Cervical Plexus Hydrodissection With D5W for PTSD

NCT ID: NCT04421573

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2027-10-01

Brief Summary

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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

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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

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized open-label crossover study comparing BHDCP with D5W versus a waiting period in which usual care is allowed.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

BCPHD with D5W

Intervention Type PROCEDURE

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

All helpful treatment methods already underway are continued. Other new treatment methods are discouraged.

Group Type ACTIVE_COMPARATOR

Waiting period with usual care

Intervention Type PROCEDURE

Same as previous group description

Interventions

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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.

Intervention Type PROCEDURE

Waiting period with usual care

Same as previous group description

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paul Johnson, D.O.

UNKNOWN

Sponsor Role collaborator

Eric Phillippi, M.D.

UNKNOWN

Sponsor Role collaborator

Ryan Wood, N.D.

UNKNOWN

Sponsor Role collaborator

Danesh Mazloomdoost

UNKNOWN

Sponsor Role collaborator

Dr. Dean Reeves Clinic

OTHER

Sponsor Role lead

Responsible Party

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Dr. Dean Reeves

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth D Reeves, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dr. Dean Reeves Clinic

Locations

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Danesh Mazloomdoost

Lexington, Kentucky, United States

Site Status RECRUITING

Paul W. Johnson, D.O., Clinic.

Portland, Oregon, United States

Site Status RECRUITING

NW Regen

Tigard, Oregon, United States

Site Status RECRUITING

Eric Phillippi M.D. Clinic

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kenneth D Reeves, M.D.

Role: CONTACT

9133621600

Kenneth D Reeves, M.D.

Role: CONTACT

9133621600

Facility Contacts

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Danesh Mazloomdoost, MD

Role: primary

859-275-4878

Paul W. Johnson, D.O.

Role: primary

Ryan R Wood, D.C., N.D.

Role: primary

Eric Phillippi, M.D.

Role: primary

References

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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. Erratum In: JAMA Psychiatry. 2020 Feb 1;77(2):218. doi: 10.1001/jamapsychiatry.2019.4511. JAMA Psychiatry. 2020 Sep 1;77(9):982. doi: 10.1001/jamapsychiatry.2020.1829.

Reference Type BACKGROUND
PMID: 31693083 (View on PubMed)

Other Identifiers

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DextrosePTSD1

Identifier Type: -

Identifier Source: org_study_id

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