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

NCT ID: NCT03315533

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-19
• Study Completion Date: 2019-04-01

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.

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.

Conditions

Musculoskeletal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Duloxetine 30 milligrams (mg)

Group Type: EXPERIMENTAL

Duloxetine 30 milligrams (MG)

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: 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)

Group Type: EXPERIMENTAL

Duloxetine 60 milligrams (MG)

Intervention Type: 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

Interventions

Duloxetine 30 milligrams (MG)

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 Type: DRUG

Duloxetine 60 milligrams (MG)

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 Type: DRUG

Placebo Oral Tablet

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 Type: DRUG

Eligibility Criteria

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 injuryâ€
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayday Fund

OTHER

Sponsor Role: collaborator

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36375173 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30842115 (View on PubMed)

Other Identifiers

RhodeIslandH

Identifier Type: -

Identifier Source: org_study_id