What this study is
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.
What's being tested
- Stellate Ganglion Block
Intervention · PROCEDURE
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.
- Cognitive Processing Therapy
Intervention · BEHAVIORAL
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.
Study details
- Sponsor
- Rush University Medical Center
- Conditions
- PTSD · Chronic Pain
- Enrolling
- 345 people
- Starts
- 2023-09-01
- Est. completion
- 2027-02-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 70 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join if
- 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
- Pregnancy
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openRush University Medical Center
Chicago, Illinois, United States
- John W Burns, PhD · Contact312-942-0379john_burns@rush.edu
Recruiting
Study team
Sponsor
Rush University Medical Center
Study ID 21092002
Principal investigator
John W Burns, PhD
Rush University Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.