A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder
|ClinicalTrials.gov Identifier: NCT01629537|
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : March 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder (PTSD)||Procedure: Stellate Ganglion Block injection with ropivicane Procedure: Placebo Procedure||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder|
|Study Start Date :||June 2011|
|Primary Completion Date :||April 2016|
|Study Completion Date :||April 2016|
Subjects 1 month post in the placebo group who demonstrate either the same level of PTSD severity at enrollment or worsening of the condition (i.e., CAPS score greater than or equal to 40) will be offered SGB treatment and crossed over to active treatment. Patients who cross over from placebo to active SGB treatment will be followed one week, one month and three months after cross over.
Procedure: Placebo Procedure
In participants randomized to the placebo injection, the same positioning, monitoring, sterile preparation and technique and local anesthesia protocol will be used. The 22 g needle will instead be placed in the subcutaneous, superficial tissues overlying the C6 tubercle, but superficial enough that the prevertebral fascial plane of the stellate ganglion will not be breached. Using fluoroscopic guidance, this needle will be injected with 2 cc of contrast dye to confirm superficial spread. The needle will then be injected with 5 cc of preservative free normal saline and the needle will be removed.
Experimental: Stellate Ganglion Block (SGB)
Subjects assigned to SGB arm will undergo SGB procedure and be followed one week, one month and three months after procedure or until CAPS score is below 40.
Procedure: Stellate Ganglion Block injection with ropivicane
For participants receiving the stellate ganglion injection with ropivicaine, a 22 g needle will be directed percutaneously to the anterolateral C6 vertebral body Using ultrasound guidance to avoid the nearby vascular structures and identify the appropriate vertebral level and tissue plane. After negative aspiration for blood and CSF, and digital subtraction, 2cc of Iohexol,(Omnipaque 180) will be injected through the needle under live fluoroscopy to visualize dye spread over the pre-vertebral plane At this point, 7 cc 0.5% ropivicaine will be injected and the needle will be removed.
- 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
- PTSD Checklist Military Version (PCL-M) [ Time Frame: 1 week ]The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. It is used to screen and diagnose individuals for PTSD, as well as monitoring symptom change during and after treatment. To be compared to the 1 week pre baseline measures at enrollment
- The Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: 1 week ]The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. To be compared to the 1 week pre baseline measures at enrollment
- Beck Anxiety Inventory (BAI) [ Time Frame: 1 week ]A 21-question multiple-choice self-report inventory that is used for measuring the severity of an individual's anxiety. To be compared to the 1 week pre baseline measures at enrollment
- Sheehan Disability Scale (SDS) [ Time Frame: 1 week ]Assesses disability in work/school activities, family relationships, and social functioning, and it evaluates the functional impact of psychiatric disorders. To be compared to the 1 week pre baseline measures at enrollment
- Behavioral Reactivity Test (BRT) [ Time Frame: 1 week ]To be compared to the 1 week pre baseline measures at enrollment
- Automated Neuropsychological Assessment Metric (ANAM) [ Time Frame: 1 week ]Computer-based assessments of cognitive domains including attention, concentration, reaction time, memory, processing speed, and decision-making. Evaluate changes in an individual's cognitive status over time. To be compared to the 1 week pre baseline measures at enrollment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629537
|United States, California|
|United States Naval Medical Center San Diego|
|San Diego, California, United States, 92134-1005|
|Principal Investigator:||Steven Hanling, MD, CDR||United States Naval Medical Center, San Diego|