PTSD
Conditions
Keywords
Dextrose, Hydrodissection, Cervical Plexus
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREBCPHD with D5W
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.
PROCEDUREWaiting period with usual care
Same as previous group description
Sponsors
Dr. Dean Reeves Clinic
Paul Johnson, D.O.
Eric Phillippi, M.D.
Ryan Wood, N.D.
Danesh Mazloomdoost
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized open-label crossover study comparing BHDCP with D5W versus a waiting period in which usual care is allowed.
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Not involved in another study of PTSD treatment * Reliable transportation * Comfortable with computers * Tried 2 or more medications for treatment of PTSD symptoms * Tried 2 or more non-medication treatments for PTSD symptom * No known life-threatening illness * Not taking daily narcotics * Not having 3or more alcoholic drinks on an average day * No active suicidal plans * No major surgery plans * No major life stress that might interfere with completing study * Symptoms for more than 1 year * Not planning to move for next 18 months. * Living within an hour of Portlland, OR, Madison, WI, or Lexington, KY * Wiling to provide 2 email and 2 phone contact methods * Willing to answer questions on multiple occasions over the course of a year. * Willing to be assigned to 3 months of usual care treatment * No diagnosis of schizophrenia, Borderline Personality Disorder, or Bipolar Disorder. * No severe needle phobia * Chronic pain ≤ 5/10 * PCL-C score ≥ 50
Exclusion criteria
None separate from inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consent rate | 3 months | Percentage consent rate for qualifying participants |
| Data Capture rate | 3 months | Percentage data capture |
| Satisfaction rating | 3 months | Satisfaction with treatment outcome as measured by a 0-10 Numerical Rating Scale (NRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PCL-C Score | 3 months | Improvement (reduction) in PTSD check list for civilians |
| HADS scale | 3 months | Improvement in the Hospital Anxiety and Depression Scale |
| EuroQOL 0-100 | 3 months | 0-100 rating of quality of life |
| Qualitative interview | Nine to twelve months after receiving first D5W treatment for PTSD | Qualitative interview |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKenneth D Reeves, M.D.
Dr. Dean Reeves Clinic
Outcome results
None listed