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

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Tulane University
Study ID
NCT05279937
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dextrose 50% Intravenous Solution — DRUG
    5mL of 50% Dextrose + 5mL of 1% Lidocaine (Prolotherapy).
  • Lidocaine 1% Injectable Solution — DRUG
    10mL of 1% Lidocaine (Control)

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Prolotherapy
    5mL of 50% Dextrose + 5mL of 1% Lidocaine (Prolotherapy).
  • Active Comparator: Control
    10mL of 1% Lidocaine (Control)

Primary Outcome Measure

Measuring the functionality of the lumbar spine by using Oswestry Low Back Pain Disability Questionnaire in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS) [ Time Frame: 12 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tulane Hospital and ClinicsNew OrleansLouisiana70118
Orsula Staka, MBA
[email protected]
628-800-4354
Jacques Courseault, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Orleans, LA

By research site
Tulane Hospital and Clinics· New Orleans, LA

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