Updated: May 12
This is the first multisite, randomized clinical trial of stellate ganglion block (SGB) outcomes on symptoms of post-traumatic stress disorder (PTSD).
The importance of this study is to determine whether paired SGB treatments at 0 and 2 weeks would result in an improvement in the mean clinician-administered PTSD scale for DSM-5 Total Symptom Severity Scores (CAPS-5). ) from baseline to 8 weeks.
This randomized, sham-procedural, multi-site, blinded clinical trial used a SGB:sham ratio of 2:1 and was conducted from May 2016 to March 2018 at 3 US Army Interdisciplinary Pain Management Centers. • Only the anesthesiologists performing the procedures and the procedure nurses were aware of the intervention (but not the participants or evaluators); their interactions with the participants were written and limited to the 2 interventions. Active duty service members on stable doses of psychotropic medications who had a PTSD Checklist - Civilian Version (PCL-C) score of 32 or higher at the time of examination were included. Key exclusion criteria included prior treatment for SGB, selected psychiatric or substance use disorders, moderate or severe traumatic brain injury, or suicidal ideation within the previous 2 months.
Improvement of 10 or more points in mean CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) total symptom severity scores from baseline to 8 weeks, adjusted for site and baseline (planned a priori) total symptom severity scores.
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 intention-to-treat analysis, the adjusted mean change in total symptom severity score was −12.6 points (95% CI, −15.5 to −9.7 points) for the group receiving received SGB treatments, compared with −6.1 points (95% CI, −9.8 to −2.3 points) for those receiving sham treatment (P = .01).
In this trial of active duty service members with PTSD symptoms (at clinical and subclinical threshold), 2 SGB treatments 2 weeks apart were effective in reducing CAPS-5 total symptom severity scores for 8 weeks.
The baseline mild-moderate level of PTSD symptom severity and short follow-up time limit the generalizability of these findings, but the study suggests that SGB warrants further trials as an adjunct to PTSD treatment.
For more details on this landmark study go to: