Cervical Plexus Hydrodissection With D5W for PTSD
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 96
Summary
- Conditions
- PTSD
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 90 years
- Gender
- Both males and females
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 seroton...
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 120 is planned, based on power analysis subject to modification after the first 20 participants complete the initial 3 month treatment period.
Tracking Information
- NCT #
- NCT04421573
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Kenneth D Reeves, M.D. Dr. Dean Reeves Clinic