Efficacy of Pregabalin in Patients With Radicular Pain

Condition(s) targeted: Lumbar Radicular Pain; Failed Back Surgery Syndrome; Spinal Stenosis; Herniated Disc

Intervention: Pregabalin (Drug); Sugar Pill (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Northwestern University

Official(s) and/or principal investigator(s):
Khalid M Malik, MD, Principal Investigator, Affiliation: Northwestern University

Overall contact:
Khalid M Malik, MD, Phone: 312-926-8369, Email: k-malik@northwestern.edu

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: Overall change in pain scores

Secondary outcome:

Global impression of change in patient status

Oswestry and Roland-Morris disability questionnaires

Standard morphine equivalents of analgesic medications used

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

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.

Khalid M Malik, MD, Phone: 312-926-8369, Email: k-malik@northwestern.edu

Pain Medicine Center, Chicago, Illinois 60610, United States; Recruiting
Khalid M Malik, MD, Phone: 312-926-8369, Email: k-malik@northwestern.edu
Khalid M Malik, MD, Principal Investigator

Starting date: May 2009
Last updated: March 13, 2012