Back Pain, LowPhase 4NCT05851976
Duloxetine for LBP
A Phase 4 study testing Naproxen and Duloxetine in people with Back Pain, Low, run by Montefiore Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Back Pain, Low
- What is being tested?
- Naproxen and Duloxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2023to May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
- Pain duration <2 weeks (336 hours).
- Prior to the acute attack of LBP, back pain cannot occur more frequently than once per week.
- Functionally impairing back pain: A baseline score of > 5 on the Roland-Morris Disability Questionnaire
Who cannot join
- 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:
- history of hypersensitivity to NSAIDs or aspirin
Show all 20Show fewer
- active or history of peptic ulcer disease, chronic dyspepsia, or active or history of gastrointestinal bleed
- Severe heart failure (NYHA 2 or worse)
- uncontrolled blood pressure (>160/100)
- Glomerular Filtration Rate (GFR) <60ml/min
- Current use of anti-coagulants
- cirrhosis or acute hepatitis
- Contra-indication to duloxetine:
- alcohol use disorder
- chronic liver disease
- chronic kidney disease
- glaucoma
- Active use of medication for depression
- Score > 10 on the Patient Health Questionnaire (PHQ-9) screening instrument or thoughts of suicide, symptoms of feeling down, depressed, or hopeless
- PHQ9 score >4. Now we would like to exclude patients with a PHQ9 score >10 or symptoms of feeling down, depressed, or hopeless
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Benjamin W Friedman, MD, 718-920-6626, befriedm@montefiore.org
About this study
Official title: Duloxetine for Patients With Low Back Pain Who Fail to Improve With Oral NSAIDs. A Randomized Placebo-controlled Exploratory Study
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.
Read the detailed description
Participants will be eligible to take duloxetine/placebo if insufficient relief of pain after using naproxen for 48 hours has been reported.
- Conditions
- Back Pain, Low
- Being tested
- Naproxen, Duloxetine
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
Naproxen 500mg twice daily for 16 days
DuloxetineDrug
Duloxetine 60mg daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Naproxen + duloxetine | Experimental | Not described Receives: Drug: Naproxen; Drug: Duloxetine |
| Naproxen + placebo | Placebo comparator | Not described Receives: Drug: Naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 days, 42 days and 84 days after ED discharge
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 days, 16 days, 23 days, and 42 days after ED discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start4 Oct 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain, LowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Friedman, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851976
- Sponsor's protocol ID
- 2023-14971
- Other IDs
- 2023
- Status last verified
- Dec 2025
- First submitted
- 1 May 2023
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duloxetine for Patients With Low Back Pain Who Fail to Improve With Oral NSAIDs. A Randomized Placebo-controlled Exploratory Study
- ClinicalTrials.gov ID
- NCT05851976
- Acronym / sponsor ID
- 2023-14971
- Conditions
- Back Pain, Low
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be eligible to take duloxetine/placebo if insufficient relief of pain after using naproxen for 48 hours has been reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naproxen + duloxetine | Experimental | Drug: Naproxen, Drug: Duloxetine |
| Naproxen + placebo | Placebo comparator | Drug: Naproxen |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
- Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
Key exclusion criteria (20 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaproxenNaproxen 500mg twice daily for 16 days | Drug | Naproxen + duloxetine, Naproxen + placebo |
| DuloxetineDuloxetine 60mg daily for 14 days | Drug | Naproxen + duloxetine |
Primary outcome
Number of participants with moderate or severe Low Back Pain (LBP)
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.
5 secondary outcomes
Number of Participants experiencing LBP based on the Roland Morris Disability Questionnaire (RMDQ)
Time frame: 9 days, 16 days, 23 days, and 42 days after Emergency Department (ED) discharge
Frequency of LBP
Time frame: 9 days, 16 days, 23 days, and 42 days after ED discharge
Number of visits to a healthcare provider
Time frame: 9 days, 16 days, 23 days, and 42 days after ED discharge
The number of patients experiencing Depressive Symptoms
Time frame: 9 days, 16 days, 23 days, and 42 days after ED discharge
The number of patients reporting Satisfaction with treatment
Time frame: 9 days, 16 days, 23 days, and 42 days after ED discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Friedman, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naproxen and Duloxetine in people with Back Pain, Low, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Friedman, MD (718-920-6626, befriedm@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with moderate or severe Low Back Pain (LBP) (time frame: 16 days, 42 days and 84 days after ED discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.