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NOT YET RECRUITING
NCT05279937
PHASE3

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

Sponsor: Tulane University

View on ClinicalTrials.gov

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.

Official title: The Use of Ultrasound-Guided Dextrose Prolotherapy in Low Back Pain in Patients With Hypermobile-Type, Ehlers-Danlos Syndrome

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-06

Completion Date

2027-06

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

DRUG

Dextrose 50% Intravenous Solution

5mL of 50% Dextrose + 5mL of 1% Lidocaine (Prolotherapy).

DRUG

Lidocaine 1% Injectable Solution

10mL of 1% Lidocaine (Control)

Locations (1)

Tulane Hospital and Clinics

New Orleans, Louisiana, United States