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

NCT03315533 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: RhodeIslandH
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Self-reported axial pain (0 - 10 numeric rating scale)

  Moderate to severe axial muscoloskeletal pain was chosen as the primary outcome because it is associated with risk for chronic pain development and because it of its clinical relevance. Investigators will asses if there is a decrease in persistent musculoskeletal pain incidence and severity 6 weeks after the ED visit.

  through 6 weeks after enrollment visit

Study Arms (3)

Duloxetine 30 milligrams (mg)

EXPERIMENTAL

Drug: Duloxetine 30 milligrams (MG)

Placebo

PLACEBO COMPARATOR

Drug: Placebo Oral Tablet

Duloxetine 60 milligrams (mg)

EXPERIMENTAL

Drug: Duloxetine 60 milligrams (MG)

Interventions

Duloxetine 30 milligrams (MG) DRUG

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

Duloxetine 30 milligrams (mg)

Duloxetine 60 milligrams (MG) DRUG

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

Duloxetine 60 milligrams (mg)

Placebo Oral Tablet DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Mayday Fund: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

• Beaudoin FL, Gaither R, DeLomba WC, McLean SA. Tolerability and efficacy of duloxetine for the prevention of persistent musculoskeletal pain after trauma and injury: a pilot three-group randomized controlled trial. Pain. 2023 Apr 1;164(4):855-863. doi: 10.1097/j.pain.0000000000002782. Epub 2022 Sep 15.

  PMID: 36375173 DERIVED

• Strauss DH, Santhanam DR, McLean SA, Beaudoin FL. Study protocol for a randomised, double-blind, placebo-controlled clinical trial of duloxetine for the treatment and prevention of musculoskeletal pain: altering the transition from acute to chronic pain (ATTAC pain). BMJ Open. 2019 Mar 5;9(3):e025002. doi: 10.1136/bmjopen-2018-025002.

  PMID: 30842115 DERIVED

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 20, 2017
• Study Start: January 19, 2018
• Primary Completion: March 25, 2019
• Study Completion: April 1, 2019
• Last Updated: July 8, 2020

Record last verified: 2018-12

Locations

US (1)