Montefiore Medical Center
The Bronx, New York, 10467, United States
Location status: Recruiting
NCT Number: NCT05851976
This research study will help determine whether a medication called duloxetine can improve back pain. It is well documented that many participants who come to the ER with acute low back pain still have low back pain 3 months later. The investigator team will attempt to determine whether duloxetine can help prevent this.
Interested in participating?
Request Info18 year–64 year
All sexes
Interventional
Phase 4
The Bronx, New York, 10467, United States
Location status: Recruiting
Participants will be eligible to take duloxetine/placebo if insufficient relief of pain after using naproxen for 48 hours has been reported.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PHQ9 score >4. Now we would like to exclude patients with a PHQ9 score >10 or symptoms of feeling down, depressed, or hopeless
Naproxen 500mg twice daily for 16 days
Duloxetine 60mg daily for 14 days
Time frame: 16 days, 42 days and 84 days after ED discharge
An ordinal pain scale ("severe", "moderate", "mild", or "none") will be used to assess LBP. Study participants will be asked to describe their worst back pain over the previous 24 hours. The number of patients reporting with "Moderate" or "Severe" pain will be summarized by study arm.
Time frame: 9 days, 16 days, 23 days, and 42 days after Emergency Department (ED) discharge
The Roland Morris Disability Questionnaire (RMDQ) will be used to assess the number of participants experiencing LBP over the prior 24-hour period. Items on the 24-item functional scale are scored 0 if left blank or 1 if endorsed, for a total Roland Morris score ranging from 0-24. Group scores will be summarized by study arm using basic descriptive statistics. Higher scores represent higher levels of pain-related disability.
Time frame: 9 days, 16 days, 23 days, and 42 days after ED discharge
Frequency of LBP will be assessed by the response to the question, "Over the last 24 hours, how often were you in pain?" Response options on the questionnaire will be limited to "Not at all," "Rarely," " Sometimes," "Usually," or "Always." Since LBP symptomatology is quite variable, this question will help determine the burdensomeness of LBP on the patient's daily life. Responses will be summarized and reported by study arm.
Time frame: 9 days, 16 days, 23 days, and 42 days after ED discharge
The number of visits to any healthcare provider since the prior visit will be summarized by study arm using basic descriptive statistics by study arm. Visits can include any visit to a primary, secondary, or tertiary healthcare provider.
Time frame: 9 days, 16 days, 23 days, and 42 days after ED discharge
Number of participants demonstrating depressive symptoms over the prior 2 week period will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). The PHQ-9 is an instrument used for the screening, diagnosing, monitoring, and measuring the severity of depression. Responses to the 9 questions are based on 4-point Likert-like scale ranging from 0 ("Not at all") to 3 ("Nearly every day") for an overall possible scoring range of 0-27. Higher scores are associated with increased depressive symptoms. Scores will be summarized by study arm using basic descriptive statistics.
Time frame: 9 days, 16 days, 23 days, and 42 days after ED discharge
The number of patients reporting satisfaction will be assessed by the response to the question, "The next time you go to the ER with LBP back do you want to get the same combination of medications?" Responses will be summarized by study arm using basic descriptive statistics.
Contact information is provided by the study sponsor or research team.
Montefiore Medical Center
Other
Duloxetine for Patients With Low Back Pain Who Fail to Improve With Oral NSAIDs. A Randomized Placebo-controlled Exploratory Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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