Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial

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.

Conflict of interest statement

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.

Figures

Figure 1.. Study Screening, Enrollment, and Loss to Follow-up at Each Stage

Exclusion by emergency protocol indicates patients who were excluded because of suicidal ideation at a screening visit. Other patients were ineligible because of having previously received a stellate ganglion block (SGB), not being on active duty, not expecting to be stationed at their current location for at least 2 months, not having personal access to email and the Internet, or undergoing medical board/retirement or legal action at the time of the assessment. CAPS-5 indicates Clinician-Administered PTSD Scale for DSM-5; PCL-C, PTSD Checklist–Civilian Version.

Figure 2.. Unadjusted Clinician-Administered Posttraumatic Stress Disorder Scale for DSM-5 (CAPS-5) Total Symptom Severity Score at Baseline and Week 8 by Treatment Group

Within each box plot, the top of the box represents the 75th percentile, the diamond represents the mean, the horizontal line within the box represents the median, and the bottom of the box represents the 25th percentile. The upper and lower ends of the whiskers correspond to the highest value and the lowest value, respectively.