Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.

Low Back Pain Clinical Trial

Official title:

Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05721027
• Other study ID #: 2023-14723
• Status: Recruiting
• Phase: Phase 4
• Start date: July 5, 2023
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: Montefiore Medical Center
• Contact: Eddie Irizarry, MD
• Phone: 718-920-6626
• Email: eddiriza[@]montefiore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: August 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Back Pain With Radiation
• Low Back Pain
• Radiculopathy
• Radiculopathy, Lumbosacral Region

Intervention

Drug:
• Ibuprofen 400 mg
Ibuprofen 400 mg PO every 8 hours as needed for 7 days
• Dexamethasone Oral
Dexamethasone 16 mg PO during ED visit and next day

Behavioral:
• Educational Intervention
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

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED	Bronx	New York
United States	Montefiore Medical Center - Moses ED	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	2 days and 7 days after ED discharge
Secondary	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	2 days and 7 days after ED discharge
Secondary	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	2 days and 7 days after ED discharge
Secondary	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	2 days and 7 days after ED discharge
Secondary	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	2 days and 7 days after ED discharge
Secondary	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	2 days and 7 days after ED discharge
Secondary	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	2 days and 7 days after ED discharge

External Links

•   National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information