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

4. september 2026 oppdatert av: Ryan S. D'Souza, Mayo Clinic

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

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

76

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Florida
      • Jacksonville, Florida, Forente stater, 32224
        • Har ikke rekruttert ennå
        • Mayo Clinic
        • Ta kontakt med:
        • Hovedetterforsker:
          • Eva Kubrova, MD
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201
        • Har ikke rekruttert ennå
        • University of Maryland
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jay Karri, MD
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Rekruttering
        • Mayo Clinic
        • Hovedetterforsker:
          • Ryan D'Souza, MD
        • Ta kontakt med:
    • Ohio
      • Columbus, Ohio, Forente stater, 43210
        • Har ikke rekruttert ennå
        • The Ohio State University Wexner Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Nasir Hussain, MD
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Har ikke rekruttert ennå
        • MD Anderson Cancer Center
        • Hovedetterforsker:
          • Saba Javed, MD
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.
Aktiv komparator: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Numeric Rating Scale (NRS) Pain Score
Tidsramme: 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".
baseline, 6 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Modified Oswestry Disability Index
Tidsramme: 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.
baseline, 6 weeks
Center for Epidemiologic Studies Depression Scale (CES-D)
Tidsramme: 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.
baseline, 6 weeks
Pain Catastrophizing Scale (PCS)
Tidsramme: 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.
baseline, 6 weeks
Patient Global Impression of Change (PGIC)
Tidsramme: 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.
6 weeks
Repeat Injections
Tidsramme: 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).
12 weeks
Adverse Events
Tidsramme: 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.
Day 0 (procedure day), 6 weeks

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fasciculation (in Trigger Point Injection Cohort Only)
Tidsramme: Day 0 (procedure day)
Proceduralist will document occurrence (yes/no) of muscle fasciculation while performing trigger point injection.
Day 0 (procedure day)
Taut band Visualization (in Trigger Point Injection Cohort Only)
Tidsramme: Day 0 (procedure day)
The proceduralist will document ultrasound visualization of a taut band (yes/no) while performing trigger point injection only.
Day 0 (procedure day)
Numeric Rating Scale (NRS) Pain Score During and After Injection
Tidsramme: 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.
Day 0 (procedure day)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mayo Clinic

Samarbeidspartnere

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

Etterforskere

  • Hovedetterforsker: Ryan D'Souza, MD, Mayo Clinic

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. august 2026

Primær fullføring (Antatt)

1. august 2029

Studiet fullført (Antatt)

30. august 2029

Datoer for studieregistrering

Først innsendt

3. juni 2026

Først innsendt som oppfylte QC-kriteriene

3. juni 2026

Først lagt ut (Faktiske)

8. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 26-004708

Plan for individuelle deltakerdata (IPD)

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NEI

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Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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