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NCT Number: NCT07632820

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

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.

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Key information

Conditions

Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erector Spinae Plane (ESP) Block with 0.5% Plain Bupivacaine

Drug

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.

Trigger Point Injection (TPI) with 0.5% Plain Bupivacaine

Drug

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.

Primary outcomes

  1. Numeric Rating Scale (NRS) Pain Score

    Time frame: baseline, 6 weeks

    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".

Secondary outcomes

  1. Modified Oswestry Disability Index

    Time frame: baseline, 6 weeks

    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.

  2. Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: baseline, 6 weeks

    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.

  3. Pain Catastrophizing Scale (PCS)

    Time frame: baseline, 6 weeks

    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.

  4. Patient Global Impression of Change (PGIC)

    Time frame: 6 weeks

    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.

  5. Repeat Injections

    Time frame: 12 weeks

    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).

  6. Adverse Events

    Time frame: Day 0 (procedure day), 6 weeks

    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.

Other outcomes

  1. Fasciculation (in Trigger Point Injection Cohort Only)

    Time frame: Day 0 (procedure day)

    Proceduralist will document occurrence (yes/no) of muscle fasciculation while performing trigger point injection.

  2. Taut band Visualization (in Trigger Point Injection Cohort Only)

    Time frame: Day 0 (procedure day)

    The proceduralist will document ultrasound visualization of a taut band (yes/no) while performing trigger point injection only.

  3. Numeric Rating Scale (NRS) Pain Score During and After Injection

    Time frame: Day 0 (procedure day)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ryan D'Souza, MD

CONTACT

[email protected]

507-284-9696

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • M.D. Anderson Cancer Center
  • Ohio State University
  • University of Maryland, Baltimore

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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