Altering The Transition From Acute to Chronic Pain (ATTAC-Pain)

There is an urgent need for new non-opioid pain management options to prevent the development
of chronic musculoskeletal pain in patients experiencing acute pain and injury. Investigators
propose to address this unmet need by intervening at the point when pain is still acute with
pain management that is intended to alter the mechanisms involved in the transition from
acute to chronic pain. The proposed study, "Altering The Transition from Acute to Chronic
Pain (ATTAC-Pain): A randomized clinical trial of duloxetine for the treatment and prevention
of musculoskeletal pain," will examine the ability of duloxetine to improve pain outcomes in
individuals presenting to the emergency department (ED) with acute musculoskeletal pain.
Investigators will enroll a total of sixty participants. Eligible patients who consent to the
study will: be randomized in the ED, receive a dose of study drug (duloxetine 30mg,
duloxetine 60mg, or placebo) in the ED, and be discharged from the ED with a two week supply
of study drug. Following discharge, the patient will receive follow-up assessments via
internet-based surveys and phone to monitor for adverse events and evaluate patient outcomes.
The patient will also return to the study site for an in-person follow-up interview 6 weeks
after their initial ED visit. The study team will recruit participants at the Rhode Island
Hospital and the Miriam Hospital EDs. The results of this study will be used as basis for a
potentially high impact large-scale trial examining an important new 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 sequelae, and decrease health care
costs.

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