Erector Spinae Plane Block Versus Trigger Point Injection for Chronic Thoracic Myofascial Pain
4 september 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
76
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Ryan D'Souza, MD
- Telefonnummer: 507-284-9696
- E-post: dsouza.ryan@mayo.edu
Studieorter
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Florida
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Jacksonville, Florida, Förenta staterna, 32224
- Har inte rekryterat ännu
- Mayo Clinic
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Kontakt:
- Eva Kubrova, MD
- Telefonnummer: 904-956-2043
- E-post: kubrova.eva@mayo.edu
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Huvudutredare:
- Eva Kubrova, MD
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Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- Har inte rekryterat ännu
- University of Maryland
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Kontakt:
- Jay Karri, MD
- Telefonnummer: 410-706-3100
- E-post: jkarri@som.umaryland.edu
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Huvudutredare:
- Jay Karri, MD
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Rekrytering
- Mayo Clinic
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Huvudutredare:
- Ryan D'Souza, MD
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Kontakt:
- Ryan D'Souza, MD
- Telefonnummer: 507-284-9696
- E-post: dsouza.ryan@mayo.edu
-
-
Ohio
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Columbus, Ohio, Förenta staterna, 43210
- Har inte rekryterat ännu
- The Ohio State University Wexner Medical Center
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Kontakt:
- Nasir Hussain, MD
- Telefonnummer: 614-293-8000
- E-post: nasir.hussain@osumc.edu
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Huvudutredare:
- Nasir Hussain, MD
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Texas
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Houston, Texas, Förenta staterna, 77030
- Har inte rekryterat ännu
- MD Anderson Cancer Center
-
Huvudutredare:
- Saba Javed, MD
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Kontakt:
- Saba Javed, MD
- Telefonnummer: 877-632-6789
- E-post: sjaved@mdanderson.org
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Numeric Rating Scale (NRS) Pain Score
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Modified Oswestry Disability Index
Tidsram: 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
|
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Center for Epidemiologic Studies Depression Scale (CES-D)
Tidsram: 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.
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baseline, 6 weeks
|
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Pain Catastrophizing Scale (PCS)
Tidsram: 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.
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baseline, 6 weeks
|
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Patient Global Impression of Change (PGIC)
Tidsram: 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.
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6 weeks
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Repeat Injections
Tidsram: 12 weeks
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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).
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12 weeks
|
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Adverse Events
Tidsram: Day 0 (procedure day), 6 weeks
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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.
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Day 0 (procedure day), 6 weeks
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Fasciculation (in Trigger Point Injection Cohort Only)
Tidsram: Day 0 (procedure day)
|
Proceduralist will document occurrence (yes/no) of muscle fasciculation while performing trigger point injection.
|
Day 0 (procedure day)
|
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Taut band Visualization (in Trigger Point Injection Cohort Only)
Tidsram: 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)
|
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Numeric Rating Scale (NRS) Pain Score During and After Injection
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Ryan D'Souza, MD, Mayo Clinic
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
13 augusti 2026
Primärt slutförande (Beräknad)
1 augusti 2029
Avslutad studie (Beräknad)
30 augusti 2029
Studieregistreringsdatum
Först inskickad
3 juni 2026
Först inskickad som uppfyllde QC-kriterierna
3 juni 2026
Första postat (Faktisk)
8 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 26-004708
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