Trigger Point Injections Versus Lidocaine Patch for Myofascial Pain in the Emergency Department

Study Overview
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Brief Summary
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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%.

Detailed Description
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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.

Official Title
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A Randomized Controlled Study Comparing Trigger Point Injections With 1% Lidocaine Versus 5% Lidocaine Patch for Myofascial Pain in the Emergency Department

Conditions
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Myofascial Trigger Point Pain, Myofacial Pain

Intervention / Treatment
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* Procedure: Trigger point injection with 1% lidocaine
* Drug: Lidocaine patch 5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Diagnosed with myofascial pain of the posterior neck or back. *The diagnosis of myofascial pain was based on established criteria of having a palpable taut band (trigger point) that when depressed reproduced the patient's pain. Exclusion Criteria: midline spinal tenderness evidence of radiculopathy pregnant have an allergy to lidocaine altered or deemed incapable of making informed consent had signs of infection or skin breakdown over the trigger point.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trigger point with 1% Lidocaine<br>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. | Procedure: Trigger point injection with 1% lidocaine<br>* Previously discussed in prior section.<br>|
| Active Comparator: 5% Lidocaine Patch<br>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. | Drug: Lidocaine patch 5%<br>* Will place lidocaine patch onto skin overlaying point of maximal tenderness<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain management, emergency department, trigger point injections, lidocaine patches, myofascial pain, interventional pain medicine