Back Pain Without RadiationPhase 4NCT03861611
A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.
A Phase 4 study testing Ketorolac, Ibuprofen and Diclofenac in people with Back Pain Without Radiation and Low Back Pain, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Purpose: This is a randomized clinical trial comparing the effects of three different medications for acute low back pain (LBP):Ketorolac, Ibuprofen, Diclofenac Hypothesis: A daily regimen of ketorolac will provide greater relief of LBP than ibuprofen or diclofenac 5 days after an emergency department (ED) visit, as… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Back Pain Without Radiation, Low Back Pain
- What is being tested?
- Ketorolac, Ibuprofen and Diclofenac
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2019to 2 Feb 2021
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men or women age 18-64.
- Present to ED primary for management of Low Back Pain (LBP)
- Functionally impairing back pain: A baseline score of greater than 5 on the Roland-Morris Disability Questionnaire
- Musculoskeletal etiology of low back.
- Non-radicular pain.
- Pain duration <2 weeks (336 hours).
- Non-traumatic LBP
- Participant is to be discharged home.
Who cannot join
- Flank pain, that is pain originating from tissues lateral to the paraspinal muscles.
- Not available for follow-up
- Pregnant
- Chronic pain syndrome
- Allergic to or intolerant of investigational medications
- Contra-indications to investigational medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain. A Randomized Trial
Purpose: This is a randomized clinical trial comparing the effects of three different medications for acute low back pain (LBP):Ketorolac, Ibuprofen, Diclofenac
Hypothesis: A daily regimen of ketorolac will provide greater relief of LBP than ibuprofen or diclofenac 5 days after an emergency department (ED) visit, as measured by the Roland Morris Disability Questionnaire (RMQ)
Read the detailed description
More than 2.5 million patients present to US emergency departments (ED) annually with low back pain. Up to half of ED patients with acute, new onset low back pain (LBP) report persistent moderate or severe pain one week after the ED visit. Non-steroidal anti-inflammatory drugs (NSAIDs) are an effective treatment of acute LBP, though their impact is only modest.Given the poor pain and functional outcomes that persist beyond an ED visit for acute LBP, this clinical trial proposes to determine whether there is a difference in efficacy between the NSAIDs ketorolac, ibuprofen, and diclofenac and for the treatment of acute, non-traumatic, non-radicular low back pain.
- Conditions
- Back Pain Without Radiation, Low Back Pain
- Keywords
- ketorolac, diclofenac, ibuprofen, low back pain, back pain
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed
IbuprofenDrug
Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
DiclofenacDrug
Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed
Educational InterventionBehavioural
Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac + Educational Intervention | Experimental | Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention. Receives: Drug: Ketorolac; Behavioral: Educational Intervention |
| Ibuprofen + Educational Intervention | Experimental | Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention. Receives: Drug: Ibuprofen; Behavioral: Educational Intervention |
| Diclofenac + Educational Intervention | Experimental | Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention. Receives: Drug: Diclofenac; Behavioral: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Day 5 in Functional Impairment
The change will be assessed by Roland Morris Disability Questionnaire between the baseline ED visit and the five day follow-up. The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale (0-24).
Measured: Baseline to 5 days
Secondary outcomes (3)
Worst LBP 2 Days After ED Visit
Participants were called 2 days after ED visit and asked to report their worst LBP experienced over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none.
Measured: 2 days after Emergency department visit
Frequency of LBP 2 Days After ED Visit
Participants were called 2 days after ED visit and asked to report the frequency of LBP experienced over the previous 24 hours. Frequency was assessed using the five point Likert scale: Not at all, Rarely, Sometimes, Usually, Always
Measured: 2 days after Emergency department visit
How Often Participants Used Assigned Medication
Measured: 24 hours to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start12 Jul 2019
- Primary completion2 Feb 2021
- Study completion2 Feb 2021
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.
- Other trials for Back Pain Without RadiationStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eddie Irizarry, Montefiore Medical Center
- Investigators
- Eddie Irizarry, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861611
- Sponsor's protocol ID
- 2019-10026
- Other IDs
- 2019
- Status last verified
- May 2022
- First submitted
- 1 Mar 2019
- Last updated
- 31 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain. A Randomized Trial
- ClinicalTrials.gov ID
- NCT03861611
- Acronym / sponsor ID
- 2019-10026
- Conditions
- Back Pain Without Radiation, Low Back Pain
- Keywords
- ketorolac, diclofenac, ibuprofen, low back pain, 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
- 12 Jul 2019 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Posted 31 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: This is a randomized clinical trial comparing the effects of three different medications for acute low back pain (LBP):Ketorolac, Ibuprofen, Diclofenac
Hypothesis: A daily regimen of ketorolac will provide greater relief of LBP than ibuprofen or diclofenac 5 days after an emergency department (ED) visit, as measured by the Roland Morris Disability Questionnaire (RMQ)
Detailed description
More than 2.5 million patients present to US emergency departments (ED) annually with low back pain. Up to half of ED patients with acute, new onset low back pain (LBP) report persistent moderate or severe pain one week after the ED visit. Non-steroidal anti-inflammatory drugs (NSAIDs) are an effective treatment of acute LBP, though their impact is only modest.Given the poor pain and functional outcomes that persist beyond an ED visit for acute LBP, this clinical trial proposes to determine whether there is a difference in efficacy between the NSAIDs ketorolac, ibuprofen, and diclofenac and for the treatment of acute, non-traumatic, non-radicular low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketorolac + Educational Intervention | Experimental | Drug: Ketorolac, Behavioral: Educational InterventionParticipants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention. |
| Ibuprofen + Educational Intervention | Experimental | Drug: Ibuprofen, Behavioral: Educational InterventionParticipants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention. |
| Diclofenac + Educational Intervention | Experimental | Drug: Diclofenac, Behavioral: Educational InterventionParticipants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men or women age 18-64.
- Present to ED primary for management of Low Back Pain (LBP)
- Functionally impairing back pain: A baseline score of greater than 5 on the Roland-Morris Disability Questionnaire
- Musculoskeletal etiology of low back.
- Non-radicular pain.
Key exclusion criteria (6 listed)
- Flank pain, that is pain originating from tissues lateral to the paraspinal muscles.
- Not available for follow-up
- Pregnant
- Chronic pain syndrome
- Allergic to or intolerant of investigational medications
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 |
|---|---|---|
| KetorolacParticipants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed | Drug | Ketorolac + Educational Intervention |
| IbuprofenParticipants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed | Drug | Ibuprofen + Educational Intervention |
| DiclofenacParticipants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed | Drug | Diclofenac + Educational Intervention |
| Educational InterventionResearch personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information | Behavioural | Diclofenac + Educational Intervention, Ibuprofen + Educational Intervention, Ketorolac + Educational Intervention |
Primary outcome
Change From Baseline to Day 5 in Functional Impairment
Time frame: Baseline to 5 days
The change will be assessed by Roland Morris Disability Questionnaire between the baseline ED visit and the five day follow-up. The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale (0-24).
3 secondary outcomes
Worst LBP 2 Days After ED Visit
Time frame: 2 days after Emergency department visit
Frequency of LBP 2 Days After ED Visit
Time frame: 2 days after Emergency department visit
How Often Participants Used Assigned Medication
Time frame: 24 hours to 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain informationLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to share
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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.
Eddie Irizarry, 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 Ketorolac, Ibuprofen and Diclofenac in people with Back Pain Without Radiation and 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 8 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 31 May 2022. 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 31 May 2022). 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 From Baseline to Day 5 in Functional Impairment (time frame: Baseline to 5 days). 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 31 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.