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Active, Not Recruiting

NCT Number: NCT04421573

Cervical Plexus Hydrodissection With D5W for PTSD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danesh Mazloomdoost, Lexington, Kentucky, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BCPHD with D5W

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

Procedure

Same as previous group description

Primary outcomes

  1. Consent rate

    Time frame: 3 months

    Percentage consent rate for qualifying participants

  2. Data Capture rate

    Time frame: 3 months

    Percentage data capture

  3. Satisfaction rating

    Time frame: 3 months

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

Secondary outcomes

  1. PCL-C Score

    Time frame: 3 months

    Improvement (reduction) in PTSD check list for civilians

  2. HADS scale

    Time frame: 3 months

    Improvement in the Hospital Anxiety and Depression Scale

  3. EuroQOL 0-100

    Time frame: 3 months

    0-100 rating of quality of life

  4. Qualitative interview

    Time frame: Nine to twelve months after receiving first D5W treatment for PTSD

    Qualitative interview

Sponsors and collaborators

Lead sponsor

Dr. Dean Reeves Clinic

Other

Collaborators

  • Danesh Mazloomdoost
  • Eric Phillippi, M.D.
  • Paul Johnson, D.O.
  • Ryan Wood, N.D.

Registry information

Official study title

Cervical Plexus Hydrodissection With D5W for PTSD Versus Delayed Treatment/Usual Care

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2020
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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