Radiculopathy, Lumbosacral RegionPhase 4NCT05721027
Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
A Phase 4 study testing Ibuprofen 400 mg, Dexamethasone Oral and Educational Intervention in people with Radiculopathy, Lumbosacral Region and Back Pain With Radiation, run by Montefiore Medical Center at 2 sites in United States.
Trial summary
This will be a placebo controlled, randomized, double-blind, comparative effectiveness study, in which we patients are enrolled during an emergency department (ED) visit for acute radicular low back pain (LBP) and followed by telephone two and seven days later. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiculopathy, Lumbosacral Region, Back Pain With Radiation, Low Back Pain
- What is being tested?
- Ibuprofen 400 mg, Dexamethasone Oral and Educational Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jul 2023to Oct 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Present to ED primarily for management of acute radicular LBP, defined as pain or paresthesia originating from the lower back and radiating to the buttock and or leg in a radicular pattern. Some patients may not have prominent LBP but a radicular symptom--we will include these patients as well.
- Patient is to be discharged home.
- Age 18-70 Enrollment will be limited to adults <70 years because of the increased risk of adverse medication effects in older adults.
- Pain duration <2 week
- Prior to the acute attack of radicular LBP, back pain cannot occur more frequently than half of the days in the last 3 months. Patients with more frequent back pain/sciatica are at increased risk of poor pain and functional outcomes.10
- Non-traumatic cause of pain: no substantial and direct trauma to the back within the previous month
- Functionally impairing radicular LBP: A baseline score of > 5 on the Roland-Morris Disability Questionnaire
Who cannot join
- Not available for follow-up
- Pregnant
- Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis
- Allergic to or intolerant of investigational medications
- Chronic steroid use
- 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED
The Bronx, New York, 10461
- Recruiting
Montefiore Medical Center - Moses ED
The Bronx, New York, 10467
Eddie Irizarry, MD
About this study
This will be a placebo controlled, randomized, double-blind, comparative effectiveness study, in which we patients are enrolled during an emergency department (ED) visit for acute radicular low back pain (LBP) and followed by telephone two and seven days later. Patients will be randomized to receive an oral dose of dexamethasone for 2 consecutive days or placebo during an ED visit for acute radicular LBP. Every patient will receive a 7 day supply of ibuprofen and a low back pain education session.
- Being tested
- Ibuprofen 400 mg, Dexamethasone Oral, Educational Intervention
- Keywords
- ibuprofen, dexamethasone, radiculopathy, low back pain, back pain with radiation
- Medical subject headings
- Radiculopathy, Back Pain, 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 400 mg PO every 8 hours as needed for 7 days
Dexamethasone OralDrug
Dexamethasone 16 mg PO during ED visit and next day
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 |
|---|---|---|
| Ibuprofen + dexamethasone + educational intervention | Experimental | Ibuprofen 400 mg PO every 8 hours as needed for 7 days + dexamethasone 16 mg PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention. Receives: Drug: Ibuprofen 400 mg; Drug: Dexamethasone Oral; Behavioral: Educational Intervention |
| Ibuprofen + placebo + educational intervention | Placebo comparator | Ibuprofen 400 mg PO every 8 hours as needed for 7 days + placebo PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention. Receives: Drug: Ibuprofen 400 mg; Behavioral: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Roland Morris Disability Questionnaire (RMDQ) score
The change in RMDQ will be evaluated using the 24-item Roland Morris Low Back Pain Disability Questionnaire. The RMDQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMDQ score ranging from 0 to 24. Higher scores represent higher levels of pain-related disability. The change will be calculated as a difference between the baseline ED visit and the two day follow-up visit (Roland-Morris baseline - Roland-Morris day 2)
Measured: 2 days (48 hours)
Secondary outcomes (7)
Worst Radicular LBP
Worst Radicular LBP pain incurred over the previous 24 hours will be assessed at 2 days and 7 days after ED discharge using a four point ordinal scale: Severe, Moderate, Mild, or None
Measured: 2 days and 7 days after ED discharge
Frequency of Radicular LBP
Frequency of Radicular LBP is evaluated at 2 days and 7 days after ED discharge based on a five point Likert scale: Not at all, Rarely, Sometimes, Usually, and Always
Measured: 2 days and 7 days after ED discharge
Analgesic or LBP medication within the previous 24 hours
Administration of any analgesic or LBP medication (Yes or No) within the previous 24 hours will be assessed at 2 days and 7 days after ED discharge
Measured: 2 days and 7 days after ED discharge
Absolute Roland Morris Disability Questionnaire (RMDQ) score
The Absolute RMDQ score will be tabulated at 2 days and 7 days after ED discharge. The RMDQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMDQ score ranging from 0 to 24. Higher scores represent higher levels of pain-related disability
Measured: 2 days and 7 days after ED discharge
Return to all usual activities
The patient will be evaluated for the ability to return to all usual activities at 2 days and 7 days after ED discharge based on a binary (Yes/No) response
Measured: 2 days and 7 days after ED discharge
Number of visits to any healthcare provider
The number of aggregate visits to any healthcare provider will be tabulated at 2 days and 7 days after ED discharge
Measured: 2 days and 7 days after ED discharge
Satisfaction with Treatment
Satisfaction with treatment will be evaluated based on a binary (Yes/No) response at 2 days and 7 days after ED discharge
Measured: 2 days and 7 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 posted9 Feb 2023
- Study start5 Jul 2023
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiculopathy, Lumbosacral RegionStudies 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
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eddie Irizarry, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721027
- Sponsor's protocol ID
- 2023-14723
- Other IDs
- 2023
- Status last verified
- Apr 2026
- First submitted
- 31 Jan 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
- ClinicalTrials.gov ID
- NCT05721027
- Acronym / sponsor ID
- 2023-14723
- Keywords
- ibuprofen, dexamethasone, radiculopathy, low back pain, back pain with radiation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 9 Feb 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 will be a placebo controlled, randomized, double-blind, comparative effectiveness study, in which we patients are enrolled during an emergency department (ED) visit for acute radicular low back pain (LBP) and followed by telephone two and seven days later. Patients will be randomized to receive an oral dose of dexamethasone for 2 consecutive days or placebo during an ED visit for acute radicular LBP. Every patient will receive a 7 day supply of ibuprofen and a low back pain education session.
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 |
|---|---|---|
| Ibuprofen + dexamethasone + educational intervention | Experimental | Drug: Ibuprofen 400 mg, Drug: Dexamethasone Oral, Behavioral: Educational InterventionIbuprofen 400 mg PO every 8 hours as needed for 7 days + dexamethasone 16 mg PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention. |
| Ibuprofen + placebo + educational intervention | Placebo comparator | Drug: Ibuprofen 400 mg, Behavioral: Educational InterventionIbuprofen 400 mg PO every 8 hours as needed for 7 days + placebo PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Present to ED primarily for management of acute radicular LBP, defined as pain or paresthesia originating from the lower back and radiating to the buttock and or leg in a radicular pattern. Some patients may not have prominent LBP but a radicular symptom--we will include these patients as well.
- Patient is to be discharged home.
- Age 18-70 Enrollment will be limited to adults <70 years because of the increased risk of adverse medication effects in older adults.
- Pain duration <2 week
- Prior to the acute attack of radicular LBP, back pain cannot occur more frequently than half of the days in the last 3 months. Patients with more frequent back pain/sciatica are at increased risk of poor pain and functional outcomes.10
Key exclusion criteria (6 listed)
- Not available for follow-up
- Pregnant
- Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis
- Allergic to or intolerant of investigational medications
- Chronic steroid use
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 400 mg PO every 8 hours as needed for 7 days | Drug | Ibuprofen + dexamethasone + educational intervention, Ibuprofen + placebo + educational intervention |
| Dexamethasone OralDexamethasone 16 mg PO during ED visit and next day | Drug | Ibuprofen + dexamethasone + 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 | Ibuprofen + dexamethasone + educational intervention, Ibuprofen + placebo + educational intervention |
Primary outcome
Change in Roland Morris Disability Questionnaire (RMDQ) score
Time frame: 2 days (48 hours)
The change in RMDQ will be evaluated using the 24-item Roland Morris Low Back Pain Disability Questionnaire. The RMDQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMDQ score ranging from 0 to 24. Higher scores represent higher levels of pain-related disability. The change will be calculated as a difference between the baseline ED visit and the two day follow-up visit (Roland-Morris baseline - Roland-Morris day 2)
7 secondary outcomes
Worst Radicular LBP
Time frame: 2 days and 7 days after ED discharge
Frequency of Radicular LBP
Time frame: 2 days and 7 days after ED discharge
Analgesic or LBP medication within the previous 24 hours
Time frame: 2 days and 7 days after ED discharge
Absolute Roland Morris Disability Questionnaire (RMDQ) score
Time frame: 2 days and 7 days after ED discharge
Return to all usual activities
Time frame: 2 days and 7 days after ED discharge
Number of visits to any healthcare provider
Time frame: 2 days and 7 days after ED discharge
Satisfaction with Treatment
Time frame: 2 days and 7 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 13 Apr 2026.
- 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.
Eddie Irizarry, MD principal investigator
Montefiore Medical Center
2 sites 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, Dexamethasone Oral and Educational Intervention in people with Radiculopathy, Lumbosacral Region and Back Pain With Radiation, run by Montefiore Medical Center at 2 sites 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 7 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Eddie Irizarry, MD (718-920-6626, eddiriza@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Roland Morris Disability Questionnaire (RMDQ) score (time frame: 2 days (48 hours)). 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 13 Apr 2026.