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

Myofascial Trigger Point Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05151510
• Other study ID #: UCI IRB HS# 2021-6439
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: December 2021
• Source: University of California, Irvine
• Contact: Jonathan B Lee, MD
• Phone: 9098963192
• Email: jonbryanlee[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Facial Pain
• Myofacial Pain
• Myofascial Pain Syndromes
• Myofascial Trigger Point Pain

Intervention

Procedure:
• Trigger point injection with 1% lidocaine
Previously discussed in prior section.

Drug:
• Lidocaine patch 5%
Will place lidocaine patch onto skin overlaying point of maximal tenderness

Locations

Country	Name	City	State
United States	Emergency Room at UCI Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	From initiation of the study up to 5 days post discharge
Secondary	disposition times	Number of minutes it takes to discharge or admit the patient from first contact	From initiation of the study up to the point the patient is discharged from the emergency department
Secondary	satisfaction/experience surveys regarding their treatment	We will administer satisfaction/experience surveys to assess for any discomfort or relief from the intervention	Immediately after the intervention is performed/administered