Cervical Plexus Hydrodissection With D5W for PTSD
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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. 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BCPHD-D5W with usual care Bilateral cervical plexus hydrodissection with D5W (BCPHD-D5W) at 0, 2, 4, 6 and 8 weeks. All helpful treatment methods already underway are continued. Other new treatment methods are discouraged. |
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.
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| Active Comparator: Waiting period with usual care All helpful treatment methods already underway are continued. Other new treatment methods are discouraged. |
Procedure: Waiting period with usual care
Same as previous group description
|
Outcome Measures
Primary Outcome Measures
- PCL-C Score [3 months]
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.
- Hospital Anxiety and Depression scale [3 months]
Measurement of symptoms of anxiety and depression. Range from 0 to 21. An improvement is a reduction in the HADS score.
Secondary Outcome Measures
- 0-10 Numerical Rating Scale (NRS) for Anxiety [3 months]
Anchors include "0 = none" and "10 = most severe imaginable". An improvement is a reduction in the NRS scale.
- 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for anxiety [3 months]
Anchors include "0 = no anxiety" and "10 = most severe imaginable". A 50% reduction in the 0-10 NRS is a clinically important outcome.
- Satisfaction with treatment outcome as measured by a 0-10 Numerical Rating Scale (NRS) [3 months]
Anchors include "0 = no satisfaction" and "10 = complete satisfaction"
- EuroQOL-5D-5L + C scale [3 months]
Measurement of general quality of life. Each question has a range from 1 to 5. An improvement is a reduction in score.
- 20 minute change in 0-10 NRS score for anxiety [20 minutes]
Change in anxiety score from baseline to 20 minutes post injection
- Satisfaction with comfort of procedure as measured by a 0-10 Numerical Rating Scale [3 months]
Anchors include "0 = Unsatisfied. Most painful procedure imaginable" and "10= Completely satisfied. No pain with procedure."
Eligibility Criteria
Criteria
Inclusion Criteria:
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U.S. veteran or first responder
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Score of 31 or more on the PCL-5 (Post traumatic stress disorder checklist)
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Not involved in another study of PTSD treatment
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Not planning to move out of the Kansas City area for 18 months or more
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Availability on Monday evenings
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Reliable transportation
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Within a 60 minute drive of Roeland Park, Kansas
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Willing to provide 2 email and 2 phone contact methods
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Willing to answer 20 minutes of questions multiple times over the course of a year
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Comfortable with computers
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Willing to be assigned to a control group for 8 weeks
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CAPS-5 Rating of greater than or equal to 26
Exclusion Criteria: None separate from inclusion criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr. Dean Reeves Clinic | Roeland Park | Kansas | United States | 66205 |
Sponsors and Collaborators
- Dr. Dean Reeves Clinic
Investigators
- Principal Investigator: Kenneth D Reeves, M.D., Dr. Dean Reeves Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DextrosePTSD1