## Protocol Section
### Identification Module
**NCT ID:** NCT05700279

**Brief Title:** Preventing the Development of Chronic Pain: Treating PTSD at Acute Pain Onset

**Official Title:** Preventing the Development of Chronic Pain: Treating PTSD at Acute Pain Onset

#### Organization Study ID Info
**ID:** 21092002
#### Organization
**Class:** OTHER
**Full Name:** Rush University Medical Center
### Status Module
#### Completion Date
**Date:** 2027-02-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-10

**Type:** ACTUAL

**Last Update Submit Date:** 2023-10-06

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-02-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-09-01

**Type:** ACTUAL

**Status Verified Date:** 2023-10

#### Study First Post Date
**Date:** 2023-01-26
**Type:** ACTUAL
**Study First Submit Date:** 2023-01-17
**Study First Submit QC Date:** 2023-01-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** FED

**Name:** United States Department of Defense

#### Lead Sponsor

**Class:** OTHER

**Name:** Rush University Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** 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.

**Detailed Description:** 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 Emergency Department (ED) 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), and 112 (approximately 6 months after ED presentation).

### Conditions Module

**Conditions:**

- PTSD

- Chronic Pain

**Keywords:**

- PTSD

- Chronic Pain

- Acute Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 345

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants randomly assigned to the Stellate Ganglion Block (SGB) condition will receive 2 SGB treatments separated by 2 weeks.

**Intervention Names:**

- Procedure: Stellate Ganglion Block

**Label:** Stellate Ganglion Block Treatment

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Behavioral: Cognitive Processing Therapy

**Label:** Cognitive Processing Therapy

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Participants randomly assigned to the Usual Care condition will not receive any active intervention.

**Label:** Usual Care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Stellate Ganglion Block Treatment

**Description:** 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.

**Name:** Stellate Ganglion Block

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Cognitive Processing Therapy

**Description:** 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.

**Name:** Cognitive Processing Therapy

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity

**Time Frame:** Through study completion, for an average of 6 months

**Description:** 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.

**Measure:** Change in PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5) Self-Reported PTSD Symptoms

**Time Frame:** Through study completion, for an average of 6 months

**Description:** Clinician Administered PTSD Scale for DSM-5 (CAPS-5) will be administered by a trained interviewer for formal assessment for PTSD diagnosis. The CAPS-5 is a semi-structured interview measure consisting of 30 items. Interviewers assess the frequency and intensity of PTSD symptoms; These frequency and severity scores for each item are then combined into one symptom severity score for each item that ranges from "absent" (0) to "extreme/incapacitating" (4). Higher scores indicate greater PTSD symptom severity.

**Measure:** Change in CAPS-5 PTSD Diagnosis

**Time Frame:** Through study completion, for an average of 6 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Change in SCID-5 mood and anxiety disorder diagnoses

**Time Frame:** Through study completion, for an average of 6 months

**Description:** 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).

**Measure:** Change in AUDIT-C Self-Reported Substance Use

**Time Frame:** Through study completion, for an average of 6 months

**Description:** 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.

**Measure:** Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

**Time Frame:** Through study completion, for an average of 6 months

**Description:** 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.

**Measure:** Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (Short Form)

**Time Frame:** Through study completion, for an average of 6 months

**Description:** 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.

**Measure:** Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form)

**Time Frame:** Through study completion, for an average of 6 months

**Description:** 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.

**Measure:** Change in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance (short form)

**Time Frame:** Through study completion, for an average of 6 months

**Description:** 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.

**Measure:** Change in Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety (short form)

**Time Frame:** Through study completion, for an average of 6 months

**Description:** 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.

**Measure:** Change in Patient-Reported Outcomes Measurement Information System (PROMIS) anger (short form)

**Time Frame:** Through study completion, for an average of 6 months

**Description:** 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.

**Measure:** Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles

**Time Frame:** Through study completion, for an average of 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Age 18 to 70 years
2. Ability to read and write English sufficiently to understand and complete study questionnaires and participate in interviews
3. Presenting to the Rush Emergency Department (ED) with a medical problem and experiencing non-injury based acute pain
4. A primary acute pain site of chest, back, shoulder, abdomen, or pelvis
5. Self-reported symptoms consistent with a diagnosis of PTSD

Exclusion Criteria:

1. Pain intensity great enough to impair concentration or capacity to understand instructions or nature of being invited into a study, as assessed by a member of medical staff
2. Any illness or injury that precludes the ability to understand or follow instructions, as assessed by a member of the medical staff
3. Current illness that involves constant or frequent pain
4. Self-reported history of chronic pain on presentation to the ED or documented in the electronic medical record
5. Pain from the traumatic event that is the source of their PTSD
6. Neurological disorder
7. Cancer diagnosis
8. Blood pressure greater than 160/100 mmHg
9. Taking anticoagulants or antiplatelet drugs other than aspirin
10. Pregnancy
11. Current or lifetime psychotic or bipolar disorders
12. Current alcohol or substance dependence
13. Receiving treatment for chronic or significant disease such rheumatoid disease, current influenza that may manifest temporary flu-related pain, and heart disease. People with well-controlled diabetes or HIV/AIDS will be included only if there is no self-reported history of chronic or neuropathic pain on presentation to the ED or documented in the electronic medical record.

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** john_burns@rush.edu

**Name:** John W Burns, PhD

**Phone:** 312-942-0379

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Email:** john_burns@rush.edu

- **Name:** John W Burns, PhD

- **Phone:** 312-942-0379

- **Role:** CONTACT

**Country:** United States

**Facility:** Rush University Medical Center

**State:** Illinois

**Status:** RECRUITING

**Zip:** 60612

#### Overall Officials

**Official 1:**

**Affiliation:** Rush University Medical Center

**Name:** John W Burns, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2023-04-25

- Filename: ICF_000.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 341129

- Type Abbrev: ICF

- Upload Date: 2023-06-19T16:55

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M29442

- Name: Chronic Pain

- Relevance: HIGH

- As Found: Chronic Pain

- ID: M29525

- Name: Acute Pain

- Relevance: HIGH

- As Found: Acute Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: HIGH

- As Found: Chronic

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000059350

- Term: Chronic Pain

- ID: D000059787

- Term: Acute Pain

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1700

- Name: Ropivacaine

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
