Efficacy of Pregabalin in Patients With Radicular Pain

October 2, 2014 updated by: kahlid malik, 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Pain Medicine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pregabalin
A 75mg pregabalin 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.
Drug: Pregabalin
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
Placebo Comparator: Surgar Pill
One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.
Drug: Sugar Pill
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. Very Much Improved
  2. Much Improved
  3. Minimally Improved
  4. No Change
  5. Minimally Worse
  6. Much Worse
  7. Very Much Worse
3 weeks
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.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Khalid M Malik, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 21, 2009

First Submitted That Met QC Criteria

May 22, 2009

First Posted (Estimate)

May 25, 2009

Study Record Updates

Last Update Posted (Estimate)

October 13, 2014

Last Update Submitted That Met QC Criteria

October 2, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRA7057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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