Pain Study to See if Ultram ER Will Provide Relief to Subjects Whose Pain is Not Well Controlled by Narcotics

You may not qualify if:

• Subject has sensory deficits at the sites of QST. Sensory deficits refer to such changes resulting from neurological diseases or medical conditions causing peripheral polyneuropathy and sensory changes, which include but are not limited to diabetes, alcoholic neuropathy, AIDS neuropathy, thyroid disease, severe liver or kidney disorders.
• Subject has scar tissue, infection, or acute injury at the sites of QST.
• Subject has had interventional procedures that may alter the results of QST. Such procedures include neuroablation (chemical or electrothermal) at any time, neuraxial (e.g., epidural) or local anesthetic block within the last eight weeks, and lumbar sympathetic or hypogastric block within the last six months. We consider eight weeks and six months as the minimal time period that must have elapsed after neuraxial injection and lumbar sympathetic block, respectively, in order to minimize the possible influence from a previous interventional procedure.
• Subject has a pending litigation related to his/her chronic pain condition.
• Subject has a history of or current seizure disorder.
• Subject has a history of severe allergic reaction to Tramadol ER or other opioid medications.
• Subject has a major psychiatric disorder (major depression; bipolar disorder; schizophrenia; anxiety disorder; psychotic disorders; eating disorders; alcohol or drug dependence; attention deficit hyperactivity disorder); subject with any known history of such conditions also will be excluded.
• Subject has severe renal impairment or severe hepatic impairment.
• Subject is using illicit drugs detected through the urine toxicology screen.
• Subject is pregnant or lactating.