A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Post Traumatic Stress Disorder (PTSD)
- Sponsor
- United States Naval Medical Center, San Diego
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Clinician Administered PSTD Scale (CAPS)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Post Traumatic Stress Disorder (PTSD), is a devastating condition which causes distress or impairment in social, occupational or other important aspects of functioning. The occurrence of PTSD in the military is on the rise. This has significantly impacted military members, their families, and society as a whole. According to an expert panel convened by the Institute of Medicine in 2007, the effectiveness of most currently employed PTSD therapies is low. Safe and effective treatments are urgently needed. The specific aim of this investigation is to evaluate the effectiveness of a novel approach to relieve PTSD symptoms, utilizing a procedure commonly used in pain management, a Stellate Ganglion Block (SGB) with local anesthesia. Male soldiers experiencing moderate to severe symptoms of PTSD will be recruited for evaluation of Stellate Ganglion Block with local anesthesia as an intervention for PTSD treatment. Participants will be randomized to receive either the SGB with local anesthesia to C6 tubercle or a sham procedure involving a subcutaneous saline injection to the neck. The PTSD symptoms before and after the procedure will be measured using a comprehensive clinician-administered scale, self-report measures, objective measures of cognitive ability, and physiologic reactivity measures. Subjects will undergo assessment prior to the procedure, one week following the procedure, one month and 3 months following the procedure. Patients receiving sham injections will be allowed to cross over to the treatment group. Based on published case reports of Lipov et al in Chicago and Mulvaney et al from Walter Reed Medical Center, who utilized this technique to successfully treat soldiers with combat-related PTSD, we predict that the use of Stellate Ganglion Block will result in reduction of PTSD symptoms as measured by clinician-administered scales, self-report measures, objective measures of cognitive ability, and physiologic reactivity measures, leading to a significant and lasting reduction of PTSD symptoms.
Investigators
Steven Hanling
Department of Psychaitry Research Director, Mental Health Directorate
United States Naval Medical Center, San Diego
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Clinician Administered PSTD Scale (CAPS)
Time Frame: 1 week
The CAPS is generally considered the gold standard for PTSD assessment, and will be used to determine severity of PTSD symptoms compared to the 1 week pre baseline measures at enrollment
Secondary Outcomes
- Sheehan Disability Scale (SDS)(1 week)
- Behavioral Reactivity Test (BRT)(1 week)
- PTSD Checklist Military Version (PCL-M)(1 week)
- Beck Anxiety Inventory (BAI)(1 week)
- Automated Neuropsychological Assessment Metric (ANAM)(1 week)
- The Patient Health Questionnaire 9 (PHQ-9)(1 week)