Low Back PainPhase 4NCT04611529
Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.
A Phase 4 study testing Ibuprofen 400 mg and Topical diclofenac in people with Low Back Pain, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This is a randomized, double-blind placebo-controlled study comparing two different treatments for acute low back pain: oral ibuprofen and topical diclofenac. Participants will be randomized to one of three study arms: 1) Oral ibuprofen + topical diclofenac; 2) Oral ibuprofen + topical placebo; 3) Oral placebo +… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Ibuprofen 400 mg and Topical diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2021to 30 Jun 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present to Emergency Department (ED) primary for management of Low Back Pain (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.
- Age 18-69. Enrollment will be limited to adults younger than 70 years because of the increased risk of adverse medication effects in the elderly.
- 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).
Show all 9Show fewer
- Prior to the acute attack of LBP, back pain must occur less frequently than once per month.
- Non-traumatic LBP: no substantial and direct trauma to the back within the previous month
- Functionally impairing back pain: A baseline score of > 5 on the Roland-Morris Disability Questionnaire
Who cannot join
- Not available for follow-up
- Pregnant
- Any analgesic medication use on a daily or near-daily basis
- Allergic to or intolerant of investigational medications
- Open wounds or skin breakdown of the lower back
- Contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed 2) Severe heart failure (NYHA 2 or worse) 3) Chronic kidney disease (GFR <60ml/min) 4) Current use of anti-coagulants 5) cirrhosis (Child Pugh A or worse) or hepatitis (transaminases 2x the upper limit of normal)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study of Topical Diclofenac Versus Oral Ibuprofen for Acute Non-radicular Low Back Pain
This is a randomized, double-blind placebo-controlled study comparing two different treatments for acute low back pain: oral ibuprofen and topical diclofenac. Participants will be randomized to one of three study arms: 1) Oral ibuprofen + topical diclofenac; 2) Oral ibuprofen + topical placebo; 3) Oral placebo + topical diclofenac. Outcomes will be determined at 48 hours (2 days) and 7 days later.
- Conditions
- Low Back Pain
- Being tested
- Ibuprofen 400 mg, Topical diclofenac
- 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.
Ibuprofen 400 mgDrug
Ibuprofen 400mg
Topical diclofenacDrug
Diclofenac 1% gel 4gm
| Study group | Role | What they receive |
|---|---|---|
| Oral ibuprofen + topical diclofenac | Experimental | Oral ibuprofen 400mg Topical diclofenac 4gm Receives: Drug: Ibuprofen 400 mg; Drug: Topical diclofenac |
| Oral ibuprofen + topical placebo | Active comparator | Oral ibuprofen 400mg Topical placebo Receives: Drug: Ibuprofen 400 mg |
| Oral placebo + topical diclofenac | Active comparator | Oral placebo Topical diclofenac 4gm Receives: Drug: Topical diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score
Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report 'Yes/no' instrument about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Change in RMDQ was measured by calculating: 'Baseline RMDQ score - RMDQ Score at 2-day (48 hour) follow-up' with positive scores being indicative of improvement (less pain disability).
Measured: Baseline to 48 hours
Secondary outcomes (13)
Worst Low Back Pain (LBP)
Worst low back was evaluated by asking patients "How would you describe your worst low back pain in the last 24 hours?" Patients were asked to describe their worst LBP using the terms "Severe", "Moderate", "Mild", or "None". Counts of participants reporting each degree of severity over the prior 24 hours are summarized.
Measured: 48 hours
Use of Medication for Low Back Pain (LBP)
Participants were asked "During the last 24 hours, have you taken any medication at all for low back pain?" and asked to respond either "Yes" or "No". Counts of participants using medication during the prior 24 hours are summarized.
Measured: 48 hours
Frequency of Low Back Pain (LBP)
Frequency of Low Back Pain will be evaluated by asking patients "Over the last 24 hours, how often were you in pain?" Patients will be asked to respond to the frequency of their LBP over the prior 24 hours based on a 5-point Likert scale consisting of "Not at all", "Rarely", "Sometimes", "Usually", or "Always". This question will help determine the burdensomeness of the LBP in the patient's daily life. Counts of participants reporting each frequency will be summarized.
Measured: 48 hours
Return to Usual Activities
The percentage of patients who were able to return to usual activities following treatment will be quantified by asking patients to provide a binary "Yes" or "No" response to a question of whether they were able to return to day-to-day activities. Results will be summarized by treatment group.
Measured: 48 hours
Number of Visits to Any Healthcare Provider
The number of visits to any healthcare provider will be determined by asking patients whether they had any planned or emergent inpatient or outpatient visits to any healthcare provider for any reason during the course of the study. Group mean results will be summarized by treatment group.
Measured: 48 hours
Treatment Satisfaction
Patient satisfaction with the treatment they received will be assessed by their response to a binary "Yes" or "No" question regarding satisfaction with their treatment. Results will be summarized by treatment group.
Measured: 48 hours
Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score
Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Change in RMDQ was measured by calculating: 'Baseline RMDQ score - RMDQ Score at 7-day follow-up with positive scores being indicative of improvement (less pain disability).
Measured: 7 days
Worst Low Back Pain (LBP)
Worst low back was evaluated by asking patients "How would you describe your worst low back pain in the last 24 hours?" Patients were asked to describe their worst LBP using the terms "Severe", "Moderate", "Mild", or "None". Counts of participants reporting each degree of severity over the prior 24 hours are summarized.
Measured: 7 days
Use of Medication for Low Back Pain (LBP)
Participants were asked "During the last 24 hours, have you taken any medication at all for low back pain?" and asked to respond either "Yes" or "No". Counts of participants using medication during the prior 24 hours are summarized.
Measured: 7 days
Frequency of Low Back Pain
Frequency of Low Back Pain will be evaluated by asking patients "Over the last 24 hours, how often were you in pain?" Patients will be asked to respond to the frequency of their LBP over the prior 24 hours based on a 5-point Likert scale consisting of "Not at all", "Rarely", "Sometimes", "Usually", or "Always". This question will help determine the burdensomeness of the LBP in the patient's daily life. Counts of participants reporting each frequency will be summarized.
Measured: 7 days
Return to Usual Activities
The percentage of patients who were able to return to usual activities following treatment will be quantified by asking patients to provide a binary "Yes" or "No" response to a question of whether they were able to return to day-to-day activities. Results will be summarized by treatment group.
Measured: 7 days
Number of Visits to Any Healthcare Provider
The number of visits to any healthcare provider will be determined by asking patients whether they had any planned or emergent inpatient or outpatient visits to any healthcare provider for any reason during the course of the study. Group mean results will be summarized by treatment group.
Measured: 7 days
Treatment Satisfaction
Patient satisfaction with the treatment they received will be assessed by their response to a binary "Yes" or "No" question regarding satisfaction with their treatment. Results will be summarized by treatment group.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start2 Mar 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- 198 participants (actual)
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
- NCT04611529
- Sponsor's protocol ID
- 2020-12418
- Status last verified
- May 2026
- First submitted
- 28 Oct 2020
- Last updated
- 11 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khankhel N, Friedman BW, Baer J, Lopez L, Feliciano C, Lee S, Irizarry E. Topical Diclofenac Versus Oral Ibuprofen Versus Diclofenac + Ibuprofen for Emergency Department Patients With Acute Low Back Pain: A Randomized Study. Ann Emerg Med. 2024 Jun;83(6):542-551. doi: 10.1016/j.annemergmed.2024.01.037. Epub 2024 Mar 2.
PubMed 38441515
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Topical Diclofenac Versus Oral Ibuprofen for Acute Non-radicular Low Back Pain
- ClinicalTrials.gov ID
- NCT04611529
- Acronym / sponsor ID
- 2020-12418
- Conditions
- Low Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind placebo-controlled study comparing two different treatments for acute low back pain: oral ibuprofen and topical diclofenac. Participants will be randomized to one of three study arms: 1) Oral ibuprofen + topical diclofenac; 2) Oral ibuprofen + topical placebo; 3) Oral placebo + topical diclofenac. Outcomes will be determined at 48 hours (2 days) and 7 days later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral ibuprofen + topical diclofenac | Experimental | Drug: Ibuprofen 400 mg, Drug: Topical diclofenacOral ibuprofen 400mg Topical diclofenac 4gm |
| Oral ibuprofen + topical placebo | Active comparator | Drug: Ibuprofen 400 mgOral ibuprofen 400mg Topical placebo |
| Oral placebo + topical diclofenac | Active comparator | Drug: Topical diclofenacOral placebo Topical diclofenac 4gm |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Present to Emergency Department (ED) primary for management of Low Back Pain (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.
- Age 18-69. Enrollment will be limited to adults younger than 70 years because of the increased risk of adverse medication effects in the elderly.
- Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
Key exclusion criteria (6 listed)
- Not available for follow-up
- Pregnant
- Any analgesic medication use on a daily or near-daily basis
- Allergic to or intolerant of investigational medications
- Open wounds or skin breakdown of the lower back
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 |
|---|---|---|
| Ibuprofen 400 mgIbuprofen 400mg | Drug | Oral ibuprofen + topical diclofenac, Oral ibuprofen + topical placebo |
| Topical diclofenacDiclofenac 1% gel 4gm | Drug | Oral ibuprofen + topical diclofenac, Oral placebo + topical diclofenac |
Primary outcome
Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score
Time frame: Baseline to 48 hours
Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report 'Yes/no' instrument about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Change in RMDQ was measured by calculating: 'Baseline RMDQ score - RMDQ Score at 2-day (48 hour) follow-up' with positive scores being indicative of improvement (less pain disability).
13 secondary outcomes
Worst Low Back Pain (LBP)
Time frame: 48 hours
Use of Medication for Low Back Pain (LBP)
Time frame: 48 hours
Frequency of Low Back Pain (LBP)
Time frame: 48 hours
Return to Usual Activities
Time frame: 48 hours
Number of Visits to Any Healthcare Provider
Time frame: 48 hours
Treatment Satisfaction
Time frame: 48 hours
Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score
Time frame: 7 days
Worst Low Back Pain (LBP)
Time frame: 7 days
Use of Medication for Low Back Pain (LBP)
Time frame: 7 days
Frequency of Low Back Pain
Time frame: 7 days
Return to Usual Activities
Time frame: 7 days
Number of Visits to Any Healthcare Provider
Time frame: 7 days
Treatment Satisfaction
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38441515Khankhel N, Friedman BW, Baer J, Lopez L, Feliciano C, Lee S, Irizarry E. Topical Diclofenac Versus Oral Ibuprofen Versus Diclofenac + Ibuprofen for Emergency Department Patients With Acute Low Back Pain: A Randomized Study. Ann Emerg Med. 2024 Jun;83(6):542-551. doi: 10.1016/j.annemergmed.2024.01.037. Epub 2024 Mar 2.
- 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. This study is not recruiting at the moment.
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 Ibuprofen 400 mg and Topical diclofenac in people with Low Back Pain, 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 9 inclusion and 6 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: finished, as of the sponsor's last update on 11 Jun 2026. 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. 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?
Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score (time frame: Baseline to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04611529, which also lists 1 linked publication.
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 11 Jun 2026.