Sign in
Active, not recruitingNo phase

Stellate Ganglion Block for PTSD

Key facts

Who runs it
VA Office of Research and Development
Where
Long Beach, Madison, Minneapolis, Salt Lake City, Tampa, and White River Junction, United StatesSee the 6 sites
Trial code
Status
Active, not recruiting
People taking part
410 people enrolled
Started
17 Nov 2022
Ended
30 Jun 2026
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Stellate Ganglion Block
  • Sham Stellate Ganglion Block
Record updated
3 December 2025

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • Veterans of any military branch
  • DSM-5 criteria for chronic PTSD on the Clinician Administered PTSD Scale (CAPS-5)
  • at least moderate PTSD with a total CAPS-5 score of > 26
  • having had at least one trial of an evidence-based treatment (EBT) for PTSD; Verification of an EBT trial will be by:
  • subject report of engaging in the EBT (whether it be psycho- or pharmaco-therapy)
  • CPRS or other medical record system (if outside VA) verification to determine that the dose and time (applies to both meds and therapy) was an adequate trial OR that they clearly did not finish the EBT due to clear aversion; They will be eligible if they did not finish the EBT due to aversion, but they must have had a trial and be fully informed during informed consent for this study of the available clinical treatment options; Eligible persons may have other symptoms that are commonly comorbid with PTSD (e.g., anxiety, moderate depression); Severe primary depression will be an exclusion (see "Exclusion criteria" below); This strategy will provide a feasible and generalizable sample; Women and minorities will be recruited

Who cannot take part

  • thyroid disease and other contraindications to SGB (anatomic abnormalities of the anterior cervical spine; cardiac/pulmonary compromise; acute illness/infection; coagulopathy/bleeding disorder; allergic reactions/contraindications to local anesthetic or contrast dye, prior anterior neck surgery, anterior neck skin abnormalities (rash or eruptions))
  • centrally acting medications that have a potential effect on biological expression
  • pain levels requiring opiate medications
  • past clear and chronic PTSD prior to military service
  • current active psychotherapy for PTSD (they may suspend therapy if chosen by subject and therapist)
  • having had any prior SGB
  • unstable dose(s) of medication for depression, anxiety, PTSD, or for sleep, or any other psychoactive medication for 8-weeks prior to intervention
  • unwillingness to continue active medications at the same doses for the duration of the trial; a person who is on a stable medication dose for > 8 weeks who meets inclusion criteria and will continue these medications for the trial duration will not be excluded
  • decisional incapacity (e.g., dementia, clear evidence of testing that signifies incapacity to consent), OR Montreal Cognitive Assessment score <18
  • a diagnosed and untreated moderate or severe sleep breathing disorder (SBD), OR a high risk of a SBD as indicated by snoring >50% of nights plus one of; any witnessed apnea; feeling non-refreshed in the morning >50% of mornings; daytime sleepiness indicated by falling asleep with routine tasks such as watching TV or reading
  • clear current and past six-months psychosis clearly not related to PSTD hypervigilance,
  • substance dependence (clear evidence of tolerance and/or withdrawal) within the past 6 months
  • known exposure to chemicals or physical trauma that cause permanent neuropsychiatric sequelae
  • severe depression (Quick Inventory of Depression-SR16 (QIDS-SR16 score >18) that is deemed more clinically significant than PTSD (i.e., depression, cluster D PTSD, and minimal symptoms from cluster B, C, and E)
  • high risk of acute suicidality
  • clear treatment non-adherence indicated by stopping treatment or >3 missed appointments in the course of at least three PTSD EBTs
  • pregnancy

Where in United States

  • VA Long Beach Healthcare System, Long Beach, CALong Beach, United States
  • William S. Middleton Memorial Veterans Hospital, Madison, WIMadison, United States
  • Minneapolis VA Health Care System, Minneapolis, MNMinneapolis, United States
  • VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake City, United States
  • James A. Haley Veterans' Hospital, Tampa, FLTampa, United States
  • White River Junction VA Medical Center, White River Junction, VTWhite River Junction, United States

About the trial

What the trial wants to find out

Posttraumatic Stress Disorder (PTSD) is a debilitating condition that affects about 15% of Veterans. Current treatments for Veterans with PTSD include medications and psychological therapies that help to process and desensitize to traumatic events. While effective for many, these treatments do not work for all patients, and many may refuse them. Stellate Ganglion Block (SGB), established to treat pain and other conditions, has shown promise for PTSD: early small studies show it may work fast and greatly reduce symptoms. However, data from larger studies are not clear about SGBs effects. A definitive trial is needed, especially for the Veteran population. This large, well-powered, randomized, sham-controlled trial of SGB for PTSD will assess the short-term efficacy of this intervention, the durability of the effects and the safety of the treatment. Additionally, this study will provide critically important information about biological effects of SGB and potential mechanisms of action. This timely study is critical to help VA clinicians better decide about the merits of SGB for PTSD.

The 3 groups in the trial

  • SGBExisting treatment, for comparison

    SGB, the experimental procedure, is the injection of 7 cc of 0.5% ropivacaine plus 0.5 cc contrast anterior to the prevertebral fascia at the ventral aspect of the longus colli muscle, medial to Chassaignac's tubercle

    Treatment: Stellate Ganglion Block

  • ShamSham treatment, for comparison

    Sham, the placebo control group, is the injection of 7 cc of normal saline plus 0.5 cc contrast anterior to the prevertebral fascia at the ventral aspect of the longus colli muscle, medial to Chassaignac's tubercle

    Treatment: Sham Stellate Ganglion Block

  • Wait-List Control (WLC)No study treatment, for comparison

    WLC, a control for time, expectancy and safety, is all study procedures without going to the procedure room for injection

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Efficacy and Safety of Stellate Ganglion Block for Post-traumatic Stress Disorder in Veterans
Publications
Record updated
3 December 2025