This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Chronic low back pain (CLBP) is a very common and expensive health problem for people in the United States and the world. However, little is known about the precise cause of CLBP. Many studies of CLBP have shown that specific causes of CLBP (for example an injury, strain or ruptured disc) do not explain the symptoms in a large number of individuals. We have collected data that indicates that some individuals with CLBP may have pain not because of damage in the back, but instead because of the way their brain is processing pain. This problem is similar to that seen in individuals with other chronic pain syndromes such as fibromyalgia, irritable bowel syndrome (IBS), and temporomandibular disorders (TMD). We will ask 160 individuals with chronic low back pain to participate in this 14-week study to examine a possible alternate cause of chronic low back pain. Research activities include completing self-report forms about different symptoms (pain, fatigue, mood, etc); monitoring these symptoms real-time with a watch-like activity monitor and Palm'-based electronic diary; evoked pain testing via pressure applied to the thumbnail; functional imaging (fMRI) with thumb pressure testing to look at pain processing in the brain; monitoring changes in heart rate; and collecting saliva for cortisol (hormone) analysis. Additionally, this research will involve three drugs (amitriptyline, mirtazepine and zonasimide) that are FDA approved and known to improve pain in syndromes such as fibromyalgia. Individuals whose CLBP may be due to pain processing in the brain, rather than damage in the back, might also experience improvements in their pain symptoms while using this drug. Individuals in this study will be assigned, at random, to receive study drug(s) or a placebo (diphenhydramine hydrochloride; trade name: Benadryl) in a double-blind fashion: neither the researchers nor the individuals will know who is taking drug and who is taking placebo until the end of the study. Following 2 weeks of collecting symptoms daily at home, individuals will begin taking the drug or placebo as instructed for the remaining 12 weeks of the study. If our theory is true, it would fundamentally change the way in which chronic low back pain patients should be evaluated and treated. This research will also add insight into effective and efficient means of measuring pain, obtaining accurate pain ratings from individuals, and evaluating pain processing.'
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