N/A
Completed N=113
Effectiveness and Acceptability of Stellate Ganglion Block for Posttraumatic Stress Disorder Symptoms - Effectiveness
Source: ClinicalTrials.gov NCT03077919 ↗Enrolled (actual)
113
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Clinician Administered PTSD Score (CAPS-5) TSSS — 37.61; 39.82; 25.67; 33.68 score on a scale
Summary
This is a multisite, randomized, blinded, sham-procedure-controlled study to evaluate the efficacy of right-sided stellate ganglion block (SGB) on the acute symptomatology of Post traumatic Stress Disorder (PTSD), evaluated by the Clinician-Administered PTSD Scale (CAPS-5) clinical interview at pre-treatment and at 8 weeks. This entry describes the effectiveness study.The acceptability study is described in a separate entry.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Administered PTSD Score (CAPS-5) TSSS |
37.61; 39.82; 25.67; 33.68 | — |
| SECONDARY PTSD Checklist (PCL-5) |
41.54; 43.23; 29.49; 38.11 | — |
| SECONDARY PTSD Checklist Civilian (PCL-C) |
53.30; 54.95; 42.41; 50.65 | — |
| SECONDARY Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items |
0; 0; 0; 0 | — |
| SECONDARY Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C) |
2.74; 3.18; 2.72; 2.62 | — |
| SECONDARY Kessler Psychiatric Distress Scale (K6) |
10.08; 10.33; 7.80; 10.00 | — |
| SECONDARY The Patient Health Questionnaire (PHQ-9) |
12.57; 12.69; 8.68; 11.76 | — |
| SECONDARY Generalized Anxiety Disorder 7-item Survey (GAD-7) |
12.39; 12.49; 8.11; 11.19 | — |
| SECONDARY 12-item Short Form Survey (SF-12) of Physical Functioning |
41.04; 42.01; 43.43; 41.28 | — |
| SECONDARY Short Pain Scale |
4.61; 4.95; 4.10; 4.86 | — |
| SECONDARY Current Medications |
1; 2; 1; 1 | — |
| SECONDARY 12 Item Short Form Survey (SF-12) of Mental Functioning |
41.24; 40.16; 42.83; 40.17 | — |
Eligibility Criteria
Inclusion Criteria
- Member of the Army on active duty status
- Personal access to Internet
- Anticipated stable assignment to installation for at least 2 months
- Stable dosing for ≥3 months, if receiving psychotropic medications
- Prior to enrollment, offered PTSD treatment using A-level modality (as defined by U.S. Army Medical Command (MEDCOM) policy 14-094; 18 Dec 2014).
- PTSD Checklist - Civilian (PCL-C) score of 32 or greater at screening
- Acceptable clinically indicated preoperative laboratory studies, per standard site-specific protocols
Exclusion Criteria
- Prior Stellate Ganglion Block (SGB)
- Allergy to amide local anesthetics (e.g., ropivacaine, bupivacaine)
- Pregnancy (evaluated by urine test pre-procedure)
- Current anticoagulant use
- History of a bleeding disorder
- Infection or mass at injection site
- Myocardial infarction within 6 months of procedure
- Phrenic or laryngeal nerve palsy (hoarseness)
- History of glaucoma
- History of schizophrenia, other psychotic disorder, bipolar disorder, or personality disorder (axis 2)
- Moderate or severe traumatic brain injury
- Symptoms of moderate to severe substance use disorder in past 30 days
- Suicidal ideation in the past 2 months, documented by the M.I.N.I.-Plus Suicidality Items
- Any ongoing other major life stressor or condition not listed here that the site Investigator believes clearly would place the participant at risk for injury or a poor outcome
Data sourced from ClinicalTrials.gov (NCT03077919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.