PTSD Treatment for Preventing Chronic Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Rush University Medical Center
Must not be taking: Anticoagulants, Antiplatelets
Disqualifiers: Neurological disorder, Hypertension, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking anticoagulants or antiplatelet drugs other than aspirin.
What data supports the effectiveness of this treatment for PTSD?
Research shows that stellate ganglion block (SGB), an anesthetic treatment, has been successful in reducing PTSD symptoms in military service members and other patients. Several studies, including a randomized clinical trial, have reported positive outcomes, suggesting SGB may help relieve severe and chronic PTSD symptoms.
12345Is the stellate ganglion block (SGB) procedure safe for humans?
The stellate ganglion block (SGB) has been used since 1925 with very few side effects reported, making it generally safe for humans. It involves injecting a local anesthetic in the neck to help with symptoms of PTSD and has been well-tolerated in studies with patients.
14567How does the PTSD treatment using Cognitive Processing Therapy and Stellate Ganglion Block differ from other treatments?
This treatment is unique because it combines Cognitive Processing Therapy (a type of talk therapy) with Stellate Ganglion Block (SGB), an injection of anesthetic near a group of nerves in the neck, which has shown promise in reducing PTSD symptoms. SGB is a novel approach for PTSD, traditionally used for pain relief, and may enhance the effectiveness of trauma-focused therapies.
12489Eligibility Criteria
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.Inclusion Criteria
I experience symptoms that suggest I have PTSD.
I am between 18 and 70 years old.
Ability to read and write English sufficiently to understand and complete study questionnaires and participate in interviews
+2 more
Exclusion 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.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either 1-week massed CPT treatment, 2 SGB treatments, or usual care
4 weeks
Multiple visits for assessments on study days 1, 7, 14, 21, 28
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Follow-up assessments on study days 56 and 112
Participant Groups
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.
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.
Cognitive Processing Therapy is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Cognitive Processing Therapy for:
- Posttraumatic Stress Disorder (PTSD)
🇪🇺 Approved in European Union as Cognitive Processing Therapy for:
- Posttraumatic Stress Disorder (PTSD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rush University Medical CenterChicago, IL
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Who Is Running the Clinical Trial?
Rush University Medical CenterLead Sponsor
United States Department of DefenseCollaborator
References
A review of the use of stellate ganglion block in the treatment of PTSD. [2018]Current treatments for PTSD are often not effective or acceptable to the patient. There are a number of emerging new treatments. One promising new one is stellate ganglion block, an anesthetic treatment for pain which relieves symptoms of severe and chronic PTSD in some patients. The focus of this chapter is to summarize clinical evidence available for the effectiveness of cervical sympathetic ganglion injection called stellate ganglion block (SGB), as well as demonstrate possible clinical applications of its use. Cervical sympathetic blockade involves injecting a local anesthetic next to a group of nerves (ganglion) in the neck. The technique has been used clinically since 1925 with very few side effects. Finally, the neurobiology of SGB is discussed. Challenges to the use of SGB include the lack of randomized clinical trials and practitioners familiar with the use of SGB for PTSD.
Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. [2021]This is the first multisite, randomized clinical trial of stellate ganglion block (SGB) outcomes on posttraumatic stress disorder (PTSD) symptoms.
Stellate Ganglion Block for the Treatment of Posttraumatic Stress Disorder: A Randomized, Double-Blind, Controlled Trial. [2019]In this study, we aimed to determine if stellate ganglion block (SGB) could reduce symptoms of posttraumatic stress disorder (PTSD) in comparison with sham therapy in military service members.
The use of stellate ganglion block in the treatment of panic/anxiety symptoms with combat-related post-traumatic stress disorder; preliminary results of long-term follow-up: a case series. [2022]Report the successful use of stellate ganglion blocks (SGBs) in two patients experiencing symptoms of post-traumatic stress disorder (PTSD).
Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. [2018]Report the successful use of stellate ganglion blocks (SGBs) in 166 active duty service members with multiple combat deployments experiencing anxiety symptoms associated with post-traumatic stress disorder (PTSD).
The Successful Use of Left-sided Stellate Ganglion Block in Patients That Fail to Respond to Right-sided Stellate Ganglion Block for the Treatment of Post-traumatic Stress Disorder Symptoms: A Retrospective Analysis of 205 Patients. [2022]Ultrasound-guided stellate ganglion block (SGB) is an injection of local anesthetic (8mL of 0.5% ropivacaine) in the neck to temporarily block the cervical sympathetic trunk which controls the body's fight-or-flight response. This outpatient procedure takes less than thirty minutes and is immediately effective. Our goal was to determine if a left-sided stellate ganglion block is effective for treating posttraumatic stress disorder (PTSD) symptoms. While right-sided SGB has been extensively studied, left-sided SGB has not been formally evaluated for this indication.
Safety and Patient Acceptability of Stellate Ganglion Blockade as a Treatment Adjunct for Combat-Related Post-Traumatic Stress Disorder: A Quality Assurance Initiative. [2020]To perform a quality assurance and performance improvement project through review of our single center data on the safety and patient acceptability of the stellate ganglion blockade (SGB) procedure for the relief of symptoms related to chronic post-traumatic stress disorder.
Combining a stellate ganglion block with prolonged exposure therapy for posttraumatic stress disorder: A nonrandomized clinical trial. [2022]Prolonged exposure therapy (PE) is an efficacious treatment for active duty service members and veterans with posttraumatic stress disorder (PTSD). However, PE is sometimes associated with high dropout rates, limited tolerability, and temporary symptom exacerbation during treatment. Stellate ganglion blocks (SGBs) are an emerging treatment that has the potential to enhance outcomes for PTSD when combined with trauma-focused psychotherapy. To date, no study of which we are aware has examined the potential additive benefits of SGB injections when administered in conjunction with trauma-focused behavioral treatment for PTSD. Thus, we conducted a nonrandomized clinical trial to evaluate the use of an SGB combined with massed PE therapy for combat-related PTSD. Participants (N = 12) were treated with 10 daily 90-min PE sessions delivered over 2 weeks and received a single SGB injection between Sessions 1 and 2. PE sessions lasted 90 min each. Participants reported a mean posttreatment PTSD symptom reduction of 32 points on the PTSD Checklist for DSM-5 (PCL-5), Hedges' gs = 1.28-2.80. Most participants (90.9%) demonstrated clinically significant change on the PCL-5 (i.e., ≥10 points) by the final treatment session and 50.0% no longer met the diagnostic criteria for PTSD per the Clinician-Administered PTSD Scale for DSM-5 at 1-month follow-up. Adverse events for the combined treatment were consistent with those previously reported for standalone SGB and PE. This combined treatment approach provides promising results for improving the tolerability of trauma-focused therapies, reducing symptom severity, and increasing PTSD remission rates.
Successful use of stellate ganglion block and pulsed radiofrequency in the treatment of posttraumatic stress disorder: a case report. [2021]Objective. To report our successful treatment of acute symptoms of posttraumatic stress disorder (PTSD). By the use of stellate ganglion block (SGB) and pulsed radiofrequency (PRF) to the stellate ganglion(SG) , sequentially. Background. A 48-year-old male a victim of armed robbery , who presented with extreme symptoms consistent with the diagnosis of PTSD. He was treated with antianxiety medications, as well as psychotherapy, but his symptoms persisted. Methods. Fifty-five days post trauma, we administered a SGB to the patient. One month later, we administered PRF to the right SG . We repeated the pulsed radiofrequency 30 weeks post trauma and performed a second SGB two weeks after that. Results. After the SGB , the patient experienced a major reduction in anxiety. Over the next week his improved allowing a significant reduction of antianxiety medications. One month later the symptoms returned and again subsided substantially following PRF , and that relief lasted four months. The patient than required another following PRF and a SGB with good responses. Conclusion. We report that selective blockade of the stellate ganglion via injection and the treatment with PRF, relieved our patient's symptoms of PTSD. And we also provide a plausible explanation of the effect.