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

NCT05279937 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

  • Ehlers-Danlos Syndrome
  • Low Back Pain
  • Sacroiliac Instability

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)

Sponsors & Collaborators

  • Tulane University

    lead OTHER

Principal Investigators

  • Jacques Courseault, MD · Tulane University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05279937 on ClinicalTrials.gov