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Recruiting NCT07632820

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

Phase IV Interventional Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Erector Spinae Plane (ESP) Block with 0.5% Plain Bupivacaine, Trigger Point Injection (TPI) with 0.5% Plain Bupivacaine.
Who it may be relevant to
Registry conditions: Back Pain. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Numeric Rating Scale (NRS) Pain Score [Time frame: baseline, 6 weeks]
Secondary outcome measures (6)
  • Modified Oswestry Disability Index [Time frame: baseline, 6 weeks]
  • Center for Epidemiologic Studies Depression Scale (CES-D) [Time frame: baseline, 6 weeks]
  • Pain Catastrophizing Scale (PCS) [Time frame: baseline, 6 weeks]
  • Patient Global Impression of Change (PGIC) [Time frame: 6 weeks]
  • Repeat Injections [Time frame: 12 weeks]
  • Adverse Events [Time frame: Day 0 (procedure day), 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Mayo Clinic — Jacksonville
  • University of Maryland — Baltimore
  • Mayo Clinic — Rochester
  • The Ohio State University Wexner Medical Center — Columbus
  • MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT07632820 · 26-004708

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗