Clinical trial NCT04421573: Cervical Plexus Hydrodissection With D5W for PTSD
Official title: Cervical Plexus Hydrodissection With D5W for PTSD Versus Delayed Treatment/Usual Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Keywords: Dextrose
Hydrodissection
Cervical Plexus
Lead sponsor: Dr. Dean Reeves Clinic
Sponsor class: OTHER
Collaborators: name: Francois Louw, M.D
name: Jannice Bowler, M.D.
name: Stanley Lam, M.D.
name: Paul Johnson, D.O.
name: Eric Phillippi, M.D.
name: Ryan Wood, N.D.
name: Smigel, Liza, M.D.
First posted: 2020-06-09
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized open-label crossover study comparing BHDCP with D5W versus a waiting period in which usual care is allowed.
Primary purpose: TREATMENT

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.

Eligibility 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 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 Kelowna or Victoria, British Columbia, Portland, Oregon, Madison, Wisconsin, or Hong Kong
* 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

Primary outcomes:
measure: Consent rate
timeFrame: 3 months
measure: Data Capture rate
timeFrame: 3 months
measure: Satisfaction rating
timeFrame: 3 months
Secondary outcomes:
measure: PCL-C Score
timeFrame: 3 months
measure: HADS scale
timeFrame: 3 months
Other outcomes:
measure: Cost Efficiency
timeFrame: 0 to 52 weeks
Locations:
city: Hilo
country: United States
facility: Hawaii Center for Regenerative Medicine
state: Hawaii
city: Portland
country: United States
facility: Paul W. Johnson, D.O., Clinic.
state: Oregon
city: Tigard
country: United States
facility: Northwest Regenerative Orthopedics
state: Oregon
city: Madison
country: United States
facility: Eric Phillippi M.D. Clinic
state: Wisconsin
city: Kelowna
country: Canada
facility: Entheomed Clinic
state: British Columbia
city: Victoria
country: Canada
facility: Drs. David & Jannice Bowler, Inc.: Bowler Medical Clinic
state: British Columbia
city: Hong Kong
country: China
facility: Stanley H.K. Lam Clinic
state: Hong Kong
Study officials:
affiliation: Dr. Dean Reeves Clinic
name: Kenneth D Reeves, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.