Back Pain
Conditions
Keywords
thoracic back pain, myofascial pain, thoracic myofascial pain, Trigger point injection, Erector spinae plane block, TPI, ESP block
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.
Interventions
DRUGErector 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.
DRUGTrigger 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.
Sponsors
Mayo Clinic
M.D. Anderson Cancer Center
Ohio State University
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) Pain Score | 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". |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Oswestry Disability Index | 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. |
| Center for Epidemiologic Studies Depression Scale (CES-D) | 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. |
| Pain Catastrophizing Scale (PCS) | 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. |
| Patient Global Impression of Change (PGIC) | 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. |
| Repeat Injections | 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). |
| Adverse Events | 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. |
Countries
United States
Contacts
CONTACTRyan D'Souza, MD
PRINCIPAL_INVESTIGATORRyan D'Souza, MD
Mayo Clinic
Outcome results
None listed