NCT05700279 · Rush University Medical Center
Preventing the Development of Chronic Pain: Treating PTSD at Acute Pain Onset
What this study is about
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.
View original scientific description
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.
Interventions
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.
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.
Primary outcome measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 ED with acute pain without debilitating trauma
- A primary acute pain site
- Self-reported symptoms consistent with a diagnosis of PTSD
- 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
- 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
- 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)
- 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
- 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
- Any injury or illness that precludes their ability to understand or follow instructions as assessed by a member of the medical staff
- Self-reported history of chronic pain on presentation to the ED or documented in the electronic medical record (case-by-case basis)
- Pain from traumatic event that is the source of their PTSD
- Neurological disorder
- Blood pressure greater than 160/100 mmHg
- Taking anticoagulants or antiplatelet drugs other than aspirin
- Current alcohol or substance dependence
- Anything that precludes interventions from being successful.
- 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.
Where
- Chicago, Illinois
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 20, 2025 · Source of record for eligibility and locations