Erector Spinae Plane Block Versus Trigger Point Injection for Chronic Thoracic Myofascial Pain
ConditionBack Pain
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMayo Clinic
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Thoracic radiculopathy
Cervical myelopathy with neurological deficit
Prior cervicothoracic spine surgery
Pregnancy or lactation
Trial design
Design model
Parallel
Treatments tested in this trial
Erector Spinae Plane (ESP) Block with 0.5% Plain Bupivacaine
DrugParticipants 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 Bupivacaine
DrugParticipants 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.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Erector Spinae Plane (ESP) BlockExperimental treatment 1 intervention
Group B: Trigger Point Injection (TPI)Active comparator 1 intervention
Trial outcomes
Primary outcomes
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".
Time frame
baseline, 6 weeksSecondary outcomes
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.
Time frame
baseline, 6 weeks2
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.
Time frame
baseline, 6 weeks3
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.
Time frame
baseline, 6 weeks4
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.
Time frame
6 weeksOther outcomes
1
Fasciculation (in Trigger Point Injection Cohort Only)
Proceduralist will document occurrence (yes/no) of muscle fasciculation while performing trigger point injection.
Time frame
Day 0 (procedure day)2
Taut band Visualization (in Trigger Point Injection Cohort Only)
The proceduralist will document ultrasound visualization of a taut band (yes/no) while performing trigger point injection only.
Time frame
Day 0 (procedure day)3
Numeric Rating Scale (NRS) Pain Score During and After Injection
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.
Time frame
Day 0 (procedure day)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
M.D. Anderson Cancer Center
Collaborator
Ohio State University
Collaborator
University of Maryland, Baltimore
Collaborator
Source ClinicalTrials.gov