Myofascial Trigger Point Pain, Myofacial Pain
Conditions
Keywords
pain management, emergency department, trigger point injections, lidocaine patches, myofascial pain, interventional pain medicine
Brief summary
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
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.
Interventions
PROCEDURETrigger point injection with 1% lidocaine
Previously discussed in prior section.
Will place lidocaine patch onto skin overlaying point of maximal tenderness
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| absolute change in Numerical Rating Scale (NRS) 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| use of other medications for treatment of pain including medications administered | From initiation of the study up to 5 days post discharge | How often and which medications did the patient require in emergency department and upon discharge to control their pain |
| disposition times | From initiation of the study up to the point the patient is discharged from the emergency department | Number of minutes it takes to discharge or admit the patient from first contact |
| satisfaction/experience surveys regarding their treatment | Immediately after the intervention is performed/administered | We will administer satisfaction/experience surveys to assess for any discomfort or relief from the intervention |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJonathan Lee, MD
UCI Department of Emergency Medicine
Outcome results
None listed