Effect of Milnacipran in Chronic Neuropathic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Milnacipran; Placebo
Intervention description: Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.; 2 matching pills per day for 6 weeks. Option to increase dose after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. History of low back pain for a minimum of 6 months with radiation to leg or buttocks

          2. Over 18 years of age and under 70

          3. Must have a visual analogue scale (VAS) pain score >50mm

          4. Must be in generally stable health

          5. Must be willing to abstain from alcohol during the course of the study

          6. If female, must be post-menopausal, or practicing a highly effective method of
             contraception or abstinence during the course of the study

          7. Must be able to read and understand instructions and the questionnaires

          8. Must be willing to participate in daily data collection requirements via telephone
             (IVRS)

          9. Must understand all aspects of the study, and willing to sign an informed consent form
             in that regard.

        Exclusion Criteria:

          1. Low back pain associated with systemic signs or symptoms (e.g. fever or chills)

          2. Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
             fibromyalgia, history of surgery or tumor in the back

          3. 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.

          4. Neurological disorder including history of seizures

          5. Major psychiatric disorder during the past six months

          6. Active suicidal ideation or recent suicidal behavior

          7. Significant other medical disease such as unstable diabetes mellitus, congestive heart
             failure, coronary or peripheral vascular disease, chronic obstructive lung disease or
             malignancy

          8. Significant renal disease or severe renal insufficiency

          9. History of, or current, substance abuse/dependence

         10. Significantly abnormal laboratory values

         11. Pregnant or lactating any time during the course of the study

         12. Known sensitivity to Savella or other SNRI

         13. Glaucoma

         14. Taking any MAOI, sibutramine, digoxin, tricyclic antidepressants, other SNRI, Opioids.

         15. Beck Depression Inventory Score >30

         16. Current Sleep Disorder