A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder
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ClinicalTrials.gov Identifier: NCT01629537 |
Recruitment Status :
Completed
First Posted : June 27, 2012
Last Update Posted : March 30, 2017
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | April 2016 |
Actual Study Completion Date : | April 2016 |
Arm | Intervention/treatment |
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Placebo
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.
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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.
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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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- Gender: Male and Female
- Minimum Age/ Maximum Age: Over the age of 18
- Accepts Healthy Volunteers:
Yes, but must be experiencing mild to severe symptoms of PTSD
Inclusion Criteria will include subjects who:
- Subjects, (male and/or female), experiencing moderate-to-severe PTSD Symptoms
- Subjects, (male and/or female), who elect to undergo the SGB procedure.
- DEERS Eligible
Exclusion Criteria will include subjects who:
- Have an acute, unstable medical condition i.e., temperature, blood pressure, heart rate outside normal limits; electrolyte abnormalities; mental conditions which preclude informed consent/unable to make decisions independently; on antibiotic therapy; uncontrolled seizures; nausea/vomiting; night sweats; blood dyscrasias.
- Have acute infections or cardiac compromise or irregularities of heart rate or rhythm.
- Pathologic bradycardia
- Have local infections of the anterior neck region
- Have severe pulmonary disease, (in severe pulmonary disease, the patient may experience severe shortness of breath on minimal exertion [even at rest], require supplemental oxygen, is progressively disabled and may have a constant cough and associated wheeze).
- Are anticoagulated
- Have a blood clotting disorder
- Have an American Society of Anesthesiologists (ASA) physical status score of 3 or higher (severe systemic disease, not incapacitating)
- Have allergic reactions to local anesthetics and / or contrast dyes,
- Have conditions or disorders that affect cognitive functioning, including stroke, past or present diagnosis of psychosis,
- Have conditions that invalidate testing procedures (e.g., English not first language, inability to write, speak, read, etc.)
- Have Horner's syndrome on the right side
- Have a diagnosis of glaucoma
- Are pregnant
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 |
Responsible Party: | Steven Hanling, Department of Psychaitry Research Director, Mental Health Directorate, United States Naval Medical Center, San Diego |
ClinicalTrials.gov Identifier: | NCT01629537 |
Other Study ID Numbers: |
NMCSD.2010.0157 |
First Posted: | June 27, 2012 Key Record Dates |
Last Update Posted: | March 30, 2017 |
Last Verified: | March 2017 |
Post Traumatic Stress Disorder |
Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders |