Myofascial Trigger Point PainPhase 4NCT05151510
Trigger Point Injections Versus Lidocaine Patch for Myofascial Pain in the Emergency Department
A Phase 4 study testing Trigger point injection with 1% lidocaine and Lidocaine patch 5% in people with Myofascial Trigger Point Pain and Myofacial Pain, run by University of California, Irvine at 1 site in United States.
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%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myofascial Trigger Point Pain, Myofacial Pain
- What is being tested?
- Trigger point injection with 1% lidocaine and Lidocaine patch 5%
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 30 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emergency Room at UCI Medical Center
Orange, California, 92868
About this study
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%.
Read the 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.
- Conditions
- Myofascial Trigger Point Pain, Myofacial Pain
- Being tested
- Trigger point injection with 1% lidocaine, Lidocaine patch 5%
- Keywords
- pain management, emergency department, trigger point injections, lidocaine patches, myofascial pain, interventional pain medicine
- Medical subject headings
- Myofascial Pain Syndromes, Facial Pain, Agnosia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigger point injection with 1% lidocaineProcedure or surgery
Previously discussed in prior section.
Lidocaine patch 5%Drug
Will place lidocaine patch onto skin overlaying point of maximal tenderness
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Lidocaine patch 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
How often and which medications did the patient require in emergency department and upon discharge to control their pain
Measured: From initiation of the study up to 5 days post discharge
disposition times
Number of minutes it takes to discharge or admit the patient from first contact
Measured: From initiation of the study up to the point the patient is discharged from the emergency department
satisfaction/experience surveys regarding their treatment
We will administer satisfaction/experience surveys to assess for any discomfort or relief from the intervention
Measured: Immediately after the intervention is performed/administered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Nov 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: Main researcher (Jonathan Lee) left the institution. Once he left, recruitment did not occur.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Myofascial Trigger Point PainStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan B Lee, University of California, Irvine
- Investigators
- Jonathan Lee, MD, Principal investigator, UCI Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151510
- Sponsor's protocol ID
- 20216439
- Status last verified
- Nov 2023
- First submitted
- 8 Sep 2021
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32712034Skootsky SA, Jaeger B, Oye RK. Prevalence of myofascial pain in general internal medicine practice. West J Med. 1989 Aug;151(2):157-60.
PubMed 2788962Scott 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.
PubMed 18992040Garvey 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.
PubMed 2528826Annaswamy 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.
PubMed 22024326Affaitati 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.
PubMed 19446144
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Comparing Trigger Point Injections With 1% Lidocaine Versus 5% Lidocaine Patch for Myofascial Pain in the Emergency Department
- ClinicalTrials.gov ID
- NCT05151510
- Acronym / sponsor ID
- 20216439
- Conditions
- Myofascial Trigger Point Pain, Myofacial Pain
- Keywords
- pain management, emergency department, trigger point injections, lidocaine patches, myofascial pain, interventional pain medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Main researcher (Jonathan Lee) left the institution. Once he left, recruitment did not occur.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Trigger point with 1% Lidocaine | Experimental | Procedure: Trigger point injection with 1% lidocaineThe 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 | Active comparator | Drug: Lidocaine patch 5%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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- midline spinal tenderness
- evidence of radiculopathy
- pregnant
- have an allergy to lidocaine
- altered or deemed incapable of making informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trigger point injection with 1% lidocainePreviously discussed in prior section. | Procedure or surgery | Trigger point with 1% Lidocaine |
| Lidocaine patch 5%Will place lidocaine patch onto skin overlaying point of maximal tenderness | Drug | 5% Lidocaine Patch |
Primary outcome
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.
3 secondary outcomes
use of other medications for treatment of pain including medications administered
Time frame: From initiation of the study up to 5 days post discharge
disposition times
Time frame: From initiation of the study up to the point the patient is discharged from the emergency department
satisfaction/experience surveys regarding their treatment
Time frame: Immediately after the intervention is performed/administered
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 32712034Yanuck 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.
- Background: PubMed 2788962Skootsky SA, Jaeger B, Oye RK. Prevalence of myofascial pain in general internal medicine practice. West J Med. 1989 Aug;151(2):157-60.
- Background: PubMed 18992040Scott 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.
- Background: PubMed 2528826Garvey 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.
- Background: PubMed 22024326Annaswamy 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.
- Background: PubMed 19446144Affaitati 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Lee, MD principal investigator
UCI Department of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trigger point injection with 1% lidocaine and Lidocaine patch 5% in people with Myofascial Trigger Point Pain and Myofacial Pain, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05151510, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.