NCT04421573

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
17mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jul 2023Oct 2027

First Submitted

Initial submission to the registry

June 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
3.1 years until next milestone

Study Start

First participant enrolled

July 10, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

3.2 years

First QC Date

June 4, 2020

Last Update Submit

January 24, 2026

Conditions

PTSD

Keywords

DextroseHydrodissectionCervical Plexus

Outcome Measures

Primary Outcomes (3)

  • Consent rate

    Percentage consent rate for qualifying participants

    3 months

  • Data Capture rate

    Percentage data capture

    3 months

  • Satisfaction rating

    Satisfaction with treatment outcome as measured by a 0-10 Numerical Rating Scale (NRS)

    3 months

Secondary Outcomes (3)

  • PCL-C Score

    3 months

  • HADS scale

    3 months

  • EuroQOL 0-100

    3 months

Study Arms (2)

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.

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.

Procedure: Waiting period with usual care

Interventions

BCPHD with D5WPROCEDURE

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.

BCPHD-D5W with usual care
Waiting period with usual carePROCEDURE

Same as previous group description

Waiting period with usual care

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Danesh Mazloomdoost

Lexington, Kentucky, 40509, United States

RECRUITING

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

Portland, Oregon, 87213, United States

RECRUITING

NW Regen

Tigard, Oregon, 97224, United States

RECRUITING

Eric Phillippi M.D. Clinic

Madison, Wisconsin, 53719, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31693083BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Kenneth D Reeves, M.D.

    Dr. Dean Reeves Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth D Reeves, M.D.

CONTACT

9133621600DeanReevesMD@gmail.com

Kenneth D Reeves, M.D.

CONTACT

9133621600ReevesOffice@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized open-label crossover study comparing BHDCP with D5W versus a waiting period in which usual care is allowed.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 9, 2020

Study Start

July 10, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations

US(4)