Cervical Plexus Hydrodissection With D5W for PTSD

Dr. Dean Reeves Clinic

Status: Enrolling

Conditions: PTSD

Treatments: Procedure: BCPHD with D5W; Procedure: Waiting period with usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04421573

DextrosePTSD1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 19 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

BCPHD-D5W with usual care

Experimental group

Description:

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.

Treatment:

Procedure: BCPHD with D5W

Waiting period with usual care

Active Comparator group

Description:

All helpful treatment methods already underway are continued. Other new treatment methods are discouraged.

Treatment:

Procedure: Waiting period with usual care