Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT03315533
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03315533
Study Brief:
Protocol Section:
NCT03315533