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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

Status: Completed

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.

Clinical Details

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

Secondary outcome:

Patient's Global Impression of Change at 3 Weeks

Oswestry Disability Questionnaires

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 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. Gender(s): Both.


Inclusion Criteria: 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. Exclusion Criteria: 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 wheezing). 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®, Actos®). 13. Pregnant patients.

Locations and Contacts

Pain Medicine Center, Chicago, Illinois 60610, United States
Additional Information

Starting date: May 2009
Last updated: October 2, 2014

Page last updated: August 23, 2015

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