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

• ClinicalTrials.gov Identifier: NCT05700279
• Recruitment Status: Recruiting
• First Posted: January 26, 2023
• Last Update Posted: October 10, 2023
• Sponsor: Rush University Medical Center
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): Rush University Medical Center

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.

Condition or disease	Intervention/treatment	Phase
PTSD; Chronic Pain	Procedure: Stellate Ganglion Block; Behavioral: Cognitive Processing Therapy	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 345 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Preventing the Development of Chronic Pain: Treating PTSD at Acute Pain Onset
• Actual Study Start Date: September 1, 2023
• Estimated Primary Completion Date: February 1, 2027
• Estimated Study Completion Date: February 1, 2027

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Stellate Ganglion Block Treatment; Participants randomly assigned to the Stellate Ganglion Block (SGB) condition will receive 2 SGB treatments separated by 2 weeks.	Procedure: Stellate Ganglion Block; 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.
Active Comparator: Cognitive Processing Therapy; 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.	Behavioral: Cognitive Processing Therapy; 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.
No Intervention: Usual Care; Participants randomly assigned to the Usual Care condition will not receive any active intervention.

Outcome Measures

Primary Outcome Measures :

1. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity [ Time Frame: Through study completion, for an average of 6 months ]
   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.
2. 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 ]
   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.
3. Change in CAPS-5 PTSD Diagnosis [ Time Frame: Through study completion, for an average of 6 months ]
   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 :

1. Change in SCID-5 mood and anxiety disorder diagnoses [ Time Frame: Through study completion, for an average of 6 months ]
   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.
2. Change in AUDIT-C Self-Reported Substance Use [ Time Frame: Through study completion, for an average of 6 months ]
   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).
3. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference [ Time Frame: Through study completion, for an average of 6 months ]
   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.
4. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (Short Form) [ Time Frame: Through study completion, for an average of 6 months ]
   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.
5. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form) [ Time Frame: Through study completion, for an average of 6 months ]
   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.
6. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance (short form) [ Time Frame: Through study completion, for an average of 6 months ]
   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.
7. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety (short form) [ Time Frame: Through study completion, for an average of 6 months ]
   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.
8. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) anger (short form) [ Time Frame: Through study completion, for an average of 6 months ]
   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.
9. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles [ Time Frame: Through study completion, for an average of 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: John W Burns, PhD; 312-942-0379; john_burns@rush.edu

Locations

United States, Illinois

Rush University Medical Center; Recruiting

Chicago, Illinois, United States, 60612

Contact: John W Burns, PhD 312-942-0379 john_burns@rush.edu

Sponsors and Collaborators

Rush University Medical Center

United States Department of Defense

Investigators

• Principal Investigator: John W Burns, PhD; Rush University Medical Center

  Study Documents (Full-Text)

Documents provided by Rush University Medical Center:

Informed Consent Form  [PDF] April 25, 2023

More Information

• Responsible Party: Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT05700279
• Other Study ID Numbers: 21092002
• First Posted: January 26, 2023
• Last Update Posted: October 10, 2023
• Last Verified: October 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rush University Medical Center:

PTSD; Chronic Pain; Acute Pain

Additional relevant MeSH terms:

Chronic Pain; Acute Pain; Pain; Neurologic Manifestations