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

Sponsor

Montefiore Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05721027

Collaborator

(none)

132

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiculopathy, Lumbosacral Region Back Pain With Radiation Low Back Pain	Drug: Ibuprofen 400 mg Drug: Dexamethasone Oral Behavioral: Educational Intervention	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ibuprofen + dexamethasone + educational intervention 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 mg Ibuprofen 400 mg PO every 8 hours as needed for 7 days Drug: 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
Placebo Comparator: Ibuprofen + placebo + educational intervention 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 mg Ibuprofen 400 mg PO every 8 hours as needed for 7 days 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

Arm

Intervention/Treatment

Experimental: Ibuprofen + dexamethasone + educational intervention

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 mg

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

Drug: 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

Placebo Comparator: Ibuprofen + placebo + educational intervention

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 mg

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

Behavioral: Educational Intervention

Outcome Measures

Primary Outcome Measures

Change in Roland Morris Disability Questionnaire (RMDQ) score [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)

Secondary Outcome Measures

Worst Radicular LBP [2 days and 7 days after ED discharge]
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
Frequency of Radicular LBP [2 days and 7 days after ED discharge]
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
Analgesic or LBP medication within the previous 24 hours [2 days and 7 days after ED discharge]
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
Absolute Roland Morris Disability Questionnaire (RMDQ) score [2 days and 7 days after ED discharge]
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
Return to all usual activities [2 days and 7 days after ED discharge]
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
Number of visits to any healthcare provider [2 days and 7 days after ED discharge]
The number of aggregate visits to any healthcare provider will be tabulated at 2 days and 7 days after ED discharge
Satisfaction with Treatment [2 days and 7 days after ED discharge]
Satisfaction with treatment will be evaluated based on a binary (Yes/No) response at 2 days and 7 days after ED discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)