Back Pain With Radiation, Low Back Pain, Radiculopathy, Lumbosacral Region
Conditions
Keywords
ibuprofen, dexamethasone, radiculopathy, low back pain, back pain with radiation
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.
Interventions
BEHAVIORALEducational 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
DRUGIbuprofen 400 mg
Ibuprofen 400 mg PO every 8 hours as needed for 7 days
DRUGDexamethasone Oral
Dexamethasone 16 mg PO during ED visit and next day
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTEddie Irizarry, MD
PRINCIPAL_INVESTIGATOREddie Irizarry, MD
Montefiore Medical Center
Outcome results
None listed