Efficacy of Pregabalin in Patients With Radicular Pain

Spinal Stenosis Clinical Trial

Official title:

Efficacy of Pregabalin in Patients With Radicular Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908375
• Other study ID #: FRA7057
• Status: Completed
• Phase: Phase 4
• First received: May 21, 2009
• Last updated: October 2, 2014
• Start date: May 2009
• Est. completion date: December 2012

Study information

• Verified date: September 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Pain Medicine Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores (NRS) at 3-weeks	Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment.	3 weeks	No
Secondary	Patient's Global Impression of Change at 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	3 weeks	No
Secondary	Oswestry Disability Questionnaires	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.	3 weeks	No