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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 13, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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