Altering The Transition From Acute to Chronic Pain (ATTAC-Pain)
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Chronic Pain
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.
    

Intervention name(s): Duloxetine 30 milligrams (MG); Duloxetine 60 milligrams (MG); Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once a patient's history and screening results have been cleared by a physician investigator, the participant will be randomized by the study site investigational drug services (IDS) to receive duloxetine (30mg or 60mg) vs. placebo; Once a patient's history and screening results have been cleared by a physician investigator, the participant will be randomized by the study site investigational drug services (IDS) to receive duloxetine (30mg or 60mg) vs. placebo; Once a patient's history and screening results have been cleared by a physician investigator, the participant will be randomized by the study site investigational drug services (IDS) to receive duloxetine (30mg or 60mg) vs. placebo
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment