Clinical Trial

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

Not Yet Recruiting Phase 3
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Summary
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-03-04; most recent amendment 2026-02-26.
Trial Details
NCT Number NCT05279937
Lead Sponsor Tulane University
Conditions Ehlers-Danlos Syndrome, Low Back Pain, Sacroiliac Instability
Enrollment 40 participants
Start Date 2026-06
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-03-02