Low Back Pain
Conditions
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.
Interventions
DRUGMilnacipran
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.
DRUGPlacebo
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.
Sponsors
Forest Laboratories
Shirley Ryan AbilityLab
Best Practice
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Outpatient clinic
Pre-assignment details
Screening visit prior to randomization
Participants by arm
| Arm | Count |
|---|---|
| Milnacipran Milnacipran : 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. | 20 |
| Placebo Placebo treatment group | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Placebo | Milnacipran | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Continuous | 48.3 years STANDARD_DEVIATION 9.1 | 47.1 years STANDARD_DEVIATION 11.6 | 47.7 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 20 | 10 / 20 |
| serious Total, serious adverse events | 0 / 20 | 1 / 20 |
Outcome results
Primary
Effect Size of VAS Pain
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.
Time frame: 6 weeks from baseline
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Effect Size of VAS Pain | 24.8 units on a scale | Standard Deviation 32.5 |
| Milnacipran | Effect Size of VAS Pain | 31.3 units on a scale | Standard Deviation 26.4 |
Comparison: effect size is endpoint and not comparisoneffect size is endpoint and not comparis