Phase 4
N=39
Efficacy of Pregabalin in Patients With Radicular Pain
Neuropathy; Radicular, Lumbar, Lumbosacral · Failed Back Surgery Syndrome · Spinal Stenosis · Herniated Disc
Bottom Line
View on ClinicalTrials.gov: NCT00908375 ↗Enrolled (actual)
39
Serious AEs
7.7%
Results posted
Sep 2014
Primary outcome: Primary: Pain Scores (NRS) at 3-weeks — 6; 3 units on a scale — p=0.279
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pregabalin (Drug); Sugar Pill (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Scores (NRS) at 3-weeks |
6; 3 | 0.279 |
| SECONDARY Patient's Global Impression of Change at 3 Weeks |
3.5; 3 | 0.282 |
| SECONDARY Oswestry Disability Questionnaires |
41; 20 | 0.139 |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00908375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.