Duloxetine for LBP
ConditionBack Pain, Low
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-64
SponsorMontefiore Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Present to Emergency Department (ED) primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.
Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the ED visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal LBP.
Patient is to be discharged home. Patients admitted to the hospital are more likely to be treated with parenteral medication and therefore are not appropriate for this study.
Age 18-64 Enrollment will be limited to adults younger than 65 years because of the increased risk of adverse medication effects in older patients.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Naproxen
DrugNaproxen 500mg twice daily for 16 days
Duloxetine
DrugDuloxetine 60mg daily for 14 days
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Naproxen + duloxetineExperimental treatment 2 interventions
Group B: Naproxen + placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
16 days, 42 days and 84 days after ED dischargeSecondary outcomes
1
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.
Time frame
9 days, 16 days, 23 days, and 42 days after Emergency Department (ED) discharge2
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.
Time frame
9 days, 16 days, 23 days, and 42 days after ED discharge3
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.
Time frame
9 days, 16 days, 23 days, and 42 days after ED discharge4
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.
Time frame
9 days, 16 days, 23 days, and 42 days after ED dischargeSponsors and contacts
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Source ClinicalTrials.gov