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

Primary Purpose

PTSD, Chronic Pain

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stellate Ganglion Block

Cognitive Processing Therapy

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Chronic Pain, Acute Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 to 70 years Ability to read and write English sufficiently to understand and complete study questionnaires and participate in interviews Presenting to the Rush Emergency Department (ED) with a medical problem and experiencing non-injury based acute pain A primary acute pain site of chest, back, shoulder, abdomen, or pelvis Self-reported symptoms consistent with a diagnosis of PTSD Exclusion Criteria: 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 Any illness or injury that precludes the ability to understand or follow instructions, as assessed by a member of the medical staff Current illness that involves constant or frequent pain Self-reported history of chronic pain on presentation to the ED or documented in the electronic medical record Pain from the traumatic event that is the source of their PTSD Neurological disorder Cancer diagnosis Blood pressure greater than 160/100 mmHg Taking anticoagulants or antiplatelet drugs other than aspirin Pregnancy Current or lifetime psychotic or bipolar disorders Current alcohol or substance dependence 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.

Sites / Locations

Rush University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Stellate Ganglion Block Treatment

Cognitive Processing Therapy

Usual Care

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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.

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.

Change in CAPS-5 PTSD Diagnosis

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.

Secondary Outcome Measures

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.

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).

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT05700279

First Posted

January 17, 2023

Last Updated

October 6, 2023

Sponsor

Rush University Medical Center

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2023 (Actual)

Primary Completion Date

February 1, 2027 (Anticipated)

Study Completion Date

February 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rush University Medical Center

Collaborators

United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PTSD, Chronic Pain

Keywords

PTSD, Chronic Pain, Acute Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

345 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stellate Ganglion Block Treatment

Arm Type

Active Comparator

Arm Description

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

Arm Title

Cognitive Processing Therapy

Arm Type

Active Comparator

Arm Description

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Stellate Ganglion Block

Intervention 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.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Processing Therapy

Intervention 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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame