A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of POST TRAUMATIC STRESS DISORDER
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | June 2011 |
| End Date: | September 2012 |
| Contact: | Steven Hanling, MD, CDR |
| Email: | Steven.Hanling@med.navy.mil |
| Phone: | 619-532-8964 |
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.
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.
1. Gender: Male and Female
2. Minimum Age/ Maximum Age: Over the age of 18
3. 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.
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.
- Pathlogic 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
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