Dextrose Injection for PTSD
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dr. Dean Reeves Clinic
Must not be taking: Narcotics
Disqualifiers: Schizophrenia, Bipolar, Borderline, others
No Placebo Group
Approved in 2 Jurisdictions
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.12345
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.
See 18 more
Trial 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 (Other)
- Waiting period with usual care (Other)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: BCPHD-D5W with usual careExperimental Treatment1 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 careActive Control1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Eric Phillippi M.D. ClinicMadison, WI
Paul W. Johnson, D.O., Clinic.Portland, OR
Drs. David & Jannice Bowler, Inc.: Bowler Medical ClinicVictoria, Canada
Hawaii Center for Regenerative MedicineHilo, HI
More Trial Locations
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Who Is Running the Clinical Trial?
Dr. Dean Reeves ClinicLead Sponsor
Francois Louw, M.DCollaborator
Paul Johnson, D.O. Asserted to be a recognized organizationCollaborator
Jannice Bowler, M.D.Collaborator
Stanley Lam, M.D.Collaborator
Ryan Wood, N.D.Collaborator
Smigel, Liza, M.D.Collaborator
Paul Johnson, D.O.Collaborator
Eric Phillippi, M.D.Collaborator
References
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]Deep nerve hydrodissection uses fluid injection under pressure to purposely separate nerves from areas of suspected fascial compression, which are increasingly viewed as potential perpetuating factors in recalcitrant neuropathic pain/complex regional pain. The usage of 5% dextrose water (D5W) as a primary injectate for hydrodissection, with or without low dose anesthetic, could limit anesthetic-related toxicity. An analgesic effect of 5% dextrose water (D5W) upon perineural injection in patients with chronic neuropathic pain has recently been described. Here we describe ultrasound-guided methods for hydrodissection of deep nerve structures in the upper torso, including the stellate ganglion, brachial plexus, cervical nerve roots, and paravertebral spaces. We retrospectively reviewed the outcomes of 100 hydrodissection treatments in 26 consecutive cases with a neuropathic pain duration of 16 ± 12.2 months and the mean Numeric Pain Rating Scale (NPRS) 0-10 pain level of 8.3 ± 1.3. The mean percentage of analgesia during each treatment session involving D5W injection without anesthetic was 88.1% ± 9.8%. The pretreatment Numeric Pain Rating Scale score of 8.3 ± 1.3 improved to 1.9 ± 0.9 at 2 months after the last treatment. Patients received 3.8 ± 2.6 treatments over 9.7 ± 7.8 months from the first treatment to the 2-month posttreatment follow-up. Pain improvement exceeded 50% in all cases and 75% in half. Our results confirm the analgesic effect of D5W injection and suggest that hydrodissection using D5W provides cumulative pain reduction.
Dextrose 5% in water: fluid medium for maintaining electrical stimulation of peripheral nerves during stimulating catheter placement. [2013]It is well documented that a higher electrical current is required to elicit a motor response following a normal saline (NS) injection during the placement of stimulating catheters for peripheral nerve block. We present three cases of continuous brachial plexus catheter placement in which Dextrose 5% in water (D5W) was used to dilate the perineural space instead of NS. Three brachial plexus blocks (two interscalene and one axillary) were performed in three different patients for pain relief. In each case, an insulated needle was advanced towards the brachial plexus. A corresponding motor response was elicited with a current less than 0.5 mA after needle repositioning. A stimulating catheter was advanced with ease after 3-5 ml of D5W was injected to dilate the perineural space. A corresponding motor response was maintained when the current applied to the stimulating catheter was less than 0.5 mA. Local anesthetic was then injected and the motor response immediately ceased. All blocks were successful and provided excellent pain relief with the continuous infusion of local anesthetics.
Analgesic Effect and Potential Cumulative Benefit from Caudal Epidural D5W in Consecutive Participants with Chronic Low-Back and Buttock/Leg Pain. [2021]Objectives: Chronic low-back pain (CLBP) participants in a prior controlled study reported short-term pain relief after caudal epidural injection of 5% dextrose (D5W). This study assessed whether repeated caudal epidural injections of D5W results in serial short-term diminution of CLBP and progressive long-term decrease in pain and disability. Design: Prospective uncontrolled study. Settings/Location: Outpatient pain clinic. Subjects: Adults with CLBP with radiation to gluteal or leg areas. Interventions: Caudal epidural injection of 10 mL of D5W (without anesthetic) every 2 weeks for four treatments and then as needed for 1 year. Outcome measures: Numerical Rating Scale (NRS, pain, 0-10 points), Oswestry Disability Index (ODI, disability, %), and fraction of participants with ≥50% reduction in NRS score. Analysis by intention to treat. Results: Participants (n = 32, 55 ± 9.8 years old, nine female) had moderate-to-severe CLBP (6.5 ± 1.2 NRS points) for 11.1 ± 10.8 years. They received 5.5 ± 2.9 caudal D5W injections through 12 months of follow-up. The data capture rate for analysis was 94% at 12 months for NRS and ODI outcome measures, with 6% carried forward by intention to treat. A consistent pattern of analgesia was demonstrated after D5W injection. Compared with baseline status, NRS and ODI scores improved by 3.4 ± 2.3 (52%) and 18.2 ± 16.4% (42%) points, respectively. The fraction of participants with 50% reduction in NRS-based pain was 21/32 (66%). Conclusion: Epidural D5W injection, in the absence of anesthetic, resulted in consistent postinjection analgesia and clinically significant improvement in pain and disability through 12 months for most participants. The consistent pattern postinjection analgesia suggests a potential sensorineural effect of dextrose on neurogenic pain.
Effect on neurostimulation of injectates used for perineural space expansion before placement of a stimulating catheter: normal saline versus dextrose 5% in water. [2019]We clinically assessed the electrophysiologic effect of dextrose 5% in water (D5W) and of normal saline (NS) used for expansion of the perineural space before placing a stimulating catheter. We questioned if higher current was required with NS but not with D5W, as has been observed experimentally.
Short Term Analgesic Effects of 5% Dextrose Epidural Injections for Chronic Low Back Pain: A Randomized Controlled Trial. [2020]Hypertonic dextrose injection (prolotherapy) is reported to reduce pain including non-surgical chronic low back pain (CLBP), and subcutaneous injection of 5% dextrose is reported to reduce neurogenic pain, hyperalgesia and allodynia. The mechanism in both cases is unclear, though a direct effect of dextrose on neurogenic pain has been proposed. This study assessed the short-term analgesic effects of epidural 5% dextrose injection compared with saline for non-surgical CLBP.