersensitivity to pregabalin use (hives, blisters, rash, dypnea and wheezing).
- History of angioedema with pregabalin use.
- Patients with known renal insufficiency, diabetes, congestive heart failure, cardiac conduction abnormalities, and/or thrombocytopenia.
- Patients using ACE-inhibitors and thiazolidinedione antidiabetic agents (Avandia®, Actos®).
- Pregnant patients.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00908375
Start Date
May 1 2009
End Date
December 1 2012
Last Update
October 13 2014
Active Locations (1)
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1
Pain Medicine Center
Chicago, Illinois, United States, 60610