Please select the eligibility criteria that correspond to the clinical trial below.
Title: Altering The Transition From Acute to Chronic Pain (ATTAC-Pain): A Randomized Clinical Trial of Duloxetine for the Treatment and Prevention of Musculoskeletal Pain
Brief Summary: The current way that pain is treated after trauma and injury is problematic. Most often pain after trauma is treated with opioids (ex. Percocet® or Vicodin®) or anti-inflammatories (ex. ibuprofen). Both of these medications can cause side effects and opioids have been related to the development of addiction. In addition, there are not any treatments that prevent pain from going on to become persistent (last beyond it is supposed to) or chronic (lasting 3 months or longer).

Chronic pain is an enormous problem and there an urgent need to find both alternatives to opioid pain medications and medications that prevent pain from becoming chronic. The ATTAC-Pain (Altering The Transition from Acute to Chronic Pain) study proposes to examine whether duloxetine (a medication that is marketed for depression, anxiety, and specific types of pain conditions), can reduce acute and chronic pain among adults who come to the emergency department (ED)with muscular pain (such as neck pain after a car accident or low back pain). Investigators will enroll 60 patients who come to the ED. Patients will be eligible if they report moderate to severe muscular pain (such as pain in the back, neck, or shoulders). Consenting patients will be randomized to receive duloxetine 30mg, duloxetine 60mg, or placebo (2/3rd chance of being in one of the duloxetine groups). The study team will follow patients for six weeks and collect information on pain outcomes and use of pain medications. Investigators aim to determine if duloxetine can (1) reduce acute pain symptoms following the ED visit, (2) prevent the transition to persistent pain (having pain 6 weeks after the initial ED visit), and (3) decrease opioid use following a motor vehicle collision (MVC). The results of this study will ultimately help determine if duloxetine can be used as a non-opioid pain treatment option that reduces acute pain and prevents the transition to chronic pain. This in turn can improve recovery, reduce opioid use and its consequences, and decrease health care costs.


Options:
A: Inclusion Criteria:

* Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion Criteria:

* Psychiatric illness
* Depression
* Suicidal risk
* Substance abuse
* Pulmonary dysfunction
* Renal impairment
* Active cardiac disease
* Liver disease
* Autoimmune disease
* Cancer
* Sleep apnea
* Inflammatory bowel disease
B: Inclusion Criteria:

* Present with pain due to bilateral peripheral neuropathy

  * Participants must have pain caused by Type 1 or Type 2 diabetes mellitus
  * Pain must begin in the feet with relatively symmetrical onset
  * Daily pain should be present for at least 6 months
  * Diagnosis must be confirmed by a score of at least 3 on the Michigan Neuropathy Screening Inventory (MNSI)
* Females must test negative for a serum pregnancy test at Screening. Females of child-bearing potential (who are not surgically sterilized and between menarche and 1 year postmenopause) must agree to use a medically acceptable and reliable means of birth control, during the study and for 1 month following the last study dose.
* Stable glycemic control as assessed by a physician investigator and a glycosylated hemoglobin (HbA1c) \<12% before randomization
* Score of greater than or equal to 4 on the Brief Pain Inventory (BPI) 24-hour average pain item at Screening.
* Full completion of the daily diaries for at least 80% of the days between the second and third time you come to the hospital (Screening).

Exclusion Criteria:

* Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Current (less than or equal to 1 year) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I diagnosis of major depressive disorder, dysthymia, anxiety disorders (excluding phobias), alcohol or eating disorders as determined by the Mini-International Neuropsychiatric Interview (MINI) or a previous diagnosis
* DSM-IV diagnosis of mania, bipolar disorder, or psychosis determined either by participant history or by diagnosis using specific MNSI modules
* Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychological conditions that in the opinion of investigator would compromise participation or be likely to lead to hospitalization during the course of the study.
* At Screening alanine transaminase (ALT) greater than 2 times upper limit of normal (ULN), based on central laboratory reference ranges times ULN, based on central laboratory reference ranges
* Prior renal transplant, current renal dialysis, or serum creatinine laboratory value \>1.5 times ULN, based on central laboratory reference ranges at Screening.
* Historical exposure to drugs known to cause neuropathy, or a history of a medical condition, including pernicious anemia and hypothyroidism, that could have been responsible for neuropathy
* Pain that cannot be clearly differentiated from or conditions that interfere with the assessment of the diabetic neuropathy pain. Examples of painful conditions that could be confused with diabetic neuropathy pain include peripheral vascular disease, neurological disorders unrelated to diabetic neuropathy, skin condition in the area of the neuropathy that could alter sensation, other painful conditions
* Participants who have previously completed or withdrawn from this study or have been previously treated with duloxetine, including participants who participated in study F1J-MC-HMEQ (NCT00408993), even those in the placebo arm
* Participants taking excluded medications that cannot be stopped at Screening
* Treatment with a monoamine oxidase inhibitor (MAOI) or fluoxetine within 30 days of the third Screening
* Participants with a positive Hepatitis B surface antigen and/or Hepatitis C antibody are to be excluded if they have any of the following:

  * Hepatic dysfunction as determined by the investigator or
  * Clinical manifestations of liver disease within the previous year such as unexplained pruritus, unexplained dark urine, jaundice, unexplained right upper quadrant tenderness, unexplained "flu-like" symptoms or
  * Aspartate transaminase (AST), ALT, or bilirubin above the normal reference range.
C: Inclusion Criteria:

* generally in good health, are between the ages of 18 and 65, present to the ED with acute (present for \<7 days) musculoskeletal pain, and have a current pain score of \>4 without a history of pain in the past month.

Exclusion Criteria:

* Musculoskeletal pain lasting \> 7days
* ED pain score \<4
* Chronic pain: Pain present on most days of the week, with an average score \>1 in past month, in the same location as presenting pain
* Clinically unstable
* Fracture (except fracture of the phalanges)
* Substantial soft tissue injury†
* Hepatic failure (acute or chronic)
* Renal failure (acute or chronic)
* Coronary artery disease, including previous myocardial infarction, Angina, percutaneous transluminal coronary angioplasty, etc.
* History of glaucoma
* Previous congestive heart failure
* History of seizure disorder
* History of mania or psychotic disorder
* History of suicidal ideation
* Prisoner
* History and behavior indicates, in the investigator's judgment, that the participant would likely be noncompliant with the study
* Any other condition that, in the investigator's judgment, would indicate that the patient in unsuitable for the study (e.g. might interfere with the study, confound interpretation, or endanger patient)
* Does not have a telephone
* Does not have regular internet access and email address
* Unable to speak and read English
* Blood pressure reading(s) in ED that, when considered in the context of patient past and current history, in the investigator's judgment exceeds acceptable level
* Currently taking a monoamine oxidase inhibitor (MAOI)
* Currently taking medication with substantial interaction with duloxetine (Table 1).
* Breastfeeding
* If female, either not postmenopausal (having menses within past year), or, if childbearing potential, positive pregnancy test prior to randomization and not using a medically acceptable form of contraception
* Exceeds acceptable chronic daily opioid use prior to MVC\*
* Previously on duloxetine
* Previous allergic reaction to duloxetine
* Antidepressant use within 2 weeks of study start (4 week if Prozac)
* Allergy to lactose
* Intoxicated
D: Inclusion Criteria:

* Chronic back pain (daily pain for \> 6 months)

Exclusion Criteria:

* Major medical conditions which might contraindicate antidepressant treatment

Answer: C