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The Ultrasound-Guided Dextrose Prolotherapy in Ehlers-Danlos Syndrome Patients

StatusWithdrawn
PhasePhase 3
Started
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Record History

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  1. Withdrawn before enrolling Sponsor's reason: Study did not receive funding. Show 4 more changesShow less
    • Enrollment target: estimated 40 to confirmed 0
    • Primary completion date changed from estimate of Dec 2027 to Oct 5, 2026
    • Start date changed from estimate of Dec 2026 to Oct 5, 2026
    • Study sites: 1 to 0
  2. Start date: Jun 2026 to Dec 2026
    • Primary and study completion pushed from Jun 2027 to Dec 2027
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 3 entries
  3. Start date: Dec 2025 to Jun 2026
    • Primary and study completion dates: Dec 2026 to Jun 2027
    v9
  4. Primary and study completion dates: Feb 2026 to Dec 2026
    • Start date: Feb 2025 to Dec 2025
    v8
  5. Start date: Sep 2024 to Feb 2025
    • Primary and study completion dates: Sep 2025 to Feb 2026
    • Site contact updated
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Mar 2024 to Sep 2025
    • Start date: Aug 1, 2023 to Sep 2024
    • Study completion date: Sep 2024 to Sep 2025
    • Site contact updated
    v6
  2. Re-verified, no change to tracked fieldsv5
  3. Start date: Oct 2022 to Aug 1, 2023v4
  4. Start date: May 2022 to Oct 2022v3
  5. Start date: Mar 2022 to May 2022v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
1. Specific Aim: To show the safety and efficacy of prolotherapy injection for chronic sacroiliac and myofascial lumbar pain while standardizing an ultrasound guided injection technique 2. Specific Aim: To demonstrate that dextrose prolotherapy subjectively decreases lumbar back pain (LBP) associated with chronic sacroiliac (SI) and myofascial lumbar back pain/injury in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS). 3. Specific Aim: To use ultrasound (US) guidance to identify SI and myofascial lumbar back pain/injury for targeted dextrose prolotherapy treatment and to provide objective measures of decreasing inflammation via Power Doppler and ligament repair. 4. Specific Aim: To determine if US-guided dextrose prolotherapy decreases the direct costs of care for chronic LBP in contrast to conventional therapies by reducing return visits, specialty referrals, physical therapy, medications, and unnecessary procedures.
Trial Details
NCT Number NCT05279937
Lead Sponsor Tulane University
Conditions
(from sponsor)		 Ehlers-Danlos Syndrome, Low Back Pain, Sacroiliac Instability
Related terms Ehlers-Danlos Syndrome, Low Back Pain
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov