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PTSD Treatment for Preventing Chronic Pain

N/A

Recruiting

Led By John W Burns, PhD

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 70 years

Presenting to the Rush Emergency Department (ED) with a medical problem and experiencing non-injury based acute pain

Must not have

Current illness that involves constant or frequent pain

Neurological disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, for an average of 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at how reducing PTSD symptoms can help people prevent acute pain from becoming chronic.

Who is the study for?

This trial is for adults aged 18-70 who speak English, have acute pain in the chest, back, shoulder, abdomen or pelvis without injury and show PTSD symptoms. They must not have chronic pain conditions, neurological disorders, high blood pressure over 160/100 mmHg, be on certain blood thinners (except aspirin), pregnant or impaired by pain to follow instructions.

What is being tested?

The study tests if Stellate Ganglion Block (SGB) treatment or Cognitive Processing Therapy (CPT) can reduce PTSD symptoms and prevent acute non-injury based pain from becoming chronic. Participants will receive one of these treatments to see if it helps with their PTSD and stops acute pain from lasting long-term.

What are the potential side effects?

Possible side effects are not detailed here but may include discomfort at injection site for SGB treatment and emotional distress during CPT as patients confront traumatic memories. The specific risks associated with each intervention would be explained before consent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I am in the ER for a medical issue and am in acute pain not caused by an injury.

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My main pain is in my chest, back, shoulder, abdomen, or pelvis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I frequently experience pain due to my current illness.

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I have a neurological disorder.

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I am taking blood thinners that are not aspirin.

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I experience pain from the event that caused my PTSD.

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I have a history of chronic pain noted in my medical records.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, for an average of 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, for an average of 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, for an average of 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

Change in AUDIT-C Self-Reported Substance Use

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

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

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Cognitive Processing TherapyActive Control1 Intervention

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.

Group II: Usual CareActive Control1 Intervention

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

Group III: Stellate Ganglion Block TreatmentActive Control1 Intervention

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

0 / 8Eligibility criteria met