Efficacy of Pregabalin in Patients With Radicular Pain

This study is currently recruiting participants.

Verified March 2012 by Northwestern University

Sponsor:

Information provided by (Responsible Party):

kahlid malik, Northwestern University

ClinicalTrials.gov Identifier:

NCT00908375

First received: May 21, 2009

Last updated: March 13, 2012

Last verified: March 2012

History of Changes

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
Lumbar Radicular Pain 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:

MedlinePlus related topics: Spinal Stenosis

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Overall change in pain scores [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Global impression of change in patient status [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Oswestry and Roland-Morris disability questionnaires [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Standard morphine equivalents of analgesic medications used [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	38
Study Start Date:	May 2009
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	March 2013 (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®
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.

Eligibility

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

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.

Contacts and Locations

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

Contacts

Contact: Khalid M Malik, MD

312-926-8369

k-malik@northwestern.edu

Locations

United States, Illinois
Pain Medicine Center	Recruiting
Chicago, Illinois, United States, 60610
Contact: Khalid M Malik, MD 312-926-8369 k-malik@northwestern.edu
Principal Investigator: Khalid M Malik, MD

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
Last Updated:	March 13, 2012
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:

Spinal Stenosis
Intervertebral Disk Displacement
Failed Back Surgery Syndrome
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases

Postoperative Complications
Pathologic Processes
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on June 17, 2013

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