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

NCT05151510 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 20216439
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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%.

Conditions

Myofascial Trigger Point Pain; Myofacial Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (3)

• use of other medications for treatment of pain including medications administered

  From initiation of the study up to 5 days post discharge

• disposition times

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

• satisfaction/experience surveys regarding their treatment

  Immediately after the intervention is performed/administered

Study Arms (2)

Trigger point with 1% Lidocaine

EXPERIMENTAL

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.

Procedure: Trigger point injection with 1% lidocaine

5% Lidocaine Patch

ACTIVE COMPARATOR

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.

Drug: Lidocaine patch 5%

Interventions

Lidocaine patch 5% DRUG

Will place lidocaine patch onto skin overlaying point of maximal tenderness

5% Lidocaine Patch

Trigger point injection with 1% lidocaine PROCEDURE

Previously discussed in prior section.

Trigger point with 1% Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Emergency Room at UCI Medical Center

Orange, California, 92868, United States

Location

Related Publications (6)

• 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.

  PMID: 32712034 BACKGROUND

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

  PMID: 2788962 BACKGROUND

• 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.

  PMID: 18992040 BACKGROUND

• 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.

  PMID: 2528826 BACKGROUND

• 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.

  PMID: 22024326 BACKGROUND

• 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.

  PMID: 19446144 BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes; Facial Pain; Agnosia; Emergencies

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jonathan Lee, MD

  UCI Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Model Details: 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).

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: December 9, 2021
• Study Start: November 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 13, 2026

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)