The purpose of this study is to evaluate the effect of milnacipran on how the brain processes pain in patients with fibromyalgia and to assess the relationship between this effect and brain activation patterns during functional magnetic resonance imaging.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2
Twice daily oral administration of Milnacipran for 5 weeks.
Twice daily oral administration of placebo for 5 weeks.
Twice daily oral administration of placebo for 5 weeks.
Forest Investigative Site
Ann Arbor, Michigan, United States
Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.
Pain intensity is rated using the Gracely Box Scale, where 0 is no pain sensation and 20 is extremely intense. Painful blunt pressure is applied to the thumbnail of the patient's left hand. A software system will determine medium(rated as 7 or 8) and high pain (rated as 13 or 14) thresholds at baseline, week 5 and at a second baseline at week 7 and week 12.
Time frame: Week 0, 5, 7 and 12
Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.
DNIC is evaluated using a conditioning stimulus and a test stimulus. Painful blunt pressure is applied to the thumbnail of the patient's left hand for 30 sec. Patient rates pain experienced on numerical scale of 0(no pain) to 100(worst pain) at 10, 20 \& 30 sec. This is repeated 3 times and a mean pain score is calculated. 5 minutes following test stimulus, patient's right hand is immersed in 12C water at 30 sec test stimulus is reapplied and a 2nd mean pain score is calculated. The difference in mean pain rating before and after conditioning stimulus indicates presence and magnitude of DNIC
Time frame: Weeks 0, 5, 7 and 12
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Twice daily oral administration of Milnacipran for 5 weeks.