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

Primary Purpose

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

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen 400 mg
Dexamethasone Oral
Educational Intervention
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiculopathy, Lumbosacral Region focused on measuring ibuprofen, dexamethasone, radiculopathy, low back pain, back pain with radiation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Albert Einstein College of Medicine/Montefiore Medical Center - Weiler EDRecruiting
  • Montefiore Medical Center - Moses EDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ibuprofen + dexamethasone + educational intervention

Ibuprofen + placebo + educational intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
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
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
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
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
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

Full Information

First Posted
January 31, 2023
Last Updated
August 18, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05721027
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy, Lumbosacral Region, Back Pain With Radiation, Low Back Pain
Keywords
ibuprofen, dexamethasone, radiculopathy, low back pain, back pain with radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ibuprofen + dexamethasone + educational intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Ibuprofen + placebo + educational intervention
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 400 mg
Intervention Description
Ibuprofen 400 mg PO every 8 hours as needed for 7 days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Oral
Intervention Description
Dexamethasone 16 mg PO during ED visit and next day
Intervention Type
Behavioral
Intervention Name(s)
Educational Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Roland Morris Disability Questionnaire (RMDQ) score
Description
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)
Time Frame
2 days (48 hours)
Secondary Outcome Measure Information:
Title
Worst Radicular LBP
Description
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
Time Frame
2 days and 7 days after ED discharge
Title
Frequency of Radicular LBP
Description
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
Time Frame
2 days and 7 days after ED discharge
Title
Analgesic or LBP medication within the previous 24 hours
Description
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
Time Frame
2 days and 7 days after ED discharge
Title
Absolute Roland Morris Disability Questionnaire (RMDQ) score
Description
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
Time Frame
2 days and 7 days after ED discharge
Title
Return to all usual activities
Description
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
Time Frame
2 days and 7 days after ED discharge
Title
Number of visits to any healthcare provider
Description
The number of aggregate visits to any healthcare provider will be tabulated at 2 days and 7 days after ED discharge
Time Frame
2 days and 7 days after ED discharge
Title
Satisfaction with Treatment
Description
Satisfaction with treatment will be evaluated based on a binary (Yes/No) response at 2 days and 7 days after ED discharge
Time Frame
2 days and 7 days after ED discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eddie Irizarry, MD
Phone
718-920-6626
Email
eddiriza@montefiore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eddie Irizarry, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center - Moses ED
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eddie Irizarry, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share
Links:
URL
https://www.niams.nih.gov/health-topics/back-pain
Description
National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information

Learn more about this trial

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

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