Clinical trial NCT05721027: Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
Official title: Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Radiculopathy, Lumbosacral Region
Back Pain With Radiation
Low Back Pain
Keywords: ibuprofen
dexamethasone
radiculopathy
low back pain
back pain with radiation
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in Roland Morris Disability Questionnaire (RMDQ) score
timeFrame: 2 days (48 hours)
Secondary outcomes:
measure: Worst Radicular LBP
timeFrame: 2 days and 7 days after ED discharge
measure: Frequency of Radicular LBP
timeFrame: 2 days and 7 days after ED discharge
measure: Analgesic or LBP medication within the previous 24 hours
timeFrame: 2 days and 7 days after ED discharge
measure: Absolute Roland Morris Disability Questionnaire (RMDQ) score
timeFrame: 2 days and 7 days after ED discharge
measure: Return to all usual activities
timeFrame: 2 days and 7 days after ED discharge
measure: Number of visits to any healthcare provider
timeFrame: 2 days and 7 days after ED discharge
measure: Satisfaction with Treatment
timeFrame: 2 days and 7 days after ED discharge
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses ED
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Eddie Irizarry, MD
role: PRINCIPAL_INVESTIGATOR
References: