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 an injection control of normal saline (NS)
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 is under evaluated in a randomized trial compared treatment with D5W versus delayed treatment with early results promising. This study is designed as the next step in study quality through use of an injection control. The primary outcome is the short term and long-term effect of BHDCP with D5W versus NS on the Post Traumatic Stress Disorder Check List for Civilians (PCL-C), The primary hypotheses are tha cervical plexus hydrodissection with D5W will outperform NS for the primary measure, and that the PCL\_C improvement will be equal to or greater than 15.3 (1.5 times the MCID of 10.2.). A study size of 100 participants is planned, based on power analysis.
Interventions
DRUGDextrose 5% in water bilateral injection
Injection under the investing fascia of the sternocleidomastoid muscle
DRUGNormal saline bilateral injection
Injection under the investing fascia of the sternocleidomastoid muscle
Sponsors
Dr. Dean Reeves Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The statistician is masked as well
Intervention model description
Randomized double-blind study comparing BHDCP with D5W versus NS
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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 3 or 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 Portland, 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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post traumatic checklist for civilians | 3 months | Minimum 17 Maximum 85 Higher scores mean worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital anxiety and depression scale | 3 months | Minimum 0 Maximum 42 Higher scores mean worse outcome |
| EuroQol Visual Analog Scale (0-100 overall quality of life) | 3 months | Minimum 0 Maximum 100 Higher scores mean better outcome |
Countries
United States
Contacts
CONTACTKenneth D Reeves, MD
CONTACTClare R Solso, RN
PRINCIPAL_INVESTIGATORKenneth D Reeves, M.D.
Dr. Dean Reeves Clinic
Outcome results
None listed