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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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Although most people recover from acute pain (such as pain caused by injury, surgery, repetitive motion, or unknown causes), many people do not fully recover and will experience chronic pain. Untreated posttraumatic stress disorder (PTSD) appears to be a key risk factor for the transition from acute pain to chronic pain. However, few published studies have addressed the issue of preventing the transition from acute to chronic pain via PTSD reduction. This project will aim to test whether trauma-related PTSD symptoms can be reduced using either Stellate Ganglion Block (SGB) treatment or Cognitive Processing Therapy (CPT), and whether reducing PTSD symptoms can prevent the transition from non-injury based acute pain to chronic pain.
Untreated PTSD appears to be a key risk factor for the transition from acute pain to chronic pain. Thus, reducing PTSD symptoms during an acute pain episode may potentially decrease the likelihood of transitioning to chronic pain. CPT is an evidence-based trauma-focused cognitive behavioral treatment that is hypothesized to reduce PTSD symptoms via reducing negative trauma-related cognitions about oneself, others, and the world. SGB treatment is an injection of a local anesthetic into the stellate ganglion, which is a bundle of nerves located at the base of the neck that is part of the sympathetic nervous system. Previous studies suggest that 1-week massed CPT and SGB treatment can both reduce the severity of PTSD symptoms in short periods of time via two distinct psychological and biological mechanisms.
This 4 year project will test study hypotheses in a sample of 345 individuals with PTSD symptoms who present to the presenting to the Rush University Medical Center ED or Rush's Primary Care and Preventive Medicine group with non-injury based acute pain. Participants will be randomly assigned to receive 1-week massed CPT, 2 SGB treatments, or usual care. All participants will complete identical self-report and/or clinician administered assessments at baseline (prior to randomization) and on study days 1, 7, 14, 21, 28, 56 (approximately 3 months after the initial ED presentation or Presentation to Preventive Medicine), and 112 (approximately 6 months after ED presentation or presentation to Preventive Medicine).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stellate Ganglion Block Treatment | Active Comparator | Participants randomly assigned to the Stellate Ganglion Block (SGB) condition will receive 2 SGB treatments separated by 2 weeks. |
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| Cognitive Processing Therapy | Active Comparator | Participants randomly assigned to the Cognitive Processing Therapy (CPT) condition will receive 1-week massed CPT treatment consisting of 10 CPT sessions given within a single 5-day period via telehealth. |
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| Usual Care | No Intervention | Participants randomly assigned to the Usual Care condition will not receive any active intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stellate Ganglion Block | Procedure | Stellate Ganglion Block (SGB) procedure involves an injection of a local anesthetic (0.5% ropivacaine) around the stellate ganglion (a bundle of nerves located at the base of the neck) to block the transmission of pain signals. The SGB injection is administered by an anesthesiologist. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity | Intensity of chronic pain reported by subject. The PROMIS Pain Intensity scale consists of 3 questions with a 5-point response scale ranging from "Had no pain" -to "Very severe. " Participants are asked how intense their pain has been in the past 7 days. Higher scores indicate more intense pain. | Through study completion, for an average of 6 months |
| Change in PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5) Self-Reported PTSD Symptoms | PCL-5 will be used to measure self-reported PTSD symptoms. The PCL-5 consists of 20 questions that ask how much a given symptom has bothered the participant within a specified time period. Each question has a 5 point response scale ranging from "not at all" (0) to "extremely" (4). Higher scores indicate greater PTSD symptom severity. | Through study completion, for an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SCID-5 mood and anxiety disorder diagnoses | The Structured Clinical Interview for the DSM-5 (SCID-5) is a semi-structured interview measure for making DSM-5 diagnoses. The SCID-5 will be administered by a trained interviewer for assessment of mood and anxiety disorders. | Through study completion, for an average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John W Burns, PhD | Contact | 312-942-0379 | john_burns@rush.edu |
| Name | Affiliation | Role |
|---|---|---|
| John W Burns, PhD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 3, 2024 | Sep 3, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D059350 | Chronic Pain |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
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| Cognitive Processing Therapy | Behavioral | Cognitive Processing Therapy (CPT) is a form of trauma-based talk therapy that will be conducted by clinical therapists. CPT can help people identify and challenge unhelpful trauma-related beliefs about themselves, others, and the world. |
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| Change in AUDIT-C Self-Reported Substance Use |
The Alcohol Use Disorder Identification Test (AUDIT-C) is a self-report questionnaire consisting of 12 items that ask participants about the frequency of their alcohol and substance use both generally and within the past 2 weeks (14 calendar days). |
| Through study completion, for an average of 6 months |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference | Interference in daily activities attributed to chronic pain as reported by subjects. The PROMIS Pain Interference scale consists of 8 questions with a 5-point response scale ranging from "Not at all" to "Very much." Participants are asked how much in the past 7 days everyday activities were affected by their pain. Higher scores indicate more pain interference in daily activities. | Through study completion, for an average of 6 months |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (Short Form) | Degree of depressive symptoms reported by subject. The PROMIS Depression scale consists of 8 questions with a 5-point response scale ranging from "Never" to "Always." Participants are asked how often they felt depressive emotions in the past 7 days. Higher scores indicate more depressive emotions. | Through study completion, for an average of 6 months |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form) | Amount of physical activity reported by subject. The PROMIS Physical Function scale consists of 10 questions with a 5-point response scale ranging from "Without any difficulty" to "Unable to do." Participants are asked how much their pain affects their physical functioning. Higher scores indicate more inability to perform specific physical activities due to pain. | Through study completion, for an average of 6 months |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance (short form) | Degree of sleep disturbance reported by subject. The PROMIS Sleep Disturbance scale consists of 8 questions with a 5-point response scale ranging from "Not at all" to "Very much." Participants are asked how much in the past 7 days their symptoms interfered with their sleep. Higher scores indicate more sleep disruptions. | Through study completion, for an average of 6 months |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety (short form) | Degree of anxiety symptoms reported by subject. The PROMIS Anxiety scale consists of 7 questions with a 5-point response scale ranging from "Never" to "Always." Participants are asked how often they experienced anxiety symptoms in the past 7 days. Higher scores indicate more anxiety symptoms. | Through study completion, for an average of 6 months |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) anger (short form) | Degree of anger reported by subject. The PROMIS Anger scale consists of 5 questions with a 5-point response scale ranging from "Never" to "Always." Participants are asked how often they experienced anger in the past 7 days. Higher scores indicate more frequent anger. | Through study completion, for an average of 6 months |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles | Satisfaction with social roles reported by subject. The PROMIS Satisfaction with Social Roles scale consists of 7 questions with a 5-point response scale ranging from "Not at all" to "Very Much." Participants are asked how satisfied they have felt with their performance in various social roles in the past 7 days. Higher scores indicate greater satisfaction. | Through study completion, for an average of 6 months |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |