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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.
Participants will be eligible to take duloxetine/placebo if insufficient relief of pain after using naproxen for 48 hours has been reported.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naproxen + duloxetine | Experimental |
| |
| Naproxen + placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen | Drug | Naproxen 500mg twice daily for 16 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with moderate or severe Low Back Pain (LBP) | 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. | 16 days, 42 days and 84 days after ED discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants experiencing LBP based on the Roland Morris Disability Questionnaire (RMDQ) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Not available for follow-up
Pregnant or breast-feeding
Chronic pain syndrome defined as moderate or severe pain anywhere in their body on >= 50% of days for at least three months
Allergic to or intolerant of investigational medications
Contra-indications to non-steroidal anti-inflammatory drugs:
Contra-indication to duloxetine:
PHQ9 score >4. Now we would like to exclude patients with a PHQ9 score >10 or symptoms of feeling down, depressed, or hopeless
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Friedman, MD | Contact | 718-920-6626 | befriedm@montefiore.org |
| Name | Affiliation | Role |
|---|---|---|
| Benjamin Friedman, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Duloxetine | Drug | Duloxetine 60mg daily for 14 days |
|
| 9 days, 16 days, 23 days, and 42 days after Emergency Department (ED) discharge |
| Frequency of LBP | 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. | 9 days, 16 days, 23 days, and 42 days after ED discharge |
| Number of visits to a healthcare provider | 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. | 9 days, 16 days, 23 days, and 42 days after ED discharge |
| The number of patients experiencing Depressive Symptoms | 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. | 9 days, 16 days, 23 days, and 42 days after ED discharge |
| The number of patients reporting Satisfaction with treatment | 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. | 9 days, 16 days, 23 days, and 42 days after ED discharge |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |