NCT07632820

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
38mo left

Started Aug 2026

Typical duration for phase_4

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2029

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

June 3, 2026

Last Update Submit

June 3, 2026

Conditions

Back Pain

Keywords

thoracic back painmyofascial painthoracic myofascial painTrigger point injectionErector spinae plane blockTPIESP block

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Modified Oswestry Disability Index

    baseline, 6 weeks

  • Center for Epidemiologic Studies Depression Scale (CES-D)

    baseline, 6 weeks

  • Pain Catastrophizing Scale (PCS)

    baseline, 6 weeks

  • Patient Global Impression of Change (PGIC)

    6 weeks

  • Repeat Injections

    12 weeks

  • +1 more secondary outcomes

Other Outcomes (3)

  • Fasciculation (in Trigger Point Injection Cohort Only)

    Day 0 (procedure day)

  • Taut band Visualization (in Trigger Point Injection Cohort Only)

    Day 0 (procedure day)

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

    Day 0 (procedure day)

Study Arms (2)

Erector Spinae Plane (ESP) Block

EXPERIMENTAL

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

Trigger Point Injection (TPI)

ACTIVE COMPARATOR

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

Interventions

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

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.

Erector Spinae Plane (ESP) Block
Trigger Point Injection (TPI) with 0.5% Plain BupivacaineDRUG

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.

Trigger Point Injection (TPI)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Mayo Clinic

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

NOT YET RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Back Pain

Interventions

ParapsychologyDental Occlusion

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral SciencesBehavioral Disciplines and ActivitiesDentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Ryan D'Souza, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan D'Souza, MD

CONTACT

507-284-9696dsouza.ryan@mayo.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist, Pain Physician

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 8, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 30, 2029

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(5)