Dextrose Injection for PTSD

Recruiting at 9 trial locations

Overseen By Clare R Solso, R.N.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Dean Reeves Clinic

Must not be taking: Narcotics

Disqualifiers: Schizophrenia, Bipolar, Borderline, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for PTSD, a condition that affects mental well-being and daily life. Researchers are examining how dextrose injections (BCPHD with D5W) might reduce symptoms like anxiety and depression in people with PTSD. Participants will be divided into two groups: one receiving dextrose injections and the other continuing with their usual care. Individuals who have tried at least two medications and two other treatments for PTSD and have experienced symptoms for more than a year might be suitable candidates. This trial is available for those living near specific locations in Canada, the U.S., and Hong Kong. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment approach.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must not be taking daily narcotics to participate.

What prior data suggests that dextrose injection is safe for PTSD patients?

Research has shown that cervical plexus hydrodissection with D5W (a solution of 5% sugar in water) may help manage PTSD symptoms such as anxiety and depression. Earlier studies found this treatment promising in reducing pain by gently separating nerves from nearby tissues.

While detailed safety information for PTSD patients remains limited, this method is generally considered safe in similar contexts. Sugar water injections have been used for other health issues without major safety problems reported. This suggests the treatment is likely safe for most people, though individual experiences can vary. Discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care options for PTSD, which often include medications like SSRIs or cognitive behavioral therapy, the new BCPHD-D5W treatment uses a unique approach by incorporating bilateral cervical plexus hydrodissection with dextrose (D5W). This method targets the neck area, possibly offering a novel way to alleviate symptoms by addressing nerve inflammation directly. Researchers are excited about this treatment because it could provide relief much faster than traditional methods, potentially offering benefits within weeks rather than months.

What evidence suggests that dextrose injection might be an effective treatment for PTSD?

Research has shown that dextrose injections, particularly using D5W (dextrose 5% in water), may benefit people with PTSD. In this trial, some participants will receive BCPHD-D5W alongside usual care, which includes bilateral cervical plexus hydrodissection with D5W at specified intervals. Studies have found that this treatment can reduce symptoms like anxiety, brain fog, and depression by calming the nervous system. Additionally, dextrose injections have proven effective for chronic pain, suggesting they might also alleviate discomfort related to PTSD. Although more research is needed, early results are promising for improving life quality for those with PTSD. ^{1 2 3 4 6}

Who Is on the Research Team?

Kenneth D Reeves, M.D.

Principal Investigator

Dr. Dean Reeves Clinic

Are You a Good Fit for This Trial?

This trial is for adults with PTSD who drink less than three alcoholic drinks daily, don't take narcotics, and aren't in other PTSD studies. Participants need reliable transport, computer skills, no life-threatening illness or major stressors that could affect the study. They must live near specified locations in Canada or Hong Kong, provide contact details, commit to a year-long study including possible usual care for 3 months, have had symptoms over a year with moderate pain levels at most.

Inclusion Criteria

Must be comfortable with computers

I have tried at least 2 non-drug treatments for PTSD.

I can provide 2 emails and 2 phone numbers for contact.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Bilateral cervical plexus hydrodissection with D5W at 0, 2, 4, and 8 weeks

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• BCPHD with D5W
• Waiting period with usual care

Trial Overview

The trial tests cervical plexus hydrodissection with D5W (a dextrose solution) against a waiting period with usual care for PTSD patients. It aims to see if this injection can reduce anxiety and improve mental health symptoms compared to standard treatments after an initial delay.

How Is the Trial Designed?

Group I: BCPHD-D5W with usual care Experimental Treatment 1 Intervention

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 II: Waiting period with usual care Active Control 1 Intervention

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

BCPHD with D5W is already approved in United States, European Union for the following indications:

Approved in United States as Cervical Plexus Hydrodissection With D5W for:

• Chronic pain
• Anxiety
• Depression
• PTSD (off-label)

Approved in European Union as Cervical Plexus Hydrodissection With D5W for:

• Chronic pain
• Anxiety
• Depression
• PTSD (off-label)

Who Is Running the Clinical Trial?

Dr. Dean Reeves Clinic

Lead Sponsor

Trials

5

Recruited

220+

Francois Louw, M.D

Collaborator

Trials

1

Recruited

20+

Paul Johnson, D.O. Asserted to be a recognized organization

Collaborator

Trials

1

Recruited

20+

Jannice Bowler, M.D.

Collaborator

Trials

1

Recruited

20+

Stanley Lam, M.D.

Collaborator

Trials

1

Recruited

20+

Ryan Wood, N.D.

Collaborator

Trials

1

Recruited

20+

Smigel, Liza, M.D.

Collaborator

Trials

2

Recruited

60+

Paul Johnson, D.O.

Collaborator

Trials

1

Recruited

20+

Eric Phillippi, M.D.

Collaborator

Trials

1

Recruited

20+

Danesh Mazloomdoost

Collaborator

Published Research Related to This Trial

Using Dextrose 5% in water (D5W) instead of normal saline (NS) for dilating the perineural space during brachial plexus catheter placement allowed for effective motor response elicitation at lower electrical currents (less than 0.5 mA).

All three cases of brachial plexus blocks (two interscalene and one axillary) were successful, providing excellent pain relief with continuous local anesthetic infusion, demonstrating the efficacy of D5W in this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dextrose 5% in water: fluid medium for maintaining electrical stimulation of peripheral nerves during stimulating catheter placement. Tsui, BC., Kropelin, B., Ganapathy, S., et al.[2013]

A study involving 35 adults with chronic low back pain showed that a single epidural injection of 5% dextrose significantly reduced pain more effectively than saline, with notable improvements observed at 15 minutes, 2 hours, 4 hours, and 48 hours post-injection.

At 4 hours, 84% of participants receiving dextrose reported at least a 50% reduction in pain, compared to only 19% in the saline group, suggesting a potential neurogenic mechanism of action for dextrose in pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short Term Analgesic Effects of 5% Dextrose Epidural Injections for Chronic Low Back Pain: A Randomized Controlled Trial. Maniquis-Smigel, L., Dean Reeves, K., Jeffrey Rosen, H., et al.[2020]

In a study involving 50 patients undergoing total knee replacement, it was found that using normal saline (NS) required a higher minimal intensity of stimulation (MIS) for nerve electrostimulation compared to dextrose 5% in water (D5W) during catheter placement.

This suggests that D5W may be more effective for nerve localization in peripheral nerve blocks, as it allows for lower stimulation currents, potentially improving the ease and safety of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect on neurostimulation of injectates used for perineural space expansion before placement of a stimulating catheter: normal saline versus dextrose 5% in water. Pham Dang, C., Lelong, A., Guilley, J., et al.[2019]

Deep nerve hydrodissection using 5% dextrose water (D5W) has shown significant analgesic effects in patients with chronic neuropathic pain, with an average pain reduction of 88.1% during treatment sessions.

In a study of 26 patients with a mean pain duration of 16 months, the Numeric Pain Rating Scale improved from 8.3 to 1.9 after treatment, indicating that D5W hydrodissection can provide substantial and cumulative pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transition from Deep Regional Blocks toward Deep Nerve Hydrodissection in the Upper Body and Torso: Method Description and Results from a Retrospective Chart Review of the Analgesic Effect of 5% Dextrose Water as the Primary Hydrodissection Injectate to Enhance Safety. Lam, SKH., Reeves, KD., Cheng, AL.[2023]

In a study of 32 adults with chronic low-back pain, repeated caudal epidural injections of 5% dextrose (D5W) led to significant short-term pain relief and long-term improvements in pain and disability over 12 months.

Participants experienced an average pain reduction of 52% and a 42% decrease in disability, with 66% of participants achieving at least a 50% reduction in pain scores, suggesting a potential beneficial effect of dextrose on neurogenic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic Effect and Potential Cumulative Benefit from Caudal Epidural D5W in Consecutive Participants with Chronic Low-Back and Buttock/Leg Pain. Maniquis-Smigel, L., Reeves, KD., Rosen, HJ., et al.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04421573?tab=history&a=23

Cervical Plexus Hydrodissection With D5W for PTSD

... water (D5W), has performed well empirically in the treatment of post-traumatic stress disorder. No lidocaine is utilized, which allows for avoidance of ...

2.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT04421573/cervical-plexus-hydrodissection-with-d5w-for-ptsd

Cervical Plexus Hydrodissection With D5W for PTSD

This small study is designed as a feasibility study with study acceptance rate, protocol adherence, and satisfaction as primary outcomes.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8988854/

A Novel Somatic Treatment for Post-traumatic Stress Disorder

This is most commonly performed using dextrose 5% in water (D5W), as, in addition to a mechanical effect, it is thought to have an ameliorative ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04421573?tab=history&a=22

Cervical Plexus Hydrodissection With D5W for PTSD

An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

5.

withpower.com

withpower.com/trial/phase-10-2021-2e04b

Dextrose Injection for PTSD

Deep nerve hydrodissection using 5% dextrose water (D5W) has shown significant analgesic effects in patients with chronic neuropathic pain, with an average pain ...

6.

ctv.veeva.com

ctv.veeva.com/study/cervical-plexus-hydrodissection-with-d5w-for-ptsd

Cervical Plexus Hydrodissection With D5W for PTSD

This randomized trial will compare dextrose injection with a delayed/usual treatment control. Full description. PTSD is a well-recognized ...