A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.
NCT ID: NCT03861611
Last Updated: 2022-05-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
198 participants
INTERVENTIONAL
2019-07-12
2021-02-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Hypothesis: A daily regimen of ketorolac will provide greater relief of LBP than ibuprofen or diclofenac 5 days after an emergency department (ED) visit, as measured by the Roland Morris Disability Questionnaire (RMQ)
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomized Trial of NSAID Dosing Strategies
NCT05239767
Ibuprofen With or Without Acetaminophen for Low Back Pain
NCT03554018
Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.
NCT04611529
Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
NCT05721027
Ibuprofen Versus Ketorolac for Pain Relief During Hysterosalpingogram
NCT05190341
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ketorolac + Educational Intervention
Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ketorolac
Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed
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
Ibuprofen + Educational Intervention
Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ibuprofen
Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
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
Diclofenac + Educational Intervention
Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Diclofenac
Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ketorolac
Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed
Ibuprofen
Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
Diclofenac
Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Present to ED primary for management of Low Back Pain (LBP)
* Functionally impairing back pain: A baseline score of greater than 5 on the Roland-Morris Disability Questionnaire
* Musculoskeletal etiology of low back.
* Non-radicular pain.
* Pain duration \<2 weeks (336 hours).
* Non-traumatic LBP
* Participant is to be discharged home.
Exclusion Criteria
* Not available for follow-up
* Pregnant
* Chronic pain syndrome
* Allergic to or intolerant of investigational medications
* Contra-indications to investigational medications
18 Years
64 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Montefiore Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eddie Irizarry
Assistant Professor of Emergency Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eddie Irizarry, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Montefiore Medical Center
The Bronx, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-10026
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.