Efficacy of Pregabalin in Patients With Radicular Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
kahlid malik, Northwestern University
ClinicalTrials.gov Identifier:
NCT00908375
First received: May 21, 2009
Last updated: October 2, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Neuropathy; Radicular, Lumbar, Lumbosacral
Failed Back Surgery Syndrome
Spinal Stenosis
Herniated Disc
Drug: Pregabalin
Drug: Sugar Pill
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Pregabalin in Patients With Radicular Pain

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Pain Scores (NRS) at 3-weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

    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

  • Oswestry Disability Questionnaires [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 39
Study Start Date: May 2009
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908375

Locations
United States, Illinois
Pain Medicine Center
Chicago, Illinois, United States, 60610
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Khalid M Malik, MD Northwestern University
  More Information

No publications provided

Responsible Party: kahlid malik, Assistant Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT00908375     History of Changes
Other Study ID Numbers: FRA7057
Study First Received: May 21, 2009
Results First Received: May 29, 2014
Last Updated: October 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Pregabalin
Radicular pain
Failed back surgery
Of greater than 3 months duration

Additional relevant MeSH terms:
Failed Back Surgery Syndrome
Radiculopathy
Spinal Stenosis
Back Pain
Bone Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Pathologic Processes
Peripheral Nervous System Diseases
Postoperative Complications
Spinal Diseases
Gamma-Aminobutyric Acid
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014