Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
| Ohio State University | OTHER |
| University of Maryland, Baltimore | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erector Spinae Plane (ESP) Block | Experimental | 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) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector Spinae Plane (ESP) Block with 0.5% Plain Bupivacaine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | baseline, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 6 weeks |
| Center for Epidemiologic Studies Depression Scale (CES-D) |
| Measure | Description | Time Frame |
|---|---|---|
| Fasciculation (in Trigger Point Injection Cohort Only) | 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) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan D'Souza, MD | Contact | 507-284-9696 | dsouza.ryan@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ryan D'Souza, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Not yet recruiting | Jacksonville | Florida | 32224 | United States |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Trigger Point Injection (TPI) with 0.5% Plain Bupivacaine | Drug | 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. |
|
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) | 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) | 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 | 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 | 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 |
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 | 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) |
| University of Maryland | Not yet recruiting | Baltimore | Maryland | 21201 | United States |
|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| The Ohio State University Wexner Medical Center | Not yet recruiting | Columbus | Ohio | 43210 | United States |
|
| MD Anderson Cancer Center | Not yet recruiting | Houston | Texas | 77030 | United States |
|
| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D010268 | Parapsychology |
| D003766 | Dental Occlusion |
| ID | Term |
|---|---|
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
Not provided
Not provided