Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
More than 2.5 million patients present to US emergency departments (ED) annually with low back pain. Up to half of ED patients with acute, new onset low back pain (LBP) report persistent moderate or severe pain one week after the ED visit. Non-steroidal anti-inflammatory drugs (NSAIDs) are an effective treatment of acute LBP, though their impact is only modest.Given the poor pain and functional outcomes that persist beyond an ED visit for acute LBP, this clinical trial proposes to determine whether there is a difference in efficacy between the NSAIDs ketorolac, ibuprofen, and diclofenac and for the treatment of acute, non-traumatic, non-radicular low back pain.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Worst LBP 2 Days After ED Visit | Participants were called 2 days after ED visit and asked to report their worst LBP experienced over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none. | 2 days after Emergency department visit |
| Frequency of LBP 2 Days After ED Visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eddie Irizarry, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
Not provided
| Label | URL |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information | View source |
Not provided
No plan to share
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 webpage |
| FG001 | 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 webpage |
| FG002 | 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 Diclofenac 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 webpage |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline to 5 days |
|
5 days
Study participants were asked: Did you have any side effects from the medications you've been taking for low back pain? Study participants were also asked: Did the medication irritate your stomach? 1 patient randomized to ibuprofen was admitted to the hospital for angioedema which was may have been due to concomitant angiotensin converting enzyme inhibitor use.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angioedema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | One participant in the ibuprofen arm was admitted to the hospital for angioedema. This participant was taking an angiotensin converting enzyme inhibitor, which was thought to be the more likely cause of this clinical presentation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach irritation | Gastrointestinal disorders | Non-systematic Assessment | Study participants were asked: Did the medication irritate your stomach? |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eddie Irizarry, MD | Montefiore Medical Center | 718-904-2104 | eddiriza@montefiore.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2019 | Apr 5, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D007052 | Ibuprofen |
| D004008 | Diclofenac |
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ibuprofen | Drug | Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed |
|
| Diclofenac | Drug | Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed |
|
| 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 |
|
Participants were called 2 days after ED visit and asked to report the frequency of LBP experienced over the previous 24 hours. Frequency was assessed using the five point Likert scale: Not at all, Rarely, Sometimes, Usually, Always |
| 2 days after Emergency department visit |
| How Often Participants Used Assigned Medication | 24 hours to 5 days |
| BG001 | 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 webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) |
| BG002 | 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 Diclofenac 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 webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | 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 webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) |
| OG002 | 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 Diclofenac 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 webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) |
|
|
| Secondary | Worst LBP 2 Days After ED Visit | Participants were called 2 days after ED visit and asked to report their worst LBP experienced over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none. | Participants with missing data not reported. | Posted | Count of Participants | Participants | 2 days after Emergency department visit |
|
|
|
| Secondary | Frequency of LBP 2 Days After ED Visit | Participants were called 2 days after ED visit and asked to report the frequency of LBP experienced over the previous 24 hours. Frequency was assessed using the five point Likert scale: Not at all, Rarely, Sometimes, Usually, Always | Participants with missing data not reported. | Posted | Count of Participants | Participants | 2 days after Emergency department visit |
|
|
|
| Secondary | How Often Participants Used Assigned Medication | Participants with missing data not reported. | Posted | Count of Participants | Participants | 24 hours to 5 days |
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| 3 |
| 66 |
| EG001 | 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 webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) | 0 | 66 | 1 | 66 | 16 | 66 |
| EG002 | 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 Diclofenac 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 webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) | 0 | 66 | 0 | 66 | 6 | 66 |
|
|
Not provided
Not provided
Not provided
| D006571 | Heterocyclic Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| Male |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Sometimes |
|
| Frequently |
|
| Always |
|
| Title | Measurements |
|---|---|
|
| Sometimes |
|
| Once a day |
|
| Twice or more a day |
|