Recruiting

ESP vs. TPI

Sponsor:

Mayo Clinic

Code:

NCT07632820

Conditions

Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Trigger Point Injection (TPI) with 0.5% Plain Bupivacaine

Study Details

Brief summary:

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.

Conditions

Back Pain

Study ID

NCT07632820

Start date

Aug 13, 2026

Status verified date

Sep, 2026

Completion date

Aug 30, 2029

Anticipated

Primary completion date

Aug 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Numeric Rating Scale (NRS) Pain Score [ Time Frame: baseline, 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Ryan D'Souza, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • thoracic back pain
  • myofascial pain
  • thoracic myofascial pain
  • Trigger point injection
  • Erector spinae plane block
  • TPI
  • ESP block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-09.