PTSD Treatment for Preventing Chronic Pain

Overseen By John Burns, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Neurological disorder, Hypertension, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 57

Duration: 4 weeks

345 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce PTSD symptoms to prevent the transition from temporary to long-term pain. It tests two treatments: Cognitive Processing Therapy (a type of talk therapy) and Stellate Ganglion Block (an injection that may reduce PTSD symptoms). Participants will receive either one of these treatments or usual care. Eligible individuals have acute pain not related to a serious injury and self-reported PTSD symptoms. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for PTSD symptoms.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Processing Therapy (CPT) is generally safe for people with PTSD. In one study, only 6.9% of participants stopped the therapy early, indicating that most continued with it. This aligns with previous findings that CPT improves PTSD and depression symptoms in military and veteran patients.

For Stellate Ganglion Block (SGB), research indicates it is safe and well-tolerated. One study found it effective and safe in reducing PTSD symptoms. SGB does not appear to affect brain functions, so it should not impact thinking or memory.

These findings suggest that both treatments are safe options for helping people with PTSD manage their symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for PTSD because they offer unique approaches to preventing chronic pain. Cognitive Processing Therapy (CPT) stands out as it delivers its sessions in a condensed, 1-week format via telehealth, which could make therapy more accessible and less time-consuming than traditional weekly sessions. On the other hand, Stellate Ganglion Block (SGB) involves a physical procedure that targets the sympathetic nervous system directly, offering a novel way to potentially alleviate symptoms swiftly with just two treatments. Both treatments represent promising alternatives to the usual care that often involves long-term medication or therapy, addressing PTSD and its potential progression to chronic pain in innovative ways.

What evidence suggests that this trial's treatments could be effective for preventing chronic pain in PTSD patients?

In this trial, participants will be randomly assigned to receive either Cognitive Processing Therapy (CPT) or Stellate Ganglion Block (SGB) treatment. Research has shown that CPT reduces PTSD symptoms, with many studies finding significant improvements in PTSD and related issues, such as depression. This improvement also links to better pain management, especially for those who respond well to the treatment.

Meanwhile, SGB has shown promise in reducing PTSD symptoms. Some studies reported that 70% to 75% of people experienced quick improvements in PTSD after receiving SGB. This treatment might also help with other conditions related to PTSD, suggesting it could prevent long-term pain. ^{3 6 7 8 9}

Who Is on the Research Team?

John Burns, PhD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

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.

Ability to read and write English sufficiently to understand and complete study questionnaires and participate in interviews

My main pain is in my chest, back, shoulder, abdomen, or pelvis.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Processing Therapy
• Stellate Ganglion Block

Trial Overview 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.

How Is the Trial Designed?

Group I: Cognitive Processing Therapy Active Control 1 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 Care Active Control 1 Intervention

Participants randomly assigned to the Usual Care condition will not receive any active intervention.

Group III: Stellate Ganglion Block Treatment Active Control 1 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)

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Stellate ganglion block (SGB) is a promising anesthetic treatment that has shown effectiveness in relieving symptoms of severe and chronic PTSD in some patients, despite current treatments often being ineffective or unacceptable.

The technique, which involves injecting a local anesthetic near a group of nerves in the neck, has been used since 1925 with very few side effects, but challenges remain due to a lack of randomized clinical trials and limited practitioner familiarity with its application for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the use of stellate ganglion block in the treatment of PTSD. Lipov, E., Ritchie, EC.[2018]

This multisite, randomized clinical trial involving 113 active-duty service members demonstrated that two stellate ganglion block (SGB) treatments significantly reduced PTSD symptoms, with an average decrease of 12.6 points on the CAPS-5 scale compared to 6.1 points in the sham group.

The study suggests that SGB could be an effective adjunct treatment for PTSD, although the mild-moderate baseline severity of symptoms and short follow-up period may limit the broader applicability of the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. Rae Olmsted, KL., Bartoszek, M., Mulvaney, S., et al.[2021]

In a study of 205 patients with PTSD, 10 patients who did not respond to a right-sided stellate ganglion block (SGB) showed a remarkable 90% improvement in symptoms after receiving a left-sided SGB, with an average improvement of 28.3 points on the PTSD Checklist (PCL-5).

This suggests that left-sided SGB may be an effective alternative treatment for PTSD symptoms in patients who do not respond to right-sided SGB, highlighting the potential for tailored approaches in managing PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Mulvaney, SW., Lynch, JH., Curtis, KE., et al.[2022]

A 48-year-old male with severe PTSD symptoms experienced significant relief after receiving a stellate ganglion block (SGB) 55 days post-trauma, which allowed for a reduction in his antianxiety medications.

Subsequent treatment with pulsed radiofrequency (PRF) to the stellate ganglion also provided substantial symptom relief lasting four months, indicating that these interventions can effectively manage acute PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful use of stellate ganglion block and pulsed radiofrequency in the treatment of posttraumatic stress disorder: a case report. Lipov, E.[2021]

In a randomized trial involving military service members with PTSD, stellate ganglion block (SGB) did not show a significant difference in reducing PTSD symptoms compared to a sham procedure, indicating limited efficacy of SGB for this condition.

While some improvement in PTSD, anxiety, and depression scores was observed over time, the lack of a meaningful difference between the SGB and control groups suggests that SGB may not be a reliable treatment for PTSD, warranting further research into its potential effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stellate Ganglion Block for the Treatment of Posttraumatic Stress Disorder: A Randomized, Double-Blind, Controlled Trial. Hanling, SR., Hickey, A., Lesnik, I., et al.[2019]

In a study of 166 active duty service members with PTSD symptoms, over 70% experienced significant improvement in anxiety symptoms following stellate ganglion blocks (SGB), with effects lasting beyond 3 to 6 months.

The SGB procedure, performed at the C6 level, is considered safe and minimally invasive, offering a promising treatment option for managing PTSD-related anxiety in military personnel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. Mulvaney, SW., Lynch, JH., Hickey, MJ., et al.[2018]

In a nonrandomized clinical trial with 12 participants, combining stellate ganglion blocks (SGB) with prolonged exposure therapy (PE) resulted in a significant reduction in PTSD symptoms, with a mean decrease of 32 points on the PTSD Checklist for DSM-5 (PCL-5).

90.9% of participants showed clinically significant improvement, and 50% no longer met the criteria for PTSD at a 1-month follow-up, suggesting that this combined treatment may enhance the effectiveness and tolerability of trauma-focused therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining a stellate ganglion block with prolonged exposure therapy for posttraumatic stress disorder: A nonrandomized clinical trial. Peterson, AL., Straud, CL., Young-McCaughan, S., et al.[2022]

The stellate ganglion blockade (SGB) procedure for managing chronic post-traumatic stress disorder (PTSD) symptoms was performed safely on 250 patients over 18 months, with no immediate or delayed complications reported.

Patient feedback was overwhelmingly positive, with 100% satisfaction and willingness to recommend the procedure, indicating that SGB is well-tolerated and may provide significant therapeutic value for those with severe PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Patient Acceptability of Stellate Ganglion Blockade as a Treatment Adjunct for Combat-Related Post-Traumatic Stress Disorder: A Quality Assurance Initiative. McLean, B.[2020]

Stellate ganglion blocks (SGBs) at the C6 level provided immediate and significant relief from PTSD symptoms in two soldiers, as evidenced by a substantial drop in their Post-traumatic Stress Disorder Checklist (PCL) scores after treatment.

Both patients were able to discontinue their antidepressant and antipsychotic medications while maintaining their improved mental health, suggesting that SGBs may offer a safe and effective alternative treatment for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Mulvaney, SW., McLean, B., de Leeuw, J.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38091254/

Pain outcomes following a 3-week cognitive processing ... In the present study, we examined changes in pain, PTSD, and depressive symptoms among 125 veterans completing a 3-week cognitive processing ...

2. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/cpt_for_ptsd_pro.asp

Cognitive Processing Therapy for PTSD Participants in the active treatment conditions (both CPT and PE) demonstrated significant improvement in PTSD and depression over the course of treatment as ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1077722922001377

Clinician Concerns About Cognitive Processing Therapy Dozens of clinical trials have demonstrated CPT's efficacy reducing PTSD and related symptoms (e.g., Asmundson et al., 2019, Monson et al., 2006, Resick et al., ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/jts.23143?af=R

Changes in pain and related health outcomes after ... This hypothesis was supported, as service members with PTSD who responded to CPT reported better pain and health outcomes than nonresponders.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04407767

A Case Formulation Approach to Cognitive Processing ... This study will also examine between-group differences across secondary outcomes (e.g. anger, anxiety, health concerns, sleep, numbing/reactivity) and describe ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2829857

Cognitive Processing Therapy for Posttraumatic Stress ... We observed a low proportion of dropouts from CPT (6.9%). Although this finding is consistent with the rate in our pilot trial (1 of 25 [4.0%]), ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589979124000027

Effectiveness of Cognitive Processing Therapy for PTSD in ... This study provides promising data on the outcomes associated with a modified CPT protocol for treating PTSD in a high need but under-treated SMI population.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3336190/

Long-Term Outcomes of Cognitive–Behavioral Treatments ... CPT and PE resulted in lasting changes in PTSD and related symptoms over an extended period of time for female rape victims with extensive histories of trauma.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04230668

NCT04230668 | Cognitive Processing Therapy (CPT) for ... A pilot effectiveness trial of cognitive processing therapy augmented with suicide risk management for individuals with comorbid PTSD and BPD conditions.