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Low back pain is a common cause of visit to emergency department. It is not clear if skeletal muscle relaxants are of benefit for patients with acute low back pain. This is a randomized study to determine if skeletal muscle relaxants, when combined with naproxen, improve outcomes more than naproxen alone
Patients with acute, non-traumatic, non-radicular low back pain will be enrolled at the time of discharge from the emergency department. Participants will be followed by telephone one week and 3 months after the ED visit
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Naproxen 500mg tablets taken twice per day + placebo. Placebo dose will be either 1 capsule orally twice per day or 1 or 2 capsules orally, thrice per day Naproxen 500mg po BID x 10 days #20 + Placebo |
|
| Orphenadrine | Active Comparator | Naproxen 500mg, orally twice per day + orphenadrine 100mg, orally twice per day for 10 days Naproxen 500mg po BID x 10 days #20 + Orphenadrine |
|
| Methocarbamol | Active Comparator | Naproxen 500mg tablets, orally twice per day + methocarbamol 750mg, orally as 1 or 2 tabs, thrice per day Naproxen 500mg po BID x 10 days #20 + Methocarbamol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orphenadrine | Drug | Orphenadrine 100mg PO BID x 7 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Impairment as Measured on the Roland Morris Disability Questionnaire | Change in Roland Morris Disability Questionnaire between baseline and 1 week. The low back pain functional disability scale is the RMDQ. The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Cases of Moderate or Severe LBP | Participants with moderate to severe low back pain after treatment as report on the following ordinal scale: severe, moderate, mild, or none | 1 week |
| Medications--Patient Self Report of Medication Use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin W Friedman, MD, MS | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29089169 | Derived | Friedman BW, Cisewski D, Irizarry E, Davitt M, Solorzano C, Nassery A, Pearlman S, White D, Gallagher EJ. A Randomized, Double-Blind, Placebo-Controlled Trial of Naproxen With or Without Orphenadrine or Methocarbamol for Acute Low Back Pain. Ann Emerg Med. 2018 Mar;71(3):348-356.e5. doi: 10.1016/j.annemergmed.2017.09.031. Epub 2017 Oct 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days |
| FG001 | Orphenadrine | Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days |
| FG002 | Methocarbamol | Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days |
| BG001 | Orphenadrine |
| 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 | Functional Impairment as Measured on the Roland Morris Disability Questionnaire | Change in Roland Morris Disability Questionnaire between baseline and 1 week. The low back pain functional disability scale is the RMDQ. The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment. | Posted | Mean | 95% Confidence Interval | units on a scale | 1 week |
|
1 week after treatment
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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 | Placebo | Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsy | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin W. Friedman, MD, MS | Montefiore Medical Center | (718)920-6266 | 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 | Jan 27, 2016 | Apr 30, 2018 | 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 |
|---|---|
| D009966 | Orphenadrine |
| D018680 | Cholinergic Antagonists |
| D008721 | Methocarbamol |
| D009288 | Naproxen |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
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| Methocarbamol | Drug | Methocarbamol 750mg 1-2 tabs po TID x 7 days |
|
|
| Naproxen | Drug | Naproxen 500mg PO BID x 7 days |
|
|
| Placebo | Drug | 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days |
|
Participants still using medication such as analgesics for LBP after treatment
| 1 week |
| Patient Satisfaction With Treatment | The number of participants with affirmative response to the following question: Do you want the same medication combination during a subsequent episode of LBP. This is a patient-centered outcome that allows each individual to determine the desirability of the intervention. | 1 week |
Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days |
| BG002 | Methocarbamol | Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days |
| 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 |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Duration of Back Pain Prior to Study | Median | Inter-Quartile Range | Hours |
|
| Orphenadrine |
Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days |
| OG002 | Methocarbamol | Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days |
|
|
| Secondary | Cases of Moderate or Severe LBP | Participants with moderate to severe low back pain after treatment as report on the following ordinal scale: severe, moderate, mild, or none | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Medications--Patient Self Report of Medication Use | Participants still using medication such as analgesics for LBP after treatment | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Patient Satisfaction With Treatment | The number of participants with affirmative response to the following question: Do you want the same medication combination during a subsequent episode of LBP. This is a patient-centered outcome that allows each individual to determine the desirability of the intervention. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| 0 |
| 76 |
| 0 |
| 76 |
| 9 |
| 76 |
| EG001 | Orphenadrine | Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days | 0 | 78 | 0 | 78 | 8 | 78 |
| EG002 | Methocarbamol | Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days | 0 | 80 | 0 | 80 | 14 | 80 |
| dizz | Nervous system disorders | Non-systematic Assessment |
|
| Stomach irritation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D018678 | Cholinergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D048448 | Phenylcarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006140 | Guaifenesin |
| D006139 | Guaiacol |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| Male |
|