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Main researcher (Jonathan Lee) left the institution. Once he left, recruitment did not occur.
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The aim of this trial is to investigate the efficacy of trigger point injections with 1% lidocaine in reducing myofascial back and neck pain in the Emergency Department compared to lidocaine patches 5%.
After being informed about the study and the potential risks and benefits, all patients will be randomized into either the trigger point injection group with 1% lidocaine, or the 5% lidocaine patch group. Pain scores will be recorded while in the emergency department, and we will have a 5 day follow-up phone call to assess efficacy. Patients who present to UCI Department of Emergency medicine will be screened and recruited prospectively, and information regarding this study will be available on clinicaltrials.gov as a method of recruitment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trigger point with 1% Lidocaine | Experimental | The physician will withdraw 1cc of 1% lidocaine in a 25g needle, sterilely prep the field with a Chloraprep applicator, use index, and middle finger to squeeze the borders of the trigger point and raise the central aspect of the trigger point, insert the needle at 90-degree angle up to 5/8' deep, inject 1cc of the 1% lidocaine after ensuring needle is not in a blood vessel, removing the needle, and then covering the insertion site with a sterile bandage. |
|
| 5% Lidocaine Patch | Active Comparator | 5% lidocaine patch will be placed at the point of maximal tenderness upon palpation. Location of placement will be described and instructed by physician and placed by nursing staff. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trigger point injection with 1% lidocaine | Procedure | Previously discussed in prior section. |
|
| Measure | Description | Time Frame |
|---|---|---|
| absolute change in Numerical Rating Scale (NRS) of pain | Pain on a scale of 1-10. Minimum value is 1, maximum value is 10. Higher score means higher level of pain while lower score means lower level of pain. | 0 minutes and 20-minutes post- treatment, and every 30-60 minutes thereafter until discharge or admission and we will give the patient a hand out so that they can record their pain scores for up to 5 days after their emergency department visit. |
| Measure | Description | Time Frame |
|---|---|---|
| use of other medications for treatment of pain including medications administered | How often and which medications did the patient require in emergency department and upon discharge to control their pain | From initiation of the study up to 5 days post discharge |
| disposition times |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Lee, MD | UCI Department of Emergency Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Room at UCI Medical Center | Orange | California | 92868 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32712034 | Background | Yanuck J, Saadat S, Lee JB, Jen M, Chakravarthy B. Pragmatic Randomized Controlled Pilot Trial on Trigger Point Injections With 1% Lidocaine Versus Conventional Approaches for Myofascial Pain in the Emergency Department. J Emerg Med. 2020 Sep;59(3):364-370. doi: 10.1016/j.jemermed.2020.06.015. Epub 2020 Jul 22. | |
| 2788962 | Background |
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| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| D005157 | Facial Pain |
| D000377 | Agnosia |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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This will be a single-center, prospective, randomized, pragmatic trial carried out with patients that have a primary complaint of myofascial back and/or posterior neck pain. Upon presentation to the emergency department, if the patient is found to have myofascial pain, they will be approached by research personnel to be enrolled in the study. If the patient consents to be in the study, the patient will then be randomly assigned to either receive a trigger point injection or receive lidocaine patch (5%) therapy. The lidocaine patch therapy group cannot receive a trigger point injection. Randomization will occur in blocks of 2, using a Web- based randomization program (http://sealedenvelope.com).
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Given the trigger point injection is physician performed, and very different from placing a lidocaine patch, we cannot blind investigators nor the patient to the intervention. We will, however, blind our outcome assessors in regards to which intervention the patient had received.
| Lidocaine patch 5% | Drug | Will place lidocaine patch onto skin overlaying point of maximal tenderness |
|
Number of minutes it takes to discharge or admit the patient from first contact |
| From initiation of the study up to the point the patient is discharged from the emergency department |
| satisfaction/experience surveys regarding their treatment | We will administer satisfaction/experience surveys to assess for any discomfort or relief from the intervention | Immediately after the intervention is performed/administered |
| Skootsky SA, Jaeger B, Oye RK. Prevalence of myofascial pain in general internal medicine practice. West J Med. 1989 Aug;151(2):157-60. |
| 18992040 | Background | Scott NA, Guo B, Barton PM, Gerwin RD. Trigger point injections for chronic non-malignant musculoskeletal pain: a systematic review. Pain Med. 2009 Jan;10(1):54-69. doi: 10.1111/j.1526-4637.2008.00526.x. Epub 2008 Nov 5. |
| 2528826 | Background | Garvey TA, Marks MR, Wiesel SW. A prospective, randomized, double-blind evaluation of trigger-point injection therapy for low-back pain. Spine (Phila Pa 1976). 1989 Sep;14(9):962-4. doi: 10.1097/00007632-198909000-00008. |
| 22024326 | Background | Annaswamy TM, De Luigi AJ, O'Neill BJ, Keole N, Berbrayer D. Emerging concepts in the treatment of myofascial pain: a review of medications, modalities, and needle-based interventions. PM R. 2011 Oct;3(10):940-61. doi: 10.1016/j.pmrj.2011.06.013. |
| 19446144 | Background | Affaitati G, Fabrizio A, Savini A, Lerza R, Tafuri E, Costantini R, Lapenna D, Giamberardino MA. A randomized, controlled study comparing a lidocaine patch, a placebo patch, and anesthetic injection for treatment of trigger points in patients with myofascial pain syndrome: evaluation of pain and somatic pain thresholds. Clin Ther. 2009 Apr;31(4):705-20. doi: 10.1016/j.clinthera.2009.04.006. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| Aniline Compounds |
| D000588 | Amines |