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| Name | Class |
|---|---|
| Paul Johnson, D.O. | UNKNOWN |
| Eric Phillippi, M.D. | UNKNOWN |
| Ryan Wood, N.D. | UNKNOWN |
| Danesh Mazloomdoost |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCPHD-D5W with usual care | Experimental | Bilateral cervical plexus hydrodissection with D5W (BCPHD-D5W) at 0, 2, 4, and 8 weeks. All helpful treatment methods already underway are continued. Other new treatment methods are discouraged. |
|
| Waiting period with usual care | Active Comparator | All helpful treatment methods already underway are continued. Other new treatment methods are discouraged. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCPHD with D5W | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Consent rate | Percentage consent rate for qualifying participants | 3 months |
| Data Capture rate | Percentage data capture | 3 months |
| Satisfaction rating | Satisfaction with treatment outcome as measured by a 0-10 Numerical Rating Scale (NRS) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| PCL-C Score | Improvement (reduction) in PTSD check list for civilians | 3 months |
| HADS scale | Improvement in the Hospital Anxiety and Depression Scale |
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Inclusion Criteria:
Exclusion Criteria: None separate from inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth D Reeves, M.D. | Dr. Dean Reeves Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danesh Mazloomdoost | Lexington | Kentucky | 40509 | United States | ||
| Paul W. Johnson, D.O., Clinic. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31693083 | Background | Rae Olmsted KL, Bartoszek M, Mulvaney S, McLean B, Turabi A, Young R, Kim E, Vandermaas-Peeler R, Morgan JK, Constantinescu O, Kane S, Nguyen C, Hirsch S, Munoz B, Wallace D, Croxford J, Lynch JH, White R, Walters BB. Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):130-138. doi: 10.1001/jamapsychiatry.2019.3474. |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| UNKNOWN |
Randomized open-label crossover study comparing BHDCP with D5W versus a waiting period in which usual care is allowed.
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| Waiting period with usual care | Procedure | Same as previous group description |
|
| 3 months |
| EuroQOL 0-100 | 0-100 rating of quality of life | 3 months |
| Portland |
| Oregon |
| 87213 |
| United States |
| NW Regen | Tigard | Oregon | 97224 | United States |
| Eric Phillippi M.D. Clinic | Madison | Wisconsin | 53719 | United States |