Fibromyalgia Clinical Trial
Official title:
Effects of a 12 Week Milnacipran 200 mg Treatment on Pain Perception and Pain Processing in Fibromyalgia - An Open Label Study
The investigators want to study the effects of milnacipran treatment on neurotransmitter release in fibromyalgia.
Fibromyalgia (FM) is a chronic pain condition with significant morbidity. Current research
suggests a primarily central mediation of the widespread pain including central sensitization
at the spinal level and abnormal pain processing at the cerebral level. Findings in FM
patients include abnormal neurotransmitter levels in cerebrospinal fluid (CSF), abnormal
activation of cerebral pain processing areas and abnormal peripheral pain and sensory
thresholds. Continuous low level spinal cord activation by primary nociceptive afferents (C
and A delta fibers) is believed to significantly drive the central sensitization. One major
spinal neurotransmitter released by these pain fibers is substance P (SP). Several studies
have shown that FM patients have up to three times higher baseline SP levels in the CSF
compared to controls. Since spinal neurotransmitter release and therefore nociceptive
afferent activity is also regulated via a descending inhibitory pathway releasing
norepinephrine (NE) and serotonin (5HT), decreased activity of this pain modulating system
could also be involved in abnormal pain processing in FM. Indeed, there is support in the
literature for decreased CSF levels of both NE and 5HT or their metabolites. Milnacipran, a
NE and 5HT reuptake inhibitor, has been shown to potentially effectively reduce FM pain and
symptoms of FM by affecting the above pathologies.
The investigators propose an open label clinical trial with milnacipran 200 mg over 12-weeks
in order to investigate the pain pathway in FM patients at peripheral and spinal levels
before and after treatment. In addition, the investigators will assess pain intensity and
symptoms of FM before, during and after treatment. To determine if there are peripheral
effects, the investigators will characterize the systemic neurotransmitter release and their
metabolites in plasma. The investigators will also measure the heart rate variability using
an electrocardiogram to look for effects on the sympathetic nervous system.
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