NCT05721027

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for phase_4

Timeline
17mo left

Started Jul 2023

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jul 2023Oct 2027

First Submitted

Initial submission to the registry

January 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 5, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4.2 years

First QC Date

January 31, 2023

Last Update Submit

April 7, 2026

Conditions

Radiculopathy, Lumbosacral RegionBack Pain With RadiationLow Back Pain

Keywords

ibuprofendexamethasoneradiculopathylow back painback pain with radiation

Outcome Measures

Primary Outcomes (1)

  • 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)

    2 days (48 hours)

Secondary Outcomes (7)

  • Worst Radicular LBP

    2 days and 7 days after ED discharge

  • Frequency of Radicular LBP

    2 days and 7 days after ED discharge

  • Analgesic or LBP medication within the previous 24 hours

    2 days and 7 days after ED discharge

  • Absolute Roland Morris Disability Questionnaire (RMDQ) score

    2 days and 7 days after ED discharge

  • Return to all usual activities

    2 days and 7 days after ED discharge

  • +2 more secondary outcomes

Study Arms (2)

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.

Drug: Ibuprofen 400 mgDrug: Dexamethasone OralBehavioral: 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.

Drug: Ibuprofen 400 mgBehavioral: Educational Intervention

Interventions

Ibuprofen 400 mgDRUG

Ibuprofen 400 mg PO every 8 hours as needed for 7 days

Ibuprofen + dexamethasone + educational interventionIbuprofen + placebo + educational intervention
Dexamethasone OralDRUG

Dexamethasone 16 mg PO during ED visit and next day

Ibuprofen + dexamethasone + educational intervention
Educational InterventionBEHAVIORAL

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

Ibuprofen + dexamethasone + educational interventionIbuprofen + placebo + educational intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED

The Bronx, New York, 10461, United States

RECRUITING

Montefiore Medical Center - Moses ED

The Bronx, New York, 10467, United States

RECRUITING

Related Links

MeSH Terms

Conditions

RadiculopathyBack PainLow Back Pain

Interventions

IbuprofenDexamethasoneEarly Intervention, Educational

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChild Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Eddie Irizarry, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eddie Irizarry, MD

CONTACT

718-920-6626eddiriza@montefiore.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 9, 2023

Study Start

July 5, 2023

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

No plan to share

Locations

US(2)