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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, for an average of 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 70 years old.
Select...
I am in the ER for a medical issue and am in acute pain not caused by an injury.
Select...
My main pain is in my chest, back, shoulder, abdomen, or pelvis.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in CAPS-5 PTSD Diagnosis
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 outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
422 Previous Clinical Trials
163,156 Total Patients Enrolled
7 Trials studying Chronic Pain
1,267 Patients Enrolled for Chronic Pain
United States Department of DefenseFED
865 Previous Clinical Trials
327,354 Total Patients Enrolled
11 Trials studying Chronic Pain
2,350 Patients Enrolled for Chronic Pain
John W Burns, PhDPrincipal InvestigatorRush University Medical Center
2 Previous Clinical Trials
981 Total Patients Enrolled
2 Trials studying Chronic Pain
981 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood pressure is higher than 160/100 mmHg.My pain is severe enough to affect my focus or understanding.I have been diagnosed with cancer.I frequently experience pain due to my current illness.You have ever had severe mental illness like schizophrenia or bipolar disorder.I experience symptoms that suggest I have PTSD.I am between 18 and 70 years old.I have a neurological disorder.I am taking blood thinners that are not aspirin.I can understand and follow instructions without any issues.I experience pain from the event that caused my PTSD.You are currently dependent on alcohol or drugs.I have a history of chronic pain noted in my medical records.I am being treated for a chronic disease but do not have chronic or neuropathic pain.I am in the ER for a medical issue and am in acute pain not caused by an injury.My main pain is in my chest, back, shoulder, abdomen, or pelvis.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Processing Therapy
- Group 2: Usual Care
- Group 3: Stellate Ganglion Block Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age of participants eligible for this research limited to those under 70 years old?
"This research protocol is seeking participants above the age of majority and under 70 years old."
Answered by AI
Am I eligible to partake in this clinical investigation?
"Qualified patients for this clinical trial must have chronic pain and be between 18 to 70 years old. The total number of eligible participants is 345."
Answered by AI
Are individuals still able to join this experiment?
"According to the information hosted on clinicaltrials.gov, this particular trial has ceased recruitment as of January 17th 2023; it was first posted two months prior on February 1st. Nevertheless, there are 823 other trials still actively seeking patients at this moment in time."
Answered by AI
What is the desired outcome of this research endeavor?
"This clinical trial aims to evaluate and measure the efficacy of a new treatment by assessing changes in PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5) Self-Reported PTSD Symptoms over an average period of 6 months. Secondary objectives include ascertaining modifications in Alcohol Use Disorder Identification Test (AUDIT-C), Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and Pain Interference scores reported by participants."
Answered by AI
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