Efficacy of Pregabalin in Patients With Radicular Pain
Information source: Northwestern University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuropathy; Radicular, Lumbar, Lumbosacral; Failed Back Surgery Syndrome; Spinal Stenosis; Herniated Disc
Intervention: Pregabalin (Drug); Sugar Pill (Drug)
Phase: Phase 4
Sponsored by: Northwestern University
Official(s) and/or principal investigator(s):
Khalid M Malik, MD, Principal Investigator, Affiliation: Northwestern University
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.
Official title: Efficacy of Pregabalin in Patients With Radicular Pain
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Pain Scores (NRS) at 3-weeks
Patient's Global Impression of Change at 3 Weeks
Oswestry Disability Questionnaires
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.
Minimum age: 18 Years.
Maximum age: 64 Years.
1. Patients with pain in dermatomal distribution, in either cervical or lumbar region.
2. History of pain for more than 3 months.
3. History of herniated disc, spinal stenosis or failed back surgery.
4. A series of epidural steroid injections within the past 6 months.
5. Presence of motor or sensory neurological signs (hypoesthesia, hyperesthesia,
allodynia, dysesthesia) in the affected dermatomes.
6. Patients must be cognitively capable of completing the pain questionnaires.
1. Patients below 18 or over 65 years of age.
2. Patients with mostly axial spinal pain.
3. Presence of significant motor deficits, and /or bowel and/or bladder dysfunction.
4. Workmen's compensation or disability issues.
5. Patients with chronic depression and on depression medications.
6. Addiction and/or substance abuse issues.
7. Patients using gabapentin or failure to respond to previous gabapentin use.
8. Patients with known peripheral neuropathy (e. g. DPN, PHN etc.).
9. Known hypersensitivity to pregabalin use (hives, blisters, rash, dypnea and
10. History of angioedema with pregabalin use.
11. Patients with known renal insufficiency, diabetes, congestive heart failure, cardiac
conduction abnormalities, and/or thrombocytopenia.
12. Patients using ACE-inhibitors and thiazolidinedione antidiabetic agents (Avandia®,
13. Pregnant patients.
Locations and Contacts
Pain Medicine Center, Chicago, Illinois 60610, United States
Starting date: May 2009
Last updated: October 2, 2014