Clinical trial NCT05700279: 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
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Chronic Pain
Keywords: PTSD
Chronic Pain
Acute Pain
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-01-26
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

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 ED with acute pain without debilitating trauma
4. A primary acute pain site
5. Self-reported symptoms consistent with a diagnosis of PTSD
6. People with well-controlled diabetes or HIV/AIDS with chronic neuropathic pain will be included if their acute pain complaint at ED presentation is not due to neuropathic pain
7. Individuals with a history of psychotic or bipolar disorder that is currently well managed, have been treated for the condition for at least 3 months, are able to coherently answer interview questions, and are judged by study staff to be capable of participating in study
8. Current chronic illness that involves constant or frequent pain if their acute pain complaint at ED presentation is not due to the chronic illness. (case-by-case basis)
9. Current chronic pain from various sources if their acute pain complaint at ED presentation is not related to their current chronic pain. (case-by-case basis)

Exclusion Criteria:

1. Pain intensity great enough to impair concentration or capacity to understand instructions or the nature of being invited into a study as assessed by a member of the medical staff
2. Any injury or illness that precludes their ability to understand or follow instructions as assessed by a member of the medical staff
3. Self-reported history of chronic pain on presentation to the ED or documented in the electronic medical record (case-by-case basis)
4. Pain from traumatic event that is the source of their PTSD
5. Neurological disorder
6. Blood pressure greater than 160/100 mmHg
7. Taking anticoagulants or antiplatelet drugs other than aspirin
8. Pregnancy
9. Current alcohol or substance dependence
10. Anything that precludes interventions from being successful.
11. We will exclude people who are being treated for chronic or significant diseases such as rheumatoid disease, current influenza that may manifest temporary flu- related pain, and heart disease.

Primary outcomes:
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity
timeFrame: Through study completion, for an average of 6 months
measure: Change in PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5) Self-Reported PTSD Symptoms
timeFrame: Through study completion, for an average of 6 months
Secondary outcomes:
measure: Change in SCID-5 mood and anxiety disorder diagnoses
timeFrame: Through study completion, for an average of 6 months
measure: Change in AUDIT-C Self-Reported Substance Use
timeFrame: Through study completion, for an average of 6 months
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
timeFrame: Through study completion, for an average of 6 months
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (Short Form)
timeFrame: Through study completion, for an average of 6 months
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form)
timeFrame: Through study completion, for an average of 6 months
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance (short form)
timeFrame: Through study completion, for an average of 6 months
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety (short form)
timeFrame: Through study completion, for an average of 6 months
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) anger (short form)
timeFrame: Through study completion, for an average of 6 months
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles
timeFrame: Through study completion, for an average of 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: John W Burns, PhD
role: PRINCIPAL_INVESTIGATOR
References: