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CompletedNCT05534126SGBUpdated Oct 24, 2025

Enhancing Cognitive Processing Therapy for Posttraumatic Stress Disorder Via Stellate Ganglion Block Treatment: A Pilot Trial

An interventional study of Stellate Ganglion Block Treatment and Placebo in Posttraumatic Stress Disorder and Chronic Pain, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-24.

Sponsored by Rush University Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Cognitive Processing Therapy (CPT) is an effective first-line, evidence-based treatment for posttraumatic stress disorder (PTSD). Despite its well-demonstrated effectiveness, research has shown that approximately two-thirds of individuals continue to meet the diagnostic criteria for PTSD even after successful treatment completion. Stellate Ganglion Block (SGB) treatment, involving a local anesthesia injection to the stellate ganglion (around the lower base of the neck), has been shown to block its pain signal transmissions. Prior case studies and reviews have provided evidence for reducing PTSD symptoms with SGB treatment. However, studies to date have only examined SGB as a standalone intervention. The utility of combining CPT with concurrent SGB treatment remains unknown, although it is plausible that the combination of the two treatments can improve the effectiveness of CPT alone. The present study aims to test this hypothesis by comparing either a combined 1-week massed CPT + SGB treatment and 1-week massed CPT + placebo treatment (saline injection) using a randomized controlled trial design.

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Conditions studied

  • Posttraumatic Stress Disorder
  • Chronic Pain
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In context

Stress Disorders, Post-Traumatic

2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Are 18 years or older
  2. Are fluent in English
  3. Reside in Illinois
  4. Have safe transportation means other than driving themselves to Rush University Medical Center for two separate procedures (e.g., Uber, family or friend to drive them to study visits, etc.)
  5. Have experienced a Criterion A traumatic event during their lifetime
  6. Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM-5
  7. Have not previously received stellate ganglion blocks
  8. Are willing and able to participate in daily Cognitive Processing Therapy over the course of one week
  9. Are willing and able to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study

Exclusion criteria

Exclusion Criteria:

  1. The traumatic event occurred in the past month
  2. They are currently suicidal or homicidal (i.e., plan and intent)
  3. They have unmanaged psychosis or mania
  4. They have not been on a stable dose of psychotropic medication for at least one month by the time of the baseline assessment or are planning to change their medications within 3 months of starting their participation in the study
  5. They have completed an evidence-based cognitive behavioral PTSD treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure) in the past 12 months or are currently receiving an evidence-based PTSD treatment
  6. They have an intellectual disability or significant cognitive impairment that would prevent them from engaging in CPT, as assessed via the Mini-Mental State Exam-Second Edition (MMSE-2)
  7. They are currently on any blood-thinning medications or have a coagulopathy
  8. They have any of the following conditions: a recent myocardial infarction, glaucoma, a pre-existing contralateral nerve palsy, severe emphysema or a cardiac conduction blockade.
  9. They are allergic to any of the medications injected (i.e., ropivacaine, lidocaine, propofol, medications)
  10. They have an active infection
  11. They have a serious or unstable medical illness or instability for which hospitalization may be likely within the next year
  12. They have a visual or auditory impairment that would prevent them from fully participating in study activities
  13. They are involved with current legal actions related to the traumatic event that is anticipated to be targeted during treatment
  14. Subjects who, at the time of consent, appear to have extenuating life circumstances (e.g., unstable housing, no internet access, etc.) which, in the judgement of the Principal Investigator, could affect the ability to deliver the intervention with fidelity
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Stellate Ganglion Block

    Procedure: Stellate Ganglion Block Treatment

  • Placebo comparator
    Placebo

    Procedure: Placebo

Interventions

  • ProcedureStellate Ganglion Block Treatment

    Stellate ganglion block procedure is a treatment that involves injection of local anesthetic around the stellate ganglion (located at the base of the neck) to block its transmission of pain signals.

  • ProcedurePlacebo

    Sham

06

What researchers measure

Primary outcomes

  1. Clinician Administered PTSD Scale for DSM-5

    Clinician Administered Assessment of PTSD

    Time frame: Through study completion, on average of 3 months

  2. PTSD Checklist for DSM-5 Criteria

    Self-report measure for PTSD

    Time frame: Through study completion, on average of 3 months

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Study locations

1 site
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05534126
Lead sponsor
Rush University Medical Center
Responsible party
Philip Held (Research Director, Rush University Medical Center) — Principal investigator
First posted
Sep 9, 2022
Start date
Nov 1, 2022
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025
Last update
Oct 24, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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