Cervical Plexus Hydrodissection With D5W for PTSD

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04421573
• Other study ID #: DextrosePTSD1
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: October 1, 2027

Study information

• Verified date: February 2024
• Source: Dr. Dean Reeves Clinic
• Contact: Kenneth D Reeves, M.D.
• Phone: 9133621600
• Email: DeanReevesMD[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: October 1, 2027
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

Procedure:
• BCPHD with D5W
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.
• Waiting period with usual care
Same as previous group description

Locations

Country	Name	City	State
Canada	Entheomed Clinic	Kelowna	British Columbia
Canada	Drs. David & Jannice Bowler, Inc.: Bowler Medical Clinic	Victoria	British Columbia
China	Stanley H.K. Lam Clinic	Hong Kong	Hong Kong

Sponsors (5)

Lead Sponsor	Collaborator
Dr. Dean Reeves Clinic	Francois Louw, M.D, Jannice Bowler, M.D., Paul Johnson, D.O. Asserted to be a recognized organization, Stanley Lam, M.D.

Countries where clinical trial is conducted

Canada,  China, 

References & Publications (1)

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 Tre — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consent rate	Percentage consent rate for qualifying participants	3 months
Primary	Data Capture rate	Percentage data capture	3 months
Primary	Satisfaction rating	Satisfaction with treatment outcome as measured by a 0-10 Numerical Rating Scale (NRS)	3 months
Secondary	PCL-C Score	Improvement (reduction) in PTSD check list for civilians	3 months
Secondary	HADS scale	Improvement in the Hospital Anxiety and Depression Scale	3 months