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Cervical Plexus Hydrodissection With D5W for PTSD

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Secondary endpoints: 3 to 4v34
  2. Notable Primary completion pushed from Oct 1, 2026 to Oct 1, 2027
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 4 of 4 sites
    v33
  3. Minor Secondary endpoints: 2 to 3
    • Study sites revised (4)
    • Eligibility criteria shortened, about 5 words
    v32
  4. Minor Site contacts updated at 1 of 4 sitesv31
  5. Minor Study sites revised (4)
    • Collaborators: 6 to 4
    v30
Show 28 earlier versionsHide 28 earlier versions
  1. Minor Study sites: 5 to 4v29
  2. Minor Study sites: 7 to 5
    • Collaborators: 7 to 6
    v28
  3. Minor 2 versions Re-verified since Feb 4, 2025, no change to tracked fieldsv26-v27
  4. Minor Study sites: 5 to 7
    • Collaborators: 5 to 7
    v25
  5. Minor Publications: details revised at 1 of 1 entryv24
  6. Minor Eligibility criteria expanded, about 4 wordsv23
  7. Minor Study sites: 3 to 5
    • Collaborators: 4 to 5
    v22
  8. Minor Re-verified, no change to tracked fieldsv21
  9. Notable Primary endpoints: 2 to 3v20 Show 4 more changesShow less
    • Secondary endpoints revised (2)
    • Study description expanded, about 16 words
    • Study sites revised (3)
    • Collaborators: 3 to 4
  10. Minor Re-verified, no change to tracked fieldsv19
  11. Minor Site contacts updated at 1 of 3 sitesv18
  12. Minor Eligibility criteria shortened, about 58 wordsv17
  13. Notable Trial status: Withdrawn to Recruiting
    • Enrollment target: 0 to 24
    • Start date changed from estimate of Oct 1, 2023 to Jul 10, 2023
    • Site details revised at 3 of 3 sites
    v16
  14. Notable Primary completion date: Mar 15, 2020 to Oct 1, 2026v15 Show 7 more changesShow less
    • Start date: Nov 1, 2019 to Oct 1, 2023
    • Study sites: 1 to 3
    • Study completion date: Mar 15, 2020 to Oct 1, 2027
    • Eligibility criteria expanded, about 105 words
    • Secondary endpoints: 6 to 2
    • Study description shortened, about 15 words
    • Collaborators expanded, about 9 words
  15. Stopped Trial status: Not Yet Recruiting to Withdrawn Sponsor's reason: Covid and lack of funding. See published case report. Another site is being sought.v14 Show 5 more changesShow less
    • Enrollment target: estimated 120 to confirmed 0
    • Primary completion date changed from estimate of Aug 1, 2028 to Mar 15, 2020
    • Study completion date changed from estimate of Aug 1, 2029 to Mar 15, 2020
    • Start date changed from estimate of Nov 1, 2021 to Nov 1, 2019
    • Site contact updated
  16. Notable Primary completion date: Jun 7, 2027 to Aug 1, 2028v13 Show 4 more changesShow less
    • Start date: Jun 7, 2021 to Nov 1, 2021
    • Trial status: Recruiting to Not Yet Recruiting
    • Study completion date: Jun 7, 2028 to Aug 1, 2029
    • Site details revised
  17. Notable Primary endpoints revised (2)
    • Secondary endpoints: 5 to 6
    v12
  18. Notable Enrollment target: 20 to 120v11 Show 8 more changesShow less
    • Primary completion date: Jul 3, 2025 to Jun 7, 2027
    • Start date: Oct 6, 2020 to Jun 7, 2021
    • Primary endpoints: 3 to 2
    • Study completion date: Mar 3, 2026 to Jun 7, 2028
    • Interventions: Bilateral cervical plexus hydrodissetion with D5W (Procedure), Delayed/usual care treament (Procedure) to BCPHD with D5W (Procedure), Waiting period with usual care (Procedure)
    • Secondary endpoints: 4 to 5
    • Study description shortened, about 28 words
    • Study title shortened, about 7 words
  19. Notable Primary completion date: Jul 3, 2021 to Jul 3, 2025v10 Show 6 more changesShow less
    • Start date: Jul 3, 2020 to Oct 6, 2020
    • Study completion date: Mar 3, 2024 to Mar 3, 2026
    • Interventions: Bilateral cervical plexus hydrodissetion with D5W (Procedure), Bilateral sternocleidomastoid muscle injection with D5W (Procedure) to Bilateral cervical plexus hydrodissetion with D5W (Procedure), Delayed/usual care treament (Procedure)
    • Secondary endpoints: 6 to 4
    • Study description revised
    • Eligibility criteria expanded, about 4 words
  20. Minor Eligibility criteria revisedv9
  21. Minor Study completion date: Mar 3, 2022 to Mar 3, 2024
    • Study description shortened, about 7 words
    v8
  22. Notable Primary endpoints revised (3)v7 Show 4 more changesShow less
    • Eligibility criteria shortened, about 29 words
    • Secondary endpoints revised (6)
    • Study description shortened, about 49 words
    • Study title expanded, about 3 words
  23. Minor Eligibility criteria shortened, about 4 wordsv6
  24. Notable Enrollment target: 96 to 20
    • Study title expanded, about 3 words
    v5
  25. Minor Secondary endpoints: 3 to 6v4
  26. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 7 more changesShow less
    • Primary endpoints revised (3)
    • Primary completion date: Jul 1, 2021 to Jul 3, 2021
    • Study completion date: Jul 1, 2022 to Mar 3, 2022
    • Start date changed from estimate of Jul 1, 2020 to Jul 3, 2020
    • Secondary endpoints: 4 to 3
    • Site details revised
    • Eligibility criteria shortened, about 2 words
  27. Minor Interventions: Bilateral hydrodissection of the cervical plexus (Procedure), Sham Procedure (Procedure) to Bilateral cervical plexus hydrodissetion with D5W (Procedure), Bilateral sternocleidomastoid muscle injection with D5W (Procedure)
    • Secondary endpoints: details revised at 1 of 4 entries
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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 Details
NCT Number NCT04421573
Lead Sponsor Dr. Dean Reeves Clinic
Collaborators: Paul Johnson, D.O., Eric Phillippi, M.D., Ryan Wood, N.D., Danesh Mazloomdoost
Conditions
(from sponsor)
PTSD
Related terms Stress Disorders, Post-Traumatic
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov