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This is a randomized study, based in emergency departments, in which the investigators determine the utility of adding various skeletal muscle relaxants to standard therapy, which consists of ibuprofen and an educational session. Patients will be enrolled at the time of an emergency visit and followed for three months to determine outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metaxalone | Active Comparator | Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. |
|
| Tizanidine | Active Comparator | Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. |
|
| Baclofen | Active Comparator | Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. |
|
| Placebo | Placebo Comparator | Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metaxalone | Drug | Metaxalone 400-800mg |
| |
| Tizanidine |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ) | 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. | Baseline and 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience Change in Low Back Pain | Change is assessed by verbal numerical scale of which 0 represents no pain and 10 represents the worst pain imaginable between the baseline ED visit and the one week follow-up (baseline - 1 week ). The baseline questions will refer to the time period immediately prior to ED presentation (Before you came to the ER today, were you able to…..) |
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Inclusion Criteria:
Exclusion Criteria:
per patient
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30955985 | Derived | Friedman BW, Irizarry E, Solorzano C, Zias E, Pearlman S, Wollowitz A, Jones MP, Shah PD, Gallagher EJ. A Randomized, Placebo-Controlled Trial of Ibuprofen Plus Metaxalone, Tizanidine, or Baclofen for Acute Low Back Pain. Ann Emerg Med. 2019 Oct;74(4):512-520. doi: 10.1016/j.annemergmed.2019.02.017. Epub 2019 Apr 5. |
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IPD will not be available
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| ID | Title | Description |
|---|---|---|
| FG000 | Metaxalone | Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Metaxalone: Metaxalone 400-800mg Ibuprofen 600 mg: Ibuprofen Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions. |
| FG001 | Tizanidine | Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Tizanidine: Tizanidine 2-4mg Ibuprofen 600 mg: Ibuprofen Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions. |
| FG002 | Baclofen | Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Baclofen: Baclofen 10-20mg Ibuprofen 600 mg: Ibuprofen Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions. |
| FG003 | Placebo | Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Ibuprofen 600 mg: Ibuprofen Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metaxalone | Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Metaxalone: Metaxalone 400-800mg Ibuprofen 600 mg: Ibuprofen Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions. |
| 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 (RMDQ) | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 7 days |
|
7 days
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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 | Metaxalone | Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Metaxalone: Metaxalone 400-800mg Ibuprofen 600 mg: Ibuprofen Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin W. 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 | Mar 29, 2017 | Nov 7, 2019 | 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 |
|---|---|
| C011301 | metaxalone |
| C023754 | tizanidine |
| D001418 | Baclofen |
| D007052 | Ibuprofen |
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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Medications provided to patients are encapsulated. Medications vials are labelled with investigational stickers.
| Drug |
Tizanidine 2-4mg |
|
| Baclofen | Drug | Baclofen 10-20mg |
|
| Ibuprofen 600 mg | Drug | Ibuprofen |
|
| Educational intervention | Behavioral | Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions. |
|
| Baseline and 7 days |
| Number of Participants With Need for Medication for Low Back Pain | Patients will be asked what medications they have used for low back pain | 7 days |
| Levels of Disability | Disability will be assessed with the Roland-Morris Disability Questionnaire (RMDQ) where patients are asked to tick a box if they agree with 24 statements regarding their ability to perform certain activities (dressing, housework, walking). If the don't agree with the statement (able to perform those activities) they need to leave the tick-box blank or unchecked. Every agreement (tick) counts as a point and an absolute value is formed (min: 0, max: 24). The higher the value the higher the disability level. | 7 days |
| BG001 | Tizanidine | Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Tizanidine: Tizanidine 2-4mg Ibuprofen 600 mg: Ibuprofen Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions. |
| BG002 | Baclofen | Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Baclofen: Baclofen 10-20mg Ibuprofen 600 mg: Ibuprofen Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions. |
| BG003 | Placebo | Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Ibuprofen 600 mg: Ibuprofen Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions. |
| BG004 | 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 in hours | Median | Inter-Quartile Range | hours |
|
| OG001 | Tizanidine | Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Tizanidine: Tizanidine 2-4mg Ibuprofen 600 mg: Ibuprofen Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions. |
| OG002 | Baclofen | Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Baclofen: Baclofen 10-20mg Ibuprofen 600 mg: Ibuprofen Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions. |
| OG003 | Placebo | Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Ibuprofen 600 mg: Ibuprofen Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions. |
|
|
| Secondary | Number of Participants Who Experience Change in Low Back Pain | Change is assessed by verbal numerical scale of which 0 represents no pain and 10 represents the worst pain imaginable between the baseline ED visit and the one week follow-up (baseline - 1 week ). The baseline questions will refer to the time period immediately prior to ED presentation (Before you came to the ER today, were you able to…..) | Posted | Count of Participants | Participants | Baseline and 7 days |
|
|
|
| Secondary | Number of Participants With Need for Medication for Low Back Pain | Patients will be asked what medications they have used for low back pain | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Levels of Disability | Disability will be assessed with the Roland-Morris Disability Questionnaire (RMDQ) where patients are asked to tick a box if they agree with 24 statements regarding their ability to perform certain activities (dressing, housework, walking). If the don't agree with the statement (able to perform those activities) they need to leave the tick-box blank or unchecked. Every agreement (tick) counts as a point and an absolute value is formed (min: 0, max: 24). The higher the value the higher the disability level. | Posted | Median | Inter-Quartile Range | units on a scale | 7 days |
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 6 |
| 80 |
| EG001 | Tizanidine | Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Tizanidine: Tizanidine 2-4mg Ibuprofen 600 mg: Ibuprofen Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions. | 0 | 80 | 0 | 80 | 6 | 80 |
| EG002 | Baclofen | Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Baclofen: Baclofen 10-20mg Ibuprofen 600 mg: Ibuprofen Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions. | 0 | 80 | 0 | 80 | 7 | 80 |
| EG003 | Placebo | Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Ibuprofen 600 mg: Ibuprofen Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions. | 0 | 80 | 0 | 80 | 5 | 80 |
| Gastrointestinal complaint | Gastrointestinal disorders | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | Non-systematic Assessment |
|
| urinary complaint | General disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| Male |
|