Efficacy of Pregabalin in Patients With Radicular Pain
Completed · Phase 4 · Has a placebo group
Conditions studied: Neuropathy; Radicular, Lumbar, Lumbosacral, Failed Back Surgery Syndrome, Spinal Stenosis, Herniated Disc
In brief
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.
Key facts
- Study ID
- NCT00908375
- Run by
- Northwestern University
- People needed
- 39
- Starts
- 2009-05-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2014-10-13
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Pain Medicine Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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