A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.

NCT03861611 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2019-10026
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: This is a randomized clinical trial comparing the effects of three different medications for acute low back pain (LBP):Ketorolac, Ibuprofen, Diclofenac 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)

Conditions

Back Pain Without Radiation; Low Back Pain

Keywords

ketorolac; diclofenac; ibuprofen; low back pain; back pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Day 5 in Functional Impairment

  The change will be assessed by Roland Morris Disability Questionnaire between the baseline ED visit and the five day follow-up. The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale (0-24).

  Baseline to 5 days

Secondary Outcomes (3)

• Worst LBP 2 Days After ED Visit

  2 days after Emergency department visit

• Frequency of LBP 2 Days After ED Visit

  2 days after Emergency department visit

• How Often Participants Used Assigned Medication

  24 hours to 5 days

Study Arms (3)

Ketorolac + Educational Intervention

EXPERIMENTAL

Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.

Drug: Ketorolac; Behavioral: Educational Intervention

Ibuprofen + Educational Intervention

EXPERIMENTAL

Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.

Drug: Ibuprofen; Behavioral: Educational Intervention

Diclofenac + Educational Intervention

EXPERIMENTAL

Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.

Drug: Diclofenac; Behavioral: Educational Intervention

Interventions

Ketorolac DRUG

Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed

Ketorolac + Educational Intervention

Ibuprofen DRUG

Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed

Ibuprofen + Educational Intervention

Diclofenac DRUG

Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed

Diclofenac + Educational Intervention

Educational Intervention BEHAVIORAL

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; Ibuprofen + Educational Intervention; Ketorolac + Educational Intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women age 18-64.
• 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.

You may not qualify if:

• Flank pain, that is pain originating from tissues lateral to the paraspinal muscles.
• Not available for follow-up
• Pregnant
• Chronic pain syndrome
• Allergic to or intolerant of investigational medications
• Contra-indications to investigational medications

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Links

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

MeSH Terms

Conditions

Back Pain; Low Back Pain

Interventions

Ketorolac; Ibuprofen; Diclofenac; Early Intervention, Educational

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Phenylacetates; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Results Point of Contact

• Title: Eddie Irizarry, MD
• Organization: Montefiore Medical Center

eddiriza@montefiore.org

718-904-2104

Study Officials

• Eddie Irizarry, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 4, 2019
• Study Start: July 12, 2019
• Primary Completion: February 2, 2021
• Study Completion: February 2, 2021
• Last Updated: May 31, 2022
• Results First Posted: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)