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This study evaluates the addition of a lidocaine patch to ibuprofen in the treatment of acute musculoskeletal pains. Half of the participants will get only ibuprofen for their pain, while other half will receive lidocaine patch plus the ibuprofen. After addition of the pain medications, the participants will be followed for their pain scores and return visits.
Ibuprofen and other nonsteroidal antiinflammatory pain medications have been traditionally used for relief of mild to moderate acute musculoskeletal pains. However, if this medication did not work, a different modality for pain control would be added to the original regimen. In recent times, lidocaine patch has been introduced as a separate modality for pain control. This medication is thought to help by selectively inhibiting voltage-gated sodium channels in nociceptors involved in pain response. Given the separate modality, it would be prudent to see whether the addition of lidocaine patch to the ibuprofen would help relieve the pain more so than the antiinflammatory-only regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Active Comparator | Ibuprofen 800mg every 8 hours for 3 days |
|
| Ibuprofen & Lidocaine Patch 4% | Experimental | Ibuprofen 800mg every 8 hours for 3 days and Lidocaine patch 4% 1 patch applied for 12 hours then removed for 12 hours, for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | Ibuprofen tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Numerical Pain Rating Scale | Change in self-reported pain intensity level. Baseline will be prior to intervention, and change will be assessed 60 minutes after intervention. Each item is scored 0-10 (0=No pain, 10= Worst pain possible). Higher number is worse outcome while lower number is better outcome. | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Return Visit for Same Chief Complaint | Questionnaire (Yes or No) of whether a return visit to either the emergency department or primary care offices occurred within 1 week for same chief complaint from the initial visit | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Stahl, MD | East Carolina University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vidant Medical Center | Greenville | North Carolina | 27834 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen- Control | Ibuprofen 800mg every 8 hours for 3 days Ibuprofen: Ibuprofen tablet |
| FG001 | Ibuprofen & Lidocaine Patch 4%- Experimental | Ibuprofen 800mg every 8 hours for 3 days and Lidocaine patch 4% 1 patch applied for 12 hours then removed for 12 hours, for 3 days Ibuprofen: Ibuprofen tablet Lidocaine Patch 4%: Lidocaine patch |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen | Ibuprofen 800mg every 8 hours for 3 days Ibuprofen: Ibuprofen tablet |
| BG001 | Ibuprofen & Lidocaine Patch 4% | Ibuprofen 800mg every 8 hours for 3 days and Lidocaine patch 4% 1 patch applied for 12 hours then removed for 12 hours, for 3 days Ibuprofen: Ibuprofen tablet Lidocaine Patch 4%: Lidocaine patch |
| 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 Numerical Pain Rating Scale | Change in self-reported pain intensity level. Baseline will be prior to intervention, and change will be assessed 60 minutes after intervention. Each item is scored 0-10 (0=No pain, 10= Worst pain possible). Higher number is worse outcome while lower number is better outcome. | Posted | Mean | 95% Confidence Interval | score on a scale | 60 minutes |
|
From study enrollment to 7 days post-enrollment
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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- Control | Ibuprofen 800mg every 8 hours for 3 days Ibuprofen: Ibuprofen tablet |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Stahl | Brody School of Medicine @ East Carolina University | 2527442570 | stahlj@ecu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 12, 2018 | Mar 2, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2018 | Mar 3, 2024 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D004630 | Emergencies |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Lidocaine Patch 4% | Drug | Lidocaine patch |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Initial Pain Score | Pain score is assessed with a 10 point Likert pain scale. Scale range 0 to 10. Lower score is better outcome, higher score is worse outcome. Total is the combined score for both intervention groups. In this case the mean average of scores for all participants (including both intervention groups) with range score 0 to 10. Lower score is better outcome, higher score is worse outcome | Mean | Standard Deviation | units on a scale |
|
|
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| Secondary | Number of Participants With a Return Visit for Same Chief Complaint | Questionnaire (Yes or No) of whether a return visit to either the emergency department or primary care offices occurred within 1 week for same chief complaint from the initial visit | Posted | Count of Participants | Participants | 1 week |
|
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Ibuprofen & Lidocaine Patch 4%- Experimental | Ibuprofen 800mg every 8 hours for 3 days and Lidocaine patch 4% 1 patch applied for 12 hours then removed for 12 hours, for 3 days Ibuprofen: Ibuprofen tablet Lidocaine Patch 4%: Lidocaine patch | 0 | 10 | 0 | 10 | 0 | 10 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |