Effect of Milnacipran in Chronic Neuropathic Low Back Pain

Phase 2

Completed

Brief Summary: Low back pain is a public health problem affecting between 70-85% of adults at some time in their life. This study is being done to study the safety and effectiveness of the drug Milnacipran in treating chronic low back pain.

Detailed Description: This exploratory study aims to evaluate Milnacipran in individuals with chronic neuropathic low back pain. A sample of 40 individuals with chronic low back pain will be enrolled in a double-blind, randomized, parallel group study comparing twice daily administration of milnacipran with placebo (total 100 mg bid-or equivalent placebo dosing). The study will last 6 weeks with subjects being evaluated at the start of the study, at the end of a one-week drug-free period, and at 1, 2 and 6 weeks of treatment. Additionally, subjects will evaluated after treatment has ended. Both standard endpoint outcome measures as well as validated daily self-report measures of pain and activity/disability will be utilized.

Recruitment & Eligibility

Inclusion Criteria

History of low back pain for a minimum of 6 months with radiation to leg or buttocks
Over 18 years of age and under 70
Must have a visual analogue scale (VAS) pain score >50mm
Must be in generally stable health
Must be willing to abstain from alcohol during the course of the study
If female, must be post-menopausal, or practicing a highly effective method of contraception or abstinence during the course of the study
Must be able to read and understand instructions and the questionnaires
Must be willing to participate in daily data collection requirements via telephone (IVRS)
Must understand all aspects of the study, and willing to sign an informed consent form in that regard.

Exclusion Criteria

Low back pain associated with systemic signs or symptoms (e.g. fever or chills)
Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of surgery or tumor in the back
Involvement in litigation regarding back pain or other disability claim, or receiving workmen's compensation, or seeking either as a result of low back pain.
Neurological disorder including history of seizures
Major psychiatric disorder during the past six months
Active suicidal ideation or recent suicidal behavior
Significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease or malignancy
Significant renal disease or severe renal insufficiency
History of, or current, substance abuse/dependence
Significantly abnormal laboratory values
Pregnant or lactating any time during the course of the study
Known sensitivity to Savella or other SNRI
Glaucoma
Taking any MAOI, sibutramine, digoxin, tricyclic antidepressants, other SNRI, Opioids.
Beck Depression Inventory Score >30
Current Sleep Disorder

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Milnacipran	Milnacipran	milnacipran 50 mg bid; can be increased to 100 mg bid

Primary Outcome Measures

Name	Time	Method
Effect Size of VAS Pain	6 weeks from baseline	Effect size (ES) calculation for VAS pain between milnacipran and placebo groups' ES is dimensionless; Visual analogue scale (VAS) measured pain in integral units from 0 (low end) to 100 (high end); ES (Cohen's d) is a well described statistical construct and is calculated from the difference between the means (determined at baseline and 6 weeks here) divided by the pooled standard deviation. This is the primary outcome measure.

Secondary Outcome Measures