Acute Musculoskeletal DiseasePhase 3NCT03571737
Efficacy of Lidocaine Patch in Acute Musculoskeletal Pain in the Emergency Department
A Phase 3 study testing Ibuprofen and Lidocaine Patch 4% in people with Acute Musculoskeletal Disease and Sprains, run by East Carolina University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Musculoskeletal Disease, Sprains, Sprains and Strains
- What is being tested?
- Ibuprofen and Lidocaine Patch 4%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2018to 30 Jan 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject's age is greater than or equal to 18 years old
- Subject is able to speak English
- Subject has chief complaint of musculoskeletal pain lasting less than or equal to 7 days
- Subject's area of greatest pain isolated to one body part
- Subject does not have prior Emergency Department visits recorded on electronic medical records for the chief complaint
Who cannot join
- Subject's age is less than 18 years old
- Subject is pregnant or breastfeeding patients
- Subject cannot speak English
- Subject has multiple traumatic injuries or injury requiring consultation with the trauma service per study facility's guidelines
- Subject has cellulitis or infection overlying the injuries
- Subject has open wound overlying the injuries
Show all 17Show fewer
- Subject's chief complaint is caused by penetrating injury
- Subject has absolute contraindications to study medications, including anaphylaxis to lidocaine or nonsteroidal antiinflammatory drugs, history of active GI bleeding or recent coronary artery bypass graft surgery precluding nonsteroidal antiinflammatory medications, severe hepatic disease (hepatitis, cirrhosis in current chart or prior history or elevation in liver function tests to clinically significant levels in past 6 months), severe kidney disease (Creatinine clearance less than 30 milliliters or history of chronic kidney disease stage 3 or worse), congestive heart failure.
- Subject has medication contraindications such as concurrent use of medications listed: Alcuronium, Amphotericin B, Amprenavir, Atracurium, Cimetidine, Edrophonium, Enflurane, Fosphenytoin, Halothane, Nadolol, Oxprenolol, Pentazocine, Propafenone
- Subject is on class I antiarrhythmics therapy (including lidocaine, procainamide, disopyramide etc)
- Subject has injuries requiring splint/casting where patient may not be able to reach the area of greatest pain to apply and reapply the patch
- Subject has prior history of chronic pain in the affected area (defined as greater than or equal to 6 weeks of pain)
- Subject has received opioid medication in triage area or within 4 hours of initial treatment
- Subject is unable to give pain scores due to mental status
- Subject's initial numerical pain scale score of 0 (which would constitute "no pain" on the scale)
- Subject requires opiate medication or muscle relaxants (Flexeril, Valium, Tizanidine, Robaxin etc) during the initial visit to Emergency department at the discretion of the provider.
- Subjects who received less than 800 milligram oral dosage of ibuprofen in triage
Trial locations and contacts
1 site in 1 country.
United States1 site
Vidant Medical Center
Greenville, North Carolina, 27834
About this study
Official title: Efficacy of Lidocaine Patch in Acute Musculoskeletal Pain in the Emergency Department: A Prospective Randomized Controlled Study
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.
Read the detailed description
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.
- Conditions
- Acute Musculoskeletal Disease, Sprains, Sprains and Strains, Injuries, Emergencies, Trauma
- Being tested
- Ibuprofen, Lidocaine Patch 4%
- Keywords
- acute pain, muscle strain, muscle sprain, injury, emergency department
- Medical subject headings
- Sprains and Strains, Wounds and Injuries, Emergencies, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Motrin, Advil
Ibuprofen tablet
Lidocaine Patch 4%Drug
Also called Lidocaine Pain Relief Patch
Lidocaine patch
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Active comparator | Ibuprofen 800mg every 8 hours for 3 days Receives: Drug: Ibuprofen |
| 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 Receives: Drug: Ibuprofen; Drug: Lidocaine Patch 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes
Secondary outcomes (1)
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start23 Jun 2018
- Primary completion30 Dec 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Musculoskeletal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stahl, Jennifer, East Carolina University
- Investigators
- Jennifer Stahl, MD, Study director, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571737
- Sponsor's protocol ID
- UMCIRB 17-001594
- Status last verified
- Mar 2024
- First submitted
- 2 Jun 2018
- Last updated
- 25 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lidocaine Patch in Acute Musculoskeletal Pain in the Emergency Department: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03571737
- Acronym / sponsor ID
- UMCIRB 17-001594
- Conditions
- Acute Musculoskeletal Disease, Sprains, Sprains and Strains, Injuries, Emergencies, Trauma
- Keywords
- acute pain, muscle strain, muscle sprain, injury, emergency department
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 23 Jun 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Posted 25 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Active comparator | Drug: IbuprofenIbuprofen 800mg every 8 hours for 3 days |
| Ibuprofen & Lidocaine Patch 4% | Experimental | Drug: Ibuprofen, Drug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject's age is greater than or equal to 18 years old
- Subject is able to speak English
- Subject has chief complaint of musculoskeletal pain lasting less than or equal to 7 days
- Subject's area of greatest pain isolated to one body part
- Subject does not have prior Emergency Department visits recorded on electronic medical records for the chief complaint
Key exclusion criteria (17 listed)
- Subject's age is less than 18 years old
- Subject is pregnant or breastfeeding patients
- Subject cannot speak English
- Subject has multiple traumatic injuries or injury requiring consultation with the trauma service per study facility's guidelines
- Subject has cellulitis or infection overlying the injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenAlso: Motrin, AdvilIbuprofen tablet | Drug | Ibuprofen, Ibuprofen & Lidocaine Patch 4% |
| Lidocaine Patch 4%Also: Lidocaine Pain Relief PatchLidocaine patch | Drug | Ibuprofen & Lidocaine Patch 4% |
Primary outcome
Change in Numerical Pain Rating Scale
Time frame: 60 minutes
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.
1 secondary outcome
Number of Participants With a Return Visit for Same Chief Complaint
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Stahl, MD study director
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibuprofen and Lidocaine Patch 4% in people with Acute Musculoskeletal Disease and Sprains, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numerical Pain Rating Scale (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.