- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04421573
Cervical Plexus Hydrodissection With D5W for PTSD
January 24, 2026 updated by: Dr. Dean Reeves, Dr. Dean Reeves Clinic
Cervical Plexus Hydrodissection With D5W for PTSD Versus Delayed Treatment/Usual Care
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
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.
Study Type
Interventional
Enrollment (Estimated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kenneth D Reeves, M.D.
- Phone Number: 9133621600
- Email: DeanReevesMD@gmail.com
Study Contact Backup
- Name: Kenneth D Reeves, M.D.
- Phone Number: 9133621600
- Email: ReevesOffice@gmail.com
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40509
- Recruiting
- Danesh Mazloomdoost
-
Contact:
- Danesh Mazloomdoost, MD
- Phone Number: 859-275-4878
- Email: drd@wellwardmed.com
-
-
Oregon
-
Portland, Oregon, United States, 87213
- Recruiting
- Paul W. Johnson, D.O., Clinic.
-
Contact:
- Paul W. Johnson, D.O.
- Email: paulwjohnsonDO@yahoo.com
-
Tigard, Oregon, United States, 97224
- Recruiting
- NW Regen
-
Contact:
- Ryan R Wood, D.C., N.D.
- Email: drwood@nwregen.com
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53719
- Recruiting
- Eric Phillippi M.D. Clinic
-
Contact:
- Eric Phillippi, M.D.
- Email: eric@medicalprocedures.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Portlland, OR, Madison, WI, or Lexington, KY
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Waiting period with usual care
All helpful treatment methods already underway are continued.
Other new treatment methods are discouraged.
|
Same as previous group description
|
|
Experimental: BCPHD-D5W with usual care
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Consent rate
Time Frame: 3 months
|
Percentage consent rate for qualifying participants
|
3 months
|
|
Data Capture rate
Time Frame: 3 months
|
Percentage data capture
|
3 months
|
|
Satisfaction rating
Time Frame: 3 months
|
Satisfaction with treatment outcome as measured by a 0-10 Numerical Rating Scale (NRS)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PCL-C Score
Time Frame: 3 months
|
Improvement (reduction) in PTSD check list for civilians
|
3 months
|
|
HADS scale
Time Frame: 3 months
|
Improvement in the Hospital Anxiety and Depression Scale
|
3 months
|
|
EuroQOL 0-100
Time Frame: 3 months
|
0-100 rating of quality of life
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost Efficiency
Time Frame: 0 to 52 weeks
|
Cost per improvement in PCL-C, HADS and EuroQOL
|
0 to 52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kenneth D Reeves, M.D., Dr. Dean Reeves Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 10, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2027
Study Registration Dates
First Submitted
June 4, 2020
First Submitted That Met QC Criteria
June 4, 2020
First Posted (Actual)
June 9, 2020
Study Record Updates
Last Update Posted (Actual)
January 27, 2026
Last Update Submitted That Met QC Criteria
January 24, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DextrosePTSD1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on PTSD
-
University of PittsburghCompletedPTSD | Non PTSDUnited States
-
COMPASS PathwaysNot yet recruitingPTSD | PTSD, Post Traumatic Stress Disorder | PTSD Symptoms | PTSD - Post Traumatic Stress Disorder
-
Valhalla Project NiagaraRecruiting
-
York UniversityRecruiting
-
VA Office of Research and DevelopmentCompleted
-
Tonix Pharmaceuticals, Inc.Withdrawn
-
University of Wisconsin, MadisonCompleted
-
University of PennsylvaniaUniversity of TexasCompleted
-
Johns Hopkins UniversitySchool of Biomedical Sciences, University of Otago, Dunedin, New Zealand; D...Completed
Clinical Trials on BCPHD with D5W
-
Shin Kong Wu Ho-Su Memorial HospitalRecruitingCarpal Tunnel Syndrome | Ultrasound | Carpal Tunnel Release | Dextrose | Nerve Hydrodissection TherapyTaiwan
-
US Neuropathy CentersEnrolling by invitation
-
Mast Therapeutics, Inc.Terminated
-
Tranzyme, Inc.CompletedDiabetes Mellitus | GastroparesisUnited States, Denmark, Norway, Sweden, United Kingdom, India
-
Tranzyme, Inc.CompletedDiabetes Mellitus | GastroparesisSweden, Denmark
-
Tranzyme, Inc.CompletedPostoperative IleusUnited States, India, Romania
-
Universidad Abierta InteramericanaUnknownSuperficial Radial Nerve LesionArgentina
-
Smigel, Liza, M.D.Completed
-
John A. SchirgerNational Institutes of Health (NIH)WithdrawnHeart Failure | Renal Insufficiency
-
Guy's and St Thomas' NHS Foundation TrustActive, not recruiting