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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Ryan D'Souza, MD
507-284-9696
dsouza.ryan@mayo.edu

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Ryan D'Souza, MD
507-284-9696
dsouza.ryan@mayo.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.