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Completed

NCT Number: NCT00908375

Efficacy of Pregabalin in Patients With Radicular Pain

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pregabalin

Drug

One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.

Other names: Lyrica®, Pfizer NY, NY 10017

Sugar pill

Drug

One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.

Other names: Placebo

Primary outcomes

  1. Pain Scores (NRS) at 3-weeks

    Time frame: 3 weeks

    Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment.

    .

Secondary outcomes

  1. Patient's Global Impression of Change at 3 Weeks

    Time frame: 3 weeks

    Global impression of change in patient status reported at 3 weeks. The global impression of change consists of a Likert scale as below:

    • Very Much Improved
    • Much Improved
    • Minimally Improved
    • No Change
    • Minimally Worse
    • Much Worse
    • Very Much Worse
  2. Oswestry Disability Questionnaires

    Time frame: 3 weeks

    Oswestry disability index (ODI) is a tool to measure a subject's functional disability. The Oswestry disability index consists of 10 questions with a Likert 0-5 scale. Each individual score is converted into a percent which represents the "percent disability." There are five tiers, 0-20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled), 81%-100% (i.e. bed bound). We report the Oswestry disability scores at 3 weeks.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 25, 2009
Registry last updated
Oct 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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