Rush University Medical Center
Chicago, Illinois, 60612, United States
Location status: Recruiting
NCT Number: NCT05700279
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60612, United States
Location status: Recruiting
Untreated PTSD appears to be a key risk factor for the transition from acute pain to chronic pain. Thus, reducing PTSD symptoms during an acute pain episode may potentially decrease the likelihood of transitioning to chronic pain. CPT is an evidence-based trauma-focused cognitive behavioral treatment that is hypothesized to reduce PTSD symptoms via reducing negative trauma-related cognitions about oneself, others, and the world. SGB treatment is an injection of a local anesthetic into the stellate ganglion, which is a bundle of nerves located at the base of the neck that is part of the sympathetic nervous system. Previous studies suggest that 1-week massed CPT and SGB treatment can both reduce the severity of PTSD symptoms in short periods of time via two distinct psychological and biological mechanisms.
This 4 year project will test study hypotheses in a sample of 345 individuals with PTSD symptoms who present to the presenting to the Rush University Medical Center ED or Rush's Primary Care and Preventive Medicine group with non-injury based acute pain. Participants will be randomly assigned to receive 1-week massed CPT, 2 SGB treatments, or usual care. All participants will complete identical self-report and/or clinician administered assessments at baseline (prior to randomization) and on study days 1, 7, 14, 21, 28, 56 (approximately 3 months after the initial ED presentation or Presentation to Preventive Medicine), and 112 (approximately 6 months after ED presentation or presentation to Preventive Medicine).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 (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.
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.
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.
Time frame: Through study completion, for an average of 6 months
The Structured Clinical Interview for the DSM-5 (SCID-5) is a semi-structured interview measure for making DSM-5 diagnoses. The SCID-5 will be administered by a trained interviewer for assessment of mood and anxiety disorders.
Time frame: Through study completion, for an average of 6 months
The Alcohol Use Disorder Identification Test (AUDIT-C) is a self-report questionnaire consisting of 12 items that ask participants about the frequency of their alcohol and substance use both generally and within the past 2 weeks (14 calendar days).
Time frame: Through study completion, for an average of 6 months
Interference in daily activities attributed to chronic pain as reported by subjects. The PROMIS Pain Interference scale consists of 8 questions with a 5-point response scale ranging from "Not at all" to "Very much." Participants are asked how much in the past 7 days everyday activities were affected by their pain. Higher scores indicate more pain interference in daily activities.
Time frame: Through study completion, for an average of 6 months
Degree of depressive symptoms reported by subject. The PROMIS Depression scale consists of 8 questions with a 5-point response scale ranging from "Never" to "Always." Participants are asked how often they felt depressive emotions in the past 7 days. Higher scores indicate more depressive emotions.
Time frame: Through study completion, for an average of 6 months
Amount of physical activity reported by subject. The PROMIS Physical Function scale consists of 10 questions with a 5-point response scale ranging from "Without any difficulty" to "Unable to do." Participants are asked how much their pain affects their physical functioning. Higher scores indicate more inability to perform specific physical activities due to pain.
Time frame: Through study completion, for an average of 6 months
Degree of sleep disturbance reported by subject. The PROMIS Sleep Disturbance scale consists of 8 questions with a 5-point response scale ranging from "Not at all" to "Very much." Participants are asked how much in the past 7 days their symptoms interfered with their sleep. Higher scores indicate more sleep disruptions.
Time frame: Through study completion, for an average of 6 months
Degree of anxiety symptoms reported by subject. The PROMIS Anxiety scale consists of 7 questions with a 5-point response scale ranging from "Never" to "Always." Participants are asked how often they experienced anxiety symptoms in the past 7 days. Higher scores indicate more anxiety symptoms.
Time frame: Through study completion, for an average of 6 months
Degree of anger reported by subject. The PROMIS Anger scale consists of 5 questions with a 5-point response scale ranging from "Never" to "Always." Participants are asked how often they experienced anger in the past 7 days. Higher scores indicate more frequent anger.
Time frame: Through study completion, for an average of 6 months
Satisfaction with social roles reported by subject. The PROMIS Satisfaction with Social Roles scale consists of 7 questions with a 5-point response scale ranging from "Not at all" to "Very Much." Participants are asked how satisfied they have felt with their performance in various social roles in the past 7 days. Higher scores indicate greater satisfaction.
Contact information is provided by the study sponsor or research team.
Rush University Medical Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07225049
Chronic Pain, Mental Disorders
New York, United States
View Trial DetailsNCT05147948
Chronic Pain, Mental Disorders
Lund, Sweden
View Trial DetailsNCT04512755
Chronic Disease, Chronic Pain
Seattle, Washington, United States
View Trial DetailsNCT07482358
Anxiety Disorders, Behavior
Centennial, Colorado, United States
View Trial Details