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

Primary Purpose

Myofascial Trigger Point Pain, Myofacial Pain

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Trigger point injection with 1% lidocaine

Lidocaine patch 5%

About this trial

This is an interventional treatment trial for Myofascial Trigger Point Pain focused on measuring pain management, emergency department, trigger point injections, lidocaine patches, myofascial pain, interventional pain medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Emergency Room at UCI Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trigger point with 1% Lidocaine

5% Lidocaine Patch

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

disposition times

Number of minutes it takes to discharge or admit the patient from first contact

satisfaction/experience surveys regarding their treatment

We will administer satisfaction/experience surveys to assess for any discomfort or relief from the intervention

Full Information

NCT ID

NCT05151510

First Posted

September 8, 2021

Last Updated

December 8, 2021

Sponsor

University of California, Irvine

1. Study Identification

Unique Protocol Identification Number

NCT05151510

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myofascial Trigger Point Pain, Myofacial Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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

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.

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Trigger point with 1% Lidocaine

Arm Type

Experimental

Arm Description

Arm Title

5% Lidocaine Patch

Arm Type

Active Comparator

Arm Description

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 Type

Procedure

Intervention Name(s)

Trigger point injection with 1% lidocaine

Intervention Description

Previously discussed in prior section.

Intervention Type

Drug

Intervention Name(s)

Lidocaine patch 5%

Intervention Description

Will place lidocaine patch onto skin overlaying point of maximal tenderness

Primary Outcome Measure Information:

Title

absolute change in Numerical Rating Scale (NRS) of pain

Description

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.

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.

Secondary Outcome Measure Information:

Title

use of other medications for treatment of pain including medications administered

Description

How often and which medications did the patient require in emergency department and upon discharge to control their pain

Time Frame

From initiation of the study up to 5 days post discharge

Title

disposition times

Description

Number of minutes it takes to discharge or admit the patient from first contact

Time Frame

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

Title

satisfaction/experience surveys regarding their treatment

Description

We will administer satisfaction/experience surveys to assess for any discomfort or relief from the intervention

Time Frame

Immediately after the intervention is performed/administered

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jonathan B Lee, MD

Phone

9098963192

jonbryanlee@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Bharath Chakravarthy, MD

bchakrav@uci.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Lee, MD

Organizational Affiliation

UCI Department of Emergency Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emergency Room at UCI Medical Center

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jonathan Lee, MD

Phone

909-896-3192

jonbryanlee@gmail.com

First Name & Middle Initial & Last Name & Degree

Bharath Chakravarthy, MD

bchakrav@hs.uci.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32712034

Citation

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.

Results Reference

background

PubMed Identifier

2788962

Citation

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

Results Reference

background

PubMed Identifier

18992040

Citation

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.

Results Reference

background

PubMed Identifier

2528826

Citation

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.

Results Reference

background

PubMed Identifier

22024326

Citation

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.

Results Reference

background

PubMed Identifier

19446144

Citation

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.

Results Reference

background

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

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