Dextrose Injection for PTSD

Recruiting at 8 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

Trial Summary

What is the purpose of this trial?

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.

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.

How is the treatment BCPHD with D5W different from other PTSD treatments?

BCPHD with D5W is unique because it involves injecting a solution of 5% dextrose in water to separate nerves from surrounding tissues, potentially reducing pain by addressing nerve compression. This method, known as hydrodissection, is different from typical PTSD treatments that often focus on medication or therapy, as it directly targets nerve-related pain. ^{1 2 3 4 5}

Research Team

Kenneth D Reeves, M.D.

Principal Investigator

Dr. Dean Reeves Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Dextrose 5% in water: fluid medium for maintaining electrical stimulation of peripheral nerves during stimulating catheter placement. [2013]

3. United States 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. [2021]

4. England 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. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Short Term Analgesic Effects of 5% Dextrose Epidural Injections for Chronic Low Back Pain: A Randomized Controlled Trial. [2020]