Cervical Plexus Hydrodissection With D5W for PTSD

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The primary objective of this study is to determine the short term effects of BHDCP with D5W on anxiety and longer-term effects on the Post Traumatic Stress Disorder Check List for Civilians (PCL-C), The primary hypotheses are that BHDCP with D5W will outperform a waiting/usual care group in both anxiety reduction and PCL-5 score improvement. A study size of 24 is planned, based on power analysis.

Official Title
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Cervical Plexus Hydrodissection With D5W for PTSD Versus Delayed Treatment/Usual Care

Conditions
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PTSD

Intervention / Treatment
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* Procedure: BCPHD with D5W
* Procedure: Waiting period with usual care


Participation Criteria
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Eligibility Criteria
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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, 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized open-label crossover study comparing BHDCP with D5W versus a waiting period in which usual care is allowed.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCPHD-D5W with usual care<br>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. | Procedure: BCPHD with D5W<br>* 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.<br>|
| Active Comparator: Waiting period with usual care<br>All helpful treatment methods already underway are continued. Other new treatment methods are discouraged. | Procedure: Waiting period with usual care<br>* Same as previous group description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCL-C Score | Measurement of response to very stressful experiences in the last month. Range from 0 to 80. An improvement is a reduction in the PCL-5 score. | 3 months | 
| Hospital Anxiety and Depression scale | Measurement of symptoms of anxiety and depression. Range from 0 to 21. An improvement is a reduction in the HADS score. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with treatment outcome as measured by a 0-10 Numerical Rating Scale (NRS) | Anchors include 0 = no satisfaction and 10 = complete satisfaction | 3 months | 
| EuroQOL-5D-5L + C scale | Measurement of general quality of life. Each question has a range from 1 to 5. An improvement is a reduction in score. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dextrose, Hydrodissection, Cervical Plexus