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

Primary Purpose

Musculoskeletal Pain

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Duloxetine 30 milligrams (MG)

Duloxetine 60 milligrams (MG)

Placebo Oral Tablet

About this trial

This is an interventional treatment trial for Musculoskeletal Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Duloxetine 30 milligrams (mg)

Placebo

Duloxetine 60 milligrams (mg)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03315533

First Posted

September 25, 2017

Last Updated

July 6, 2020

Sponsor

Rhode Island Hospital

Collaborators

Mayday Fund, National Institute of General Medical Sciences (NIGMS)

1. Study Identification

Unique Protocol Identification Number

NCT03315533

Brief Title

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

Acronym

ATTAC-PAIN

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

January 19, 2018 (Actual)

Primary Completion Date

March 25, 2019 (Actual)

Study Completion Date

April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rhode Island Hospital

Collaborators

Mayday Fund, National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Musculoskeletal Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Duloxetine 30 milligrams (mg)

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Duloxetine 60 milligrams (mg)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Duloxetine 30 milligrams (MG)

Intervention Description

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

Intervention Name(s)

Duloxetine 60 milligrams (MG)

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Intervention Description

Primary Outcome Measure Information:

Title

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

Description

Time Frame

through 6 weeks after enrollment visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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 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

Facility Information:

Facility Name

Rhode Island Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

36375173

Citation

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.

Results Reference

derived

PubMed Identifier

30842115

Citation

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.

Results Reference

derived

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

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