What side effects are associated with this type of intervention?

Common treatments for Myofascial Pain Syndrome, such as trigger point injections with 1% lidocaine and lidocaine patches, are generally well-tolerated but can have side effects. These may include localized pain or discomfort at the injection site, temporary numbness, bruising, and swelling. In rare cases, patients may experience allergic reactions, dizziness, or systemic toxicity if the lidocaine is absorbed in large amounts. It is important to discuss these potential side effects with a healthcare provider to ensure safe and effective treatment.

What prior FDA approvals exist?

The FDA has approved various local anesthetics for the treatment of Myofascial Pain Syndrome, including lidocaine. Lidocaine, often used in trigger point injections, provides localized pain relief by blocking sodium channels and inhibiting nerve signal transmission. Other related drugs include bupivacaine and mepivacaine, which are also local anesthetics used for similar purposes. These treatments are commonly employed to manage pain by directly targeting the affected areas, thereby reducing muscle pain and discomfort.

What other types of research exist?

Promising novel alternatives to Trigger Point Injections with 1% Lidocaine for Myofascial Pain Syndrome include: 1) Lidocaine patches 5%, which provide localized pain relief with less invasiveness. 2) Botulinum toxin injections, which have shown efficacy in reducing muscle pain and spasms. 3) Acupuncture, which has been supported by systematic reviews for its effectiveness in pain management. 4) Extracorporeal shock wave therapy, which has been studied for its potential to alleviate chronic musculoskeletal pain. 5) Prolotherapy, which involves injecting irritant solutions to stimulate healing and has shown promise in pilot studies.

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Local Anesthetic

Trigger Point Injections vs Lidocaine Patch for Myofascial Pain

Phase 4

Waitlist Available

Led By Jonathan Lee, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years or older

Be older than 18 years old

Must not have

Midline spinal tenderness

Altered or deemed incapable of making informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from initiation of the study up to the point the patient is discharged from the emergency department

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing two methods to relieve muscle pain in patients with back and neck pain in the Emergency Department. One method uses injections of a numbing medicine called lidocaine directly into painful muscle spots, while the other uses patches that release lidocaine through the skin. Both aim to reduce pain by numbing the affected area. Lidocaine is a well-recognized medium-acting local anesthetic used for managing both acute and chronic pain in various medical settings.

Who is the study for?

This trial is for adults with myofascial pain in the neck or back, identified by a specific tender spot that recreates their pain when pressed. It's not for those with spinal tenderness, nerve root pain symptoms (radiculopathy), pregnant individuals, people allergic to lidocaine, those unable to consent, or if there's infection/skin issues at the pain site.

What is being tested?

The study compares two treatments for easing myofascial back and neck pain in emergency settings: one group receives trigger point injections with 1% lidocaine directly into painful spots; another gets patches containing 5% lidocaine applied on the skin over these areas.

What are the potential side effects?

Possible side effects include discomfort at injection sites for those getting injections and skin irritation where patches are applied. Lidocaine can sometimes cause numbness of the area, tingling sensations, dizziness or an allergic reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have pain in the middle of my spine.

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I am capable of understanding and consenting to participate.

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I have symptoms caused by a pinched nerve in my spine.

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I have signs of infection or skin issues over a specific area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

absolute change in Numerical Rating Scale (NRS) of pain

Secondary study objectives

disposition times

satisfaction/experience surveys regarding their treatment

use of other medications for treatment of pain including medications administered

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Trigger point with 1% LidocaineExperimental Treatment1 Intervention

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 II: 5% Lidocaine PatchActive Control1 Intervention

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Myofascial Pain Syndrome, such as trigger point injections with 1% lidocaine, work by providing localized pain relief through the inhibition of nerve signal transmission. Lidocaine blocks sodium channels on nerve cells, preventing the propagation of pain signals. This mechanism is particularly important for MPS patients as it directly targets the hyperactive nerve signals that cause muscle pain and tenderness, offering immediate and effective pain relief.

Antihyperalgesic effect of tetrodotoxin in rat models of persistent muscle pain.Differential effects of low dose lidocaine on C-fiber classes in humans.Long-term effect of sciatic nerve block with slow-release lidocaine in a rat model of postoperative pain.