Efficacy of Pregabalin in Patients With Radicular Pain
This study has been completed.
Information provided by (Responsible Party):
kahlid malik, Northwestern University
First received: May 21, 2009
Last updated: October 2, 2014
Last verified: September 2014
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.
Neuropathy; Radicular, Lumbar, Lumbosacral
Failed Back Surgery Syndrome
Drug: Sugar Pill
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
||Efficacy of Pregabalin in Patients With Radicular Pain
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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:
- Very Much Improved
- Much Improved
- Minimally Improved
- No Change
- Minimally Worse
- Much Worse
- Very Much Worse
- 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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2012 (Final data collection date for primary outcome measure)
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.
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
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.
|Ages Eligible for Study:
||18 Years to 64 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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
|Pain Medicine Center
|Chicago, Illinois, United States, 60610 |
||Khalid M Malik, MD
||kahlid malik, Assistant Professor of Anesthesiology, Northwestern University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 21, 2009
|Results First Received:
||May 29, 2014
||October 2, 2014
Keywords provided by kahlid malik, Northwestern University:
Failed back surgery
Of greater than 3 months duration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 21, 2017
Failed Back Surgery Syndrome
Intervertebral Disc Displacement
Nervous System Diseases
Signs and Symptoms
Pathological Conditions, Anatomical
Peripheral Nervous System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Central Nervous System Depressants