Efficacy of Pregabalin in Patients With Radicular Pain

Northwestern University

Status and phase: Completed; Phase 4

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

Treatments: Drug: Pregabalin; Drug: Sugar Pill

Study type: Interventional

Funder types: Other

Identifiers

NCT00908375

FRA7057

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 2 patient groups, including a placebo group

Pregabalin

Active Comparator group

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.

Treatment:

Drug: Pregabalin

Surgar Pill

Placebo Comparator group

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.

Treatment:

Drug: Sugar Pill