AzTrials
AzTrials

Back PainPhase 4NCT07632820

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

A Phase 4 study testing Erector Spinae Plane (ESP) Block with 0.5% Plain Bupivacaine and Trigger Point Injection (TPI) with 0.5% Plain Bupivacaine in people with Back Pain, run by Mayo Clinic at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Back Pain
What is being tested?
Erector Spinae Plane (ESP) Block with 0.5% Plain Bupivacaine and Trigger Point Injection (TPI) with 0.5% Plain Bupivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
5 sitesUnited States
Study dates
13 Aug 2026to 30 Aug 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Thoracic radiculopathy
  • Cervical myelopathy with neurological deficit
  • Prior cervicothoracic spine surgery
  • Pregnancy or lactation
  • Contraindication to local anesthetic
  • Active malignancy
Show all 14Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ryan D'Souza, MD contact

507-284-9696

dsouza.ryan@mayo.edu

5 sites in 1 country

United States5 sites, 5 recruiting

  • University of Maryland

    Baltimore, Maryland, 21201

    Jay Karri, MD, 410-706-3100, jkarri@som.umaryland.edu

    Jay Karri, MD

    Not yet recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Nasir Hussain, MD, 614-293-8000, nasir.hussain@osumc.edu

    Nasir Hussain, MD

    Not yet recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Saba Javed, MD, 877-632-6789, sjaved@mdanderson.org

    Saba Javed, MD

    Not yet recruiting

  • Mayo Clinic

    Jacksonville, Florida, 32224

    Eva Kubrova, MD, 904-956-2043, kubrova.eva@mayo.edu

    Eva Kubrova, MD

    Not yet recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

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

    Ryan D'Souza, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Conditions
Back Pain
Being tested
Erector Spinae Plane (ESP) Block with 0.5% Plain Bupivacaine, Trigger Point Injection (TPI) with 0.5% Plain Bupivacaine
Keywords
thoracic back pain, myofascial pain, thoracic myofascial pain, Trigger point injection, Erector spinae plane block, TPI, ESP block
Medical subject headings
Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erector Spinae Plane (ESP) Block with 0.5% Plain BupivacaineDrug

    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.

  • Trigger Point Injection (TPI) with 0.5% Plain BupivacaineDrug

    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.

Study groups in NCT07632820
Study groupRoleWhat they receive
Erector Spinae Plane (ESP) BlockExperimentalParticipants 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.
Receives: Drug: Erector Spinae Plane (ESP) Block with 0.5% Plain Bupivacaine
Trigger Point Injection (TPI)Active comparatorParticipants 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.
Receives: Drug: Trigger Point Injection (TPI) with 0.5% Plain Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric Rating Scale (NRS) Pain Score

    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".

    Measured: baseline, 6 weeks

Secondary outcomes (6)

  1. Modified Oswestry Disability Index

    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.

    Measured: baseline, 6 weeks

  2. Center for Epidemiologic Studies Depression Scale (CES-D)

    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.

    Measured: baseline, 6 weeks

  3. Pain Catastrophizing Scale (PCS)

    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.

    Measured: baseline, 6 weeks

  4. Patient Global Impression of Change (PGIC)

    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.

    Measured: 6 weeks

  5. Repeat Injections

    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).

    Measured: 12 weeks

  6. Adverse Events

    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.

    Measured: Day 0 (procedure day), 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2026
  2. Study start13 Aug 2026
  3. Primary completion1 Aug 2029 (estimated)
  4. Study completion30 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07632820
Sponsor's protocol ID
26-004708
Status last verified
Sep 2026
First submitted
3 Jun 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Erector Spinae Plane (ESP) Block with 0.5% Plain Bupivacaine and Trigger Point Injection (TPI) with 0.5% Plain Bupivacaine in people with Back Pain, run by Mayo Clinic at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ryan D'Souza, MD (507-284-9696, dsouza.ryan@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Rating Scale (NRS) Pain Score (time frame: baseline, 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07632820.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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