Erector Spinae Plane Block Versus Trigger Point Injection for Chronic Thoracic Myofascial Pain

Ultrasound-guided Erector Spinae Plane (ESP) Block Versus Trigger Point Injection (TPI) for Chronic Thoracic Myofascial Pain: A Randomized Controlled Trial

Chronic thoracic (mid-back) pain can be difficult to treat, and there is limited evidence to guide the use of injection therapies for pain arising from muscles and surrounding soft tissues. Two commonly used treatments are trigger point injections (TPI) and erector spinae plane (ESP) blocks, but no studies have directly compared their effectiveness for chronic thoracic myofascial pain. The purpose of this study is to compare pain relief, physical function, emotional well-being, patient satisfaction, and safety following treatment with either an ESP block or TPI. Participants will be randomly assigned to receive one of the two treatments. Researchers will follow participants for up to 12 weeks after the procedure and collect information through questionnaires and pain assessments.

Study Overview

• Status: Recruiting
• Conditions: Back Pain
• Intervention / Treatment: Drug: Erector Spinae Plane (ESP) Block with 0.5% Plain Bupivacaine; Drug: Trigger Point Injection (TPI) with 0.5% Plain Bupivacaine

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ryan D'Souza, MD; Phone Number: 507-284-9696; Email: dsouza.ryan@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Not yet recruiting
      • Mayo Clinic
      • Contact: Eva Kubrova, MD; Phone Number: 904-956-2043; Email: kubrova.eva@mayo.edu
      • Principal Investigator: Eva Kubrova, MD
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Not yet recruiting
      • University of Maryland
      • Contact: Jay Karri, MD; Phone Number: 410-706-3100; Email: jkarri@som.umaryland.edu
      • Principal Investigator: Jay Karri, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Ryan D'Souza, MD
      • Contact: Ryan D'Souza, MD; Phone Number: 507-284-9696; Email: dsouza.ryan@mayo.edu
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Not yet recruiting
      • The Ohio State University Wexner Medical Center
      • Contact: Nasir Hussain, MD; Phone Number: 614-293-8000; Email: nasir.hussain@osumc.edu
      • Principal Investigator: Nasir Hussain, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • MD Anderson Cancer Center
      • Principal Investigator: Saba Javed, MD
      • Contact: Saba Javed, MD; Phone Number: 877-632-6789; Email: sjaved@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18-80 years
• Chronic thoracic myofascial pain lasting at least three months
• Pain intensity of ≥4 on 11-point NRS
• At least two of three following conditions: Focal thoracic paraspinal pain, palpable taut band, referred pain pattern with palpation

Exclusion Criteria:

• Thoracic radiculopathy
• Cervical myelopathy with neurological deficit
• Prior cervicothoracic spine surgery
• Pregnancy or lactation
• Contraindication to local anesthetic
• Active malignancy
• Fibromyalgia
• BMI >40 kg/m2
• Workers' compensation or active litigation related to thoracic pain
• Acute herpes zoster or history of postherpetic neuralgia involving thoracic dermatomes
• Current opioid use >50 morphine milligram equivalents daily
• Severe psychiatric or cognitive disorders, specifically history of schizophrenia, chronic psychotic disorders, dementia
• History of substance use disorder
• Inability to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erector Spinae Plane (ESP) Block; Participants will receive an ultrasound-guided thoracic erector spinae plane (ESP) block at the thoracic level corresponding to the location of maximal pain. Under ultrasound guidance, a 22-gauge needle will be advanced into the fascial plane deep to the erector spinae muscle and superficial to the transverse process. Participants will receive 5 mL of 0.5% plain bupivacaine per side, with bilateral injections performed when clinically indicated for bilateral thoracic pain.	Drug: Erector Spinae Plane (ESP) Block with 0.5% Plain Bupivacaine; Participants will receive an ultrasound-guided thoracic erector spinae plane (ESP) block at the thoracic level corresponding to the location of maximal pain. Under ultrasound guidance, a 22-gauge needle will be advanced into the fascial plane deep to the erector spinae muscle and superficial to the transverse process. Participants will receive 5 mL of 0.5% plain bupivacaine per side, with bilateral injections performed when clinically indicated for bilateral thoracic pain.
Active Comparator: Trigger Point Injection (TPI); Participants will receive ultrasound-guided trigger point injection(s) into the thoracic paraspinal musculature at the site(s) of maximal tenderness. Under ultrasound guidance, 0.5% plain bupivacaine will be injected in volumes of 1-2 mL per injection site, with a maximum total volume of 5 mL per side and up to five injection sites per laterality.	Drug: Trigger Point Injection (TPI) with 0.5% Plain Bupivacaine; Participants will receive ultrasound-guided trigger point injection(s) into the thoracic paraspinal musculature at the site(s) of maximal tenderness. Under ultrasound guidance, 0.5% plain bupivacaine will be injected in volumes of 1-2 mL per injection site, with a maximum total volume of 5 mL per side and up to five injection sites per laterality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale (NRS) Pain Score	A Numeric Rating Scale (NRS) for pain is a patient-reported item regarding the level of pain experienced and is measured on a Likert scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable".	baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Oswestry Disability Index	Oswestry Disability Index (ODI) is a validated 10-item questionnaire assessing functional limitations in daily activities across spinal disorders, with total scores ranging from 0 to 100, where higher scores indicate greater disability.	baseline, 6 weeks
Center for Epidemiologic Studies Depression Scale (CES-D)	Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item questionnaire with scores ranging from 0 to 60, with higher scores indicating greater depressive symptom burden.	baseline, 6 weeks
Pain Catastrophizing Scale (PCS)	The PCS is a 13-item instrument measuring catastrophic thinking related to pain, with scores ranging from 0 to 52, and scores of 30 or higher indicating clinically significant levels of catastrophizing.	baseline, 6 weeks
Patient Global Impression of Change (PGIC)	The PGIC questionnaire is a 7-point Likert scale ranging from "very much worse" to "very much improved." This measure provides a global assessment of treatment benefit from the patient's perspective.	6 weeks
Repeat Injections	This measure will assess the number of patients requiring repeat injection(s) within 12 weeks following the index procedure. Measurement: Binary outcome (yes/no), obtained via follow-up assessment of medical record review (no patient questionnaire).	12 weeks
Adverse Events	We will assess the occurrence of procedure-related adverse events within 6 weeks following the index procedure. This will involve categorical recording of adverse events including but not limited to: injection site pain, hematoma, infection, vasovagal reaction, allergic reaction, pneumothorax, and new or worsening neurologic symptoms. All adverse events will be recorded and categorized according to severity and relatedness to the procedure.	Day 0 (procedure day), 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasciculation (in Trigger Point Injection Cohort Only)	Proceduralist will document occurrence (yes/no) of muscle fasciculation while performing trigger point injection.	Day 0 (procedure day)
Taut band Visualization (in Trigger Point Injection Cohort Only)	The proceduralist will document ultrasound visualization of a taut band (yes/no) while performing trigger point injection only.	Day 0 (procedure day)
Numeric Rating Scale (NRS) Pain Score During and After Injection	A Numeric Rating Scale (NRS) for pain is a patient-reported item regarding the level of pain experienced and is measured on a Likert scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable". Participants will be asked to rate their worst injection pain experienced during the procedure, and also to rate their immediate post-procedural pain intensity.	Day 0 (procedure day)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: M.D. Anderson Cancer Center; University of Maryland, Baltimore; Ohio State University
• Investigators: Principal Investigator: Ryan D'Souza, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 30, 2029

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Erector spinae plane block; ESP block; Trigger point injection; myofascial pain; thoracic back pain; thoracic myofascial pain; TPI
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain; Behavioral Disciplines and Activities; Digestive System and Oral Physiological Phenomena; Behavioral Sciences; Dentistry; Dental Physiological Phenomena; Dental Occlusion; Parapsychology
• Other Study ID Numbers: 26-004708

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No