Efficacy of Pregabalin in Patients With Radicular Pain

NCT ID: NCT00908375

Last Updated: 2014-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Sugar Pill

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Lyrica®, Pfizer NY, NY 10017; Placebo

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

kahlid malik

Assistant Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khalid M Malik, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Pain Medicine Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

FRA7057

Identifier Type: -

Identifier Source: org_study_id