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
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%.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Emergency Room at UCI Medical Center | Orange | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Irvine |
United States,
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
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 |
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