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Clinical Trials/NCT05151510
NCT05151510
Withdrawn
Phase 4

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

University of California, Irvine1 site in 1 country110 target enrollmentNovember 1, 2021

Overview

Phase
Phase 4
Intervention
Trigger point injection with 1% lidocaine
Conditions
Myofascial Trigger Point Pain
Sponsor
University of California, Irvine
Enrollment
110
Locations
1
Primary Endpoint
absolute change in Numerical Rating Scale (NRS) of pain
Status
Withdrawn
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
June 30, 2022
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jonathan B Lee

Resident Physician

University of California, Irvine

Eligibility Criteria

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
  • have an allergy to lidocaine
  • altered or deemed incapable of making informed consent
  • had signs of infection or skin breakdown over the trigger point.

Arms & Interventions

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.

Intervention: Trigger point injection with 1% lidocaine

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.

Intervention: Lidocaine patch 5%

Outcomes

Primary Outcomes

absolute change in Numerical Rating Scale (NRS) of pain

Time Frame: 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 Outcomes

  • disposition times(From initiation of the study up to the point the patient is discharged from the emergency department)
  • use of other medications for treatment of pain including medications administered(From initiation of the study up to 5 days post discharge)
  • satisfaction/experience surveys regarding their treatment(Immediately after the intervention is performed/administered)

Study Sites (1)

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