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The purpose of this study is to see whether the combination of a muscle relaxant and anti-inflammatory drug is more effective at relieving pain in patients with neck strains or whiplash than either of the two medications alone.
Muscle relaxants have been used extensively for neck and back pain since muscle spasm is thought to play a role in the cycle of pain and spasm. However, prior studies have conflicting results regarding their additive effect when given in addition to analgesics such as the NSAIDs. Because they have the potential to lead to adverse events their efficacy should be clearly demonstrated before their routine use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclobenzaprine | Active Comparator |
| |
| Ibuprofen | Active Comparator |
| |
| Ibuprophen plus Cyclobenzaprine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclobenzaprine | Drug | 5 mg orally every 8 hours as needed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Daily for 1 week | |
| Use of Rescue Medications | the number of patients taking additional rescue medications beyond the study meds | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Resumption of Work | 1 week | |
| Resumption of Work or School | number of patients resuming regular activity the day following enrollment. | next day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| adam singer, md | Stony Brook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University | Stony Brook | New York | 11733 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cyclobenzaprine | |
| FG001 | Ibuprofen | |
| FG002 | Ibuprophen Plus Cyclobenzaprine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cyclobenzaprine | |
| BG001 | Ibuprofen | |
| BG002 | Ibuprophen Plus Cyclobenzaprine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Pain | Not Posted | Mean | Standard Deviation | mm on visual analog scale | Daily for 1 week | ||||||||||
| Secondary | Time to Resumption of Work | Not Posted | 1 week |
next day
th number of patients reporting an adverse event on the day following enrollment and each additional day for 1 week.
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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 | Cyclobenzaprine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Singer | Stony Brook U | 631 444 7856 | adam.singer@stonybrook.edu |
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| ID | Term |
|---|---|
| D014911 | Whiplash Injuries |
| ID | Term |
|---|---|
| D019838 | Neck Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C004704 | cyclobenzaprine |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Ibuprofen | Drug | Ibuprofen 400 mg every 8 hours as needed |
|
|
| Ibuprofen plus Cyclobenzaprine | Drug | Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed |
|
|
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary | Use of Rescue Medications | the number of patients taking additional rescue medications beyond the study meds | number of patients using additionl anlagesics on the day following enrollment | Posted | Number | participants | 24 hours |
|
|
|
| Secondary | Resumption of Work or School | number of patients resuming regular activity the day following enrollment. | Posted | Number | participants | next day |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Ibuprofen | 0 | 20 | 0 | 20 |
| EG002 | Ibuprophen Plus Cyclobenzaprine | 0 | 20 | 0 | 20 |
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