Status:
COMPLETED
Altering The Transition From Acute to Chronic Pain (ATTAC-Pain)
Lead Sponsor:
Rhode Island Hospital
Collaborating Sponsors:
Mayday Fund
National Institute of General Medical Sciences (NIGMS)
Conditions:
Musculoskeletal Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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). Bo...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT03315533
Start Date
January 19 2018
End Date
April 1 2019
Last Update
July 8 2020
Active Locations (1)
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1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903