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Efficacy of Pregabalin in Patients With Radicular Pain

Primary Purpose

Neuropathy; Radicular, Lumbar, Lumbosacral, Failed Back Surgery Syndrome, Spinal Stenosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pregabalin
Sugar Pill
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathy; Radicular, Lumbar, Lumbosacral focused on measuring Pregabalin, Radicular pain, Failed back surgery, Of greater than 3 months duration

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pain Medicine Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pregabalin

Surgar Pill

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient's Global Impression of Change at 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
Oswestry Disability Questionnaires
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.

Full Information

First Posted
May 21, 2009
Last Updated
October 2, 2014
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT00908375
Brief Title
Efficacy of Pregabalin in Patients With Radicular Pain
Official Title
Efficacy of Pregabalin in Patients With Radicular Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Surgar Pill
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica®, Pfizer NY, NY 10017
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sugar Pill
Other Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Scores (NRS) at 3-weeks
Description
Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment. .
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Patient's Global Impression of Change at 3 Weeks
Description
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
Time Frame
3 weeks
Title
Oswestry Disability Questionnaires
Description
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.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid M Malik, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain Medicine Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States

12. IPD Sharing Statement

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Efficacy of Pregabalin in Patients With Radicular Pain

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