Clinical trial NCT00908375: Efficacy of Pregabalin in Patients With Radicular Pain
Official title: Efficacy of Pregabalin in Patients With Radicular Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuropathy; Radicular, Lumbar, Lumbosacral
Failed Back Surgery Syndrome
Spinal Stenosis
Herniated Disc
Keywords: Pregabalin
Radicular pain
Failed back surgery
Of greater than 3 months duration
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-05-25
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 surgery syndrome.

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.

Eligibility 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.

Primary outcomes:
measure: Pain Scores (NRS) at 3-weeks
timeFrame: 3 weeks
Secondary outcomes:
measure: Patient's Global Impression of Change at 3 Weeks
timeFrame: 3 weeks
measure: Oswestry Disability Questionnaires
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Pain Medicine Center
state: Illinois
Study officials:
affiliation: Northwestern University
name: Khalid M Malik, MD
role: PRINCIPAL_INVESTIGATOR
References: