Preventing the Development of Chronic Pain: Treating PTSD at Acute Pain Onset
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Rush University Medical Center
- Study ID
- NCT05700279
- Status
- Recruiting
Conditions
- Chronic Pain
- PTSD
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Stellate Ganglion Block — PROCEDUREStellate 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.
- Cognitive Processing Therapy — BEHAVIORALCognitive 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.
Study Details
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.
Key Dates
- Start date
- Sep 1, 2023
- Status verified
- Oct 2025
- Primary completion
- Feb 1, 2027
- Completion
- Feb 1, 2027
Study Design
- Enrollment
- 345 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Stellate Ganglion Block TreatmentParticipants randomly assigned to the Stellate Ganglion Block (SGB) condition will receive 2 SGB treatments separated by 2 weeks.
- Active Comparator: Cognitive Processing TherapyParticipants 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.
- No Intervention: Usual CareParticipants randomly assigned to the Usual Care condition will not receive any active intervention.
Primary Outcome Measure
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity [ Time Frame: Through study completion, for an average of 6 months ]
Central Contacts
- John W Burns, PhD312-942-0379
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 |
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