BCPHD with D5W
ProcedureD5W is injected under the investing fascia of the sternocleidomastoid muscle (SCM) using ultrasound guidance in order to infiltrate the space containing the cervical plexus. This is performed on both sides.
NCT Number: NCT04421573
PTSD is a chronic mental health condition that drastically reduces an individual's quality of life Dextrose injection with a small needle has been used for chronic pain patients and observational results have shown it to be effective in reducing anxiety, brain fog, and depression in patients with PTSD. This randomized trial will compare dextrose injection with a delayed/usual treatment control.
This study is active but is not currently recruiting participants.
19 year–90 year
All sexes
Interventional
Not applicable
Danesh Mazloomdoost, Lexington, Kentucky, United States
PTSD is a well-recognized debilitating mental health condition associated with previous trauma exposure. It is part of the DSM-5 Trauma and Stressor related disorders category. Treatments for PTSD normally involve a multi-disciplinary approach. First-line treatments include psychotherapy and serotonergic reuptake inhibitors. Many patients fail pharmacotherapy and psychotherapy. Unilateral stellate ganglion block performed favorably for treatment of PTSD in a recent RCT, based upon an expectation that the cervical sympathetic system is neuropathically upregulated in PTSD. However, inclusion of lidocaine requires the presence of an emergency response team due to the potential for inadvertent intravascular injection with generalized seizures or hypotension, and inadvertent laryngeal or phrenic nerve block. Perineural injection of peripheral nerves, plexi, or sympathetic ganglia with dextrose 5% in water (D5W), has performed well empirically in the treatment of post-traumatic stress disorder. No lidocaine is utilized, which allows for avoidance of lidocaine toxicity risk, or any risk of nerve block. Because of that, bilateral procedures are feasible, and these procedures can be performed in any outpatient office with ultrasound availability, as emergency team backup is not necessary, making the procedure readily accessible. A cumulative benefit has been observed, as well. The effects of BHDCP with D5W as a stand-alone treatment for PTSD has not been formally evaluated. This small study is designed as a feasibility study with study acceptance rate, protocol adherence, and satisfaction as primary outcomes. Secondary outcomes will include short term and long-term effects of BHDCP with D5W on the Post Traumatic Stress Disorder Check List for Civilians (PCL-C), The primary hypotheses are that the acceptance rate and protocol adherence will both exceed 80%, and satisfaction will be 6/10 or higher on a 0-10 satisfaction scale. A study size of 24 is planned, based on power analysis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
None separate from inclusion criteria
D5W is injected under the investing fascia of the sternocleidomastoid muscle (SCM) using ultrasound guidance in order to infiltrate the space containing the cervical plexus. This is performed on both sides.
Same as previous group description
Time frame: 3 months
Percentage consent rate for qualifying participants
Time frame: 3 months
Percentage data capture
Time frame: 3 months
Satisfaction with treatment outcome as measured by a 0-10 Numerical Rating Scale (NRS)
Time frame: 3 months
Improvement (reduction) in PTSD check list for civilians
Time frame: 3 months
Improvement in the Hospital Anxiety and Depression Scale
Time frame: 3 months
0-100 rating of quality of life
Time frame: Nine to twelve months after receiving first D5W treatment for PTSD
Qualitative interview
Dr. Dean Reeves Clinic
Other
Cervical Plexus Hydrodissection With D5W for PTSD Versus Delayed Treatment/Usual Care
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