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

NCT ID: NCT05151510

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2024-12-31

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.

Conditions

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Myofascial Trigger Point Pain Myofacial Pain

Keywords

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pain management emergency department trigger point injections lidocaine patches myofascial pain interventional pain medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Trigger point with 1% Lidocaine

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.

Group Type EXPERIMENTAL

Trigger point injection with 1% lidocaine

Intervention Type PROCEDURE

Previously discussed in prior section.

5% Lidocaine Patch

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.

Group Type ACTIVE_COMPARATOR

Lidocaine patch 5%

Intervention Type DRUG

Will place lidocaine patch onto skin overlaying point of maximal tenderness

Interventions

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Trigger point injection with 1% lidocaine

Previously discussed in prior section.

Intervention Type PROCEDURE

Lidocaine patch 5%

Will place lidocaine patch onto skin overlaying point of maximal tenderness

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Lee, MD

Role: PRINCIPAL_INVESTIGATOR

UCI Department of Emergency Medicine

Locations

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Emergency Room at UCI Medical Center

Orange, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jonathan B Lee, MD

Role: CONTACT

Phone: 9098963192

Email: [email protected]

Bharath Chakravarthy, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Jonathan Lee, MD

Role: primary

Bharath Chakravarthy, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 32712034 (View on PubMed)

Skootsky SA, Jaeger B, Oye RK. Prevalence of myofascial pain in general internal medicine practice. West J Med. 1989 Aug;151(2):157-60.

Reference Type BACKGROUND
PMID: 2788962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18992040 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2528826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22024326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19446144 (View on PubMed)

Other Identifiers

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UCI IRB HS# 2021-6439

Identifier Type: -

Identifier Source: org_study_id