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This is a randomized clinical trial comparing two interventions for acute low back pain:
Participants will include patients who present to an emergency room for management of low back pain. Medication will be dispensed to participants at the time of emergency room discharge. Data will be collected from participants by telephone for 1 week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen | Experimental | Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. |
|
| Placebo | Active Comparator | Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Acetaminophen 500-1000mg every 6 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire | The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians. | Baseline and one week after discharge from emergency department |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale | Data collected by telephone questionnaire. Participants asked to assess intensity of low back pain over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none. | 7 days after discharge from emergency department |
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Inclusion Criteria:
Present to emergency room primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin W Friedman, MD, MS | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen and Acetaminophen | Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Acetaminophen: Acetaminophen 500-1000mg every 6 hours Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (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) |
| FG001 | Ibuprofen and Placebo | Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (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) Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen and Acetaminophen | Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Acetaminophen: Acetaminophen 500-1000mg every 6 hours Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (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 in Functional Impairment as Measured by the Roland Morris Disability Questionnaire | The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians. | Posted | Mean | Standard Deviation | units on a scale | Baseline and one week after discharge from emergency department |
|
48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibuprofen and Acetaminophen | Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Acetaminophen: Acetaminophen 500-1000mg every 6 hours Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Friedman | Montefiore | 718-920-6626 | befriedm@montefiore.org |
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| 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 | Jul 19, 2018 | Jul 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Ibuprofen 600 mg |
| Drug |
Ibuprofen 600mg every 6 hours |
|
| Educational intervention | Behavioral | Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (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) |
|
| Placebo oral capsule | Drug | To match acetaminophen, patients will take one or two capsules every 6 hours |
|
| Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours. |
Telephone questionnaire is used to assess number of patients needing any analgesic or low back pain medication within the previous 24 hours. |
| 7 days after discharge from emergency department |
| BG001 | Ibuprofen and Placebo | Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (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) Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours |
| BG002 | 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 |
|
| Region of Enrollment | Number | participants |
|
| Duration of low back pain | Median | Inter-Quartile Range | hours |
|
| OG001 | Ibuprofen and Placebo | Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (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) Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours |
|
|
| Secondary | Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale | Data collected by telephone questionnaire. Participants asked to assess intensity of low back pain over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none. | Posted | Count of Participants | Participants | 7 days after discharge from emergency department |
|
|
|
| Secondary | Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours. | Telephone questionnaire is used to assess number of patients needing any analgesic or low back pain medication within the previous 24 hours. | Data was collected and analyzed for 52 participants in the "Ibuprofen and Placebo" group. | Posted | Count of Participants | Participants | 7 days after discharge from emergency department |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 5 |
| 60 |
| EG001 | Ibuprofen and Placebo | Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (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) Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours | 0 | 60 | 0 | 60 | 2 | 60 |
| Drowsiness | Nervous system disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |