PTSDNCT04421573
Cervical Plexus Hydrodissection With D5W for PTSD
A study testing BCPHD with D5W in people with PTSD, run by Dr. Dean Reeves Clinic at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- PTSD
- What is being tested?
- BCPHD with D5W
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Jul 2023to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Danesh Mazloomdoost
Lexington, Kentucky, 40509
Eric Phillippi M.D. Clinic
Madison, Wisconsin, 53719
Paul W. Johnson, D.O., Clinic.
Portland, Oregon, 87213
NW Regen
Tigard, Oregon, 97224
About this study
Official title: 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.
Read the 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.
- Conditions
- PTSD
- Being tested
- BCPHD with D5W, Waiting period with usual care
- Keywords
- Dextrose, Hydrodissection, Cervical Plexus
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCPHD with D5WProcedure or surgery
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 careProcedure or surgery
Same as previous group description
| Study group | Role | What they receive |
|---|---|---|
| BCPHD-D5W with usual care | Experimental | 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. Receives: Procedure: BCPHD with D5W |
| Waiting period with usual care | Active comparator | All helpful treatment methods already underway are continued. Other new treatment methods are discouraged. Receives: Procedure: Waiting period with usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent rate
Percentage consent rate for qualifying participants
Measured: 3 months
Data Capture rate
Percentage data capture
Measured: 3 months
Satisfaction rating
Satisfaction with treatment outcome as measured by a 0-10 Numerical Rating Scale (NRS)
Measured: 3 months
Secondary outcomes (4)
PCL-C Score
Improvement (reduction) in PTSD check list for civilians
Measured: 3 months
HADS scale
Improvement in the Hospital Anxiety and Depression Scale
Measured: 3 months
EuroQOL 0-100
0-100 rating of quality of life
Measured: 3 months
Qualitative interview
Qualitative interview
Measured: Nine to twelve months after receiving first D5W treatment for PTSD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start10 Jul 2023
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Dean Reeves Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Paul Johnson, D.O., Eric Phillippi, M.D., Ryan Wood, N.D., Danesh Mazloomdoost
- Responsible party
- Principal investigator, Dr. Dean Reeves, Dr. Dean Reeves Clinic
- Investigators
- Kenneth D Reeves, M.D., Principal investigator, Dr. Dean Reeves Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421573
- Sponsor's protocol ID
- DextrosePTSD1
- Status last verified
- Jul 2026
- First submitted
- 4 Jun 2020
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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 Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):130-138. doi: 10.1001/jamapsychiatry.2019.3474.
PubMed 31693083
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Plexus Hydrodissection With D5W for PTSD Versus Delayed Treatment/Usual Care
- ClinicalTrials.gov ID
- NCT04421573
- Acronym / sponsor ID
- DextrosePTSD1
- Conditions
- PTSD
- Keywords
- Dextrose, Hydrodissection, Cervical Plexus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dr. Dean Reeves ClinicUniversity, hospital or other
- Collaborators
- Paul Johnson, D.O., Eric Phillippi, M.D., Ryan Wood, N.D., Danesh Mazloomdoost
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized open-label crossover study comparing BHDCP with D5W versus a waiting period in which usual care is allowed.
| Arm | Type | Receives |
|---|---|---|
| BCPHD-D5W with usual care | Experimental | Procedure: BCPHD with D5WBilateral 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. |
| Waiting period with usual care | Active comparator | Procedure: Waiting period with usual careAll helpful treatment methods already underway are continued. Other new treatment methods are discouraged. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCPHD with D5WD5W 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. | Procedure or surgery | BCPHD-D5W with usual care |
| Waiting period with usual careSame as previous group description | Procedure or surgery | Waiting period with usual care |
Primary outcome
Consent rate
Time frame: 3 months
Percentage consent rate for qualifying participants
Data Capture rate
Time frame: 3 months
Percentage data capture
Satisfaction rating
Time frame: 3 months
Satisfaction with treatment outcome as measured by a 0-10 Numerical Rating Scale (NRS)
4 secondary outcomes
PCL-C Score
Time frame: 3 months
HADS scale
Time frame: 3 months
EuroQOL 0-100
Time frame: 3 months
Qualitative interview
Time frame: Nine to twelve months after receiving first D5W treatment for PTSD
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 31693083Rae 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 Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):130-138. doi: 10.1001/jamapsychiatry.2019.3474.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth D Reeves, M.D. principal investigator
Dr. Dean Reeves Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCPHD with D5W in people with PTSD, run by Dr. Dean Reeves Clinic at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent rate (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04421573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.