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Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder SymptomsA Randomized Clinical Trial

Educational Objective
To determine whether paired stellate ganglion block (SGB) treatments at 0 and 2 weeks would result in improvement in mean Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity scores from baseline to 8 weeks.
1 Credit CME
Key Points

Question  How does stellate ganglion block compare with sham treatment in reducing the severity of posttraumatic stress disorder symptoms over 8 weeks?

Findings  In this sham-controlled randomized clinical trial, 2 stellate ganglion block treatments 2 weeks apart were effective in reducing Clinician-Administered PTSD Scale for DSM-5 total symptom severity scores over 8 weeks. The adjusted mean symptom change was −12.6 points for the group receiving stellate ganglion blocks, compared with −6.1 points for those receiving sham treatment, a significant difference.

Meaning  Stellate ganglion block treatment warrants further study as a posttraumatic stress disorder treatment adjunct.

Abstract

Importance  This is the first multisite, randomized clinical trial of stellate ganglion block (SGB) outcomes on posttraumatic stress disorder (PTSD) symptoms.

Objective  To determine whether paired SGB treatments at 0 and 2 weeks would result in improvement in mean Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity scores from baseline to 8 weeks.

Design, Setting, and Participants  This multisite, blinded, sham-procedure, randomized clinical trial used a 2:1 SGB:sham ratio and was conducted from May 2016 through March 2018 in 3 US Army Interdisciplinary Pain Management Centers. Only physicians performing the procedures and the procedure nurses were aware of the intervention (but not the participants or assessors); their interactions with the participants were scripted and limited to the 2 interventions. Active-duty service members on stable psychotropic medication dosages who had a PTSD Checklist–Civilian Version (PCL-C) score of 32 or more at screening were included. Key exclusion criteria included a prior SGB treatment, selected psychiatric disorders or substance use disorders, moderate or severe traumatic brain injury, or suicidal ideation in the prior 2 months.

Interventions  Paired right-sided SGB or sham procedures at weeks 0 and 2.

Main Outcomes and Measures  Improvement of 10 or more points on mean CAPS-5 total symptom severity scores from baseline to 8 weeks, adjusted for site and baseline total symptom severity scores (planned a priori).

Results  Of 190 screened individuals, 113 (59.5%; 100 male and 13 female participants; mean [SD] age, 37.3 [6.7] years) were eligible and randomized (74 to SGB and 39 to sham treatment), and 108 (95.6% of 113) completed the study. Baseline characteristics were similar in the SGB and sham treatment groups, with mean (SD) CAPS-5 scores of 37.6 (11.2) and 39.8 (14.4), respectively (on a scale of 0-80); 91 (80.0%) met CAPS-5 PTSD criteria. In an intent-to-treat analysis, adjusted mean total symptom severity score change was −12.6 points (95% CI, −15.5 to −9.7 points) for the group receiving SGB treatments, compared with −6.1 points (95% CI, −9.8 to −2.3 points) for those receiving sham treatment (P = .01).

Conclusions and Relevance  In this trial of active-duty service members with PTSD symptoms (at a clinical threshold and subthreshold), 2 SGB treatments 2 weeks apart were effective in reducing CAPS-5 total symptom severity scores over 8 weeks. The mild-moderate baseline level of PTSD symptom severity and short follow-up time limit the generalizability of these findings, but the study suggests that SGB merits further trials as a PTSD treatment adjunct.

Trial Registration  ClinicalTrials.gov identifier: NCT03077919

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Accepted for Publication: August 15, 2019.

Corresponding Author: Kristine L. Rae Olmsted, MSPH, RTI International, 3040 E Cornwallis Rd, Research Triangle Park, NC 27709 (krolmsted@rti.org).

Published Online: November 6, 2019. doi:10.1001/jamapsychiatry.2019.3474

Correction: This article was corrected on January 2, 2020, to fix a sentence in the Design, Setting, and Participants subsection of the Abstract that referred to “anesthesiologists performing the procedures” but should have instead said “physicians performing the procedures”; the physicians involved were not all anesthesiologists. The article was corrected online.

Author Contributions: Ms Rae Olmsted and Dr Walters had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Rae Olmsted, Bartoszek, Mulvaney, McLean, Turabi, Young, Kim, Vandermaas-Peeler, Morgan, Constantinescu, Kane, Wallace, Lynch, White, Walters.

Acquisition, analysis, or interpretation of data: Rae Olmsted, Bartoszek, McLean, Turabi, Young, Kim, Vandermaas-Peeler, Morgan, Constantinescu, Nguyen, Hirsch, Munoz, Wallace, Croxford, White, Walters.

Drafting of the manuscript: Rae Olmsted, Mulvaney, Vandermaas-Peeler, Morgan, Kane, Hirsch, Munoz, Walters.

Critical revision of the manuscript for important intellectual content: Rae Olmsted, Bartoszek, McLean, Turabi, Young, Kim, Morgan, Constantinescu, Kane, Nguyen, Wallace, Croxford, Lynch, White, Walters.

Statistical analysis: Rae Olmsted, Morgan, Hirsch, Munoz, Wallace.

Obtained funding: Rae Olmsted, Bartoszek, Walters.

Administrative, technical, or material support: Rae Olmsted, Bartoszek, Mulvaney, McLean, Turabi, Kim, Vandermaas-Peeler, Morgan, Constantinescu, Kane, Nguyen, Lynch, White, Walters.

Supervision: Rae Olmsted, Mulvaney, Turabi, Vandermaas-Peeler, Constantinescu, Lynch, Croxford, White, Walters.

Conflict of Interest Disclosures: Dr Morgan reported grants from US Army Medical Research and Materiel Command Military Operational Medicine Research Program during the conduct of the study and outside the submitted work. Dr Munoz reported having a cooperative agreement for the funding of this study with the Office of the Assistant Secretary of Defense for Health Affairs during the conduct of the study. Dr Wallace reported having a cooperative agreement for the funding of this study with the US Department of Defense during the conduct of the study. Mss Rae Olmsted and Croxford; Drs Bartoszek, Mulvaney, McLean, Turabi, Young, Kim, Constantinescu, Kane, Nguyen, and Hirsch; and Mr Vandermaas-Peeler reported having a cooperative agreement for the funding of this study with the US Army during the conduct of the study. No other disclosures were reported.

Funding/Support: This work was funded by the Office of the Assistant Secretary of Defense for Health Affairs through the Defense Medical Research and Development Program (grant W81XWH-15-2-0015). The US Army Medical Research Acquisition Activity is the awarding and administering acquisition office.

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: The views expressed in this article are solely those of the authors and do not reflect an endorsement by or the official policy of the Department of Defense.

Data Sharing Statement: See Supplement 3.

Additional Contributions: The authors wish to acknowledge the contributions of all procedure nurses, clinic staff, and support staff for their commitment to this study. In addition, we acknowledge the following site personnel: Womack Army Medical Center: Melissa Broadwater, RN, clinical research support, Carol Sheff, BA, research coordinator; Tripler Army Medical Center: Maureen K. Copeskey, MS, research coordinator; Landstuhl Regional Medical Center: Nicu Tirnoveanu, RN; Jeff Tiede, MD; Lester Gresham, MSM; Robert Gomez, AA; Sean Moore, MD; Eden Canite, RN; Lesli Battles, RN; Clifford G. Morgan, PhD; Emily N. Kowalski, BA; and Christian P. Geye, MA, LMFT, CHT, clinical research support. In addition, the authors wish to acknowledge Samuel Blacker, MD, Womack Army Medical Center, for serving as the study’s research monitor; Emily Callot, MS, RTI International, for editing; Catherine Boykin, Judy Cannada, AAS, Loraine Monroe, Roxanne Snaauw, and Susan Beck, BA, RTI International, for document preparation; Nunzio Landi, BA, RTI International, for graphics preparation; and Tony Dragovich, MD, Womack Army Medical Center (now with Blue Ridge Pain Management Associates), for the original study concept. Finally, the authors thank Samantha Charm, MPH, RTI International, for research support; Murrey Olmsted, PhD, RTI International, for methodological guidance; Rhonda Karg, PhD, New Leaf Psychotherapy, for supervision of clinical interviewers; and Anthony Plunkett, MD, for serving as interim site PI at Womack Army Medical Center. No compensation was provided beyond normal compensation of employment.

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