drugset / Trial / NCT05279937

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

NCT05279937

Phase 3 Not yet recruiting 40 enrolled Tulane University
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2026-06
Primary completion
2027-06
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Dextrose Unknown 5 ml Other
Comparator Lidocaine Other / unclassified 5 ml Other
Comparator Lidocaine Other / unclassified 10 ml Other