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Ultrasound-Guided Dextrose Prolotherapy for Ehlers-Danlos Syndrome

This study is testing if ultrasound-guided injections of Dextrose 50% Intravenous Solution (prolotherapy) can help people with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS) who have chronic low back pain and sacroiliac (SI) instability. Researchers want to see if these injections are safe and effective at reducing pain and improving function. They will compare the effects of Dextrose 50% Intravenous Solution plus Lidocaine 1% Injectable Solution to just Lidocaine 1% Injectable Solution. The study aims to enroll 40 participants, aged 18 to 75, who have chronic low back pain related to SI dysfunction or myofascial lumbar pain and a diagnosis of hEDS. Success will be measured by changes in how well participants can perform daily activities, as assessed by a questionnaire after 12 months. The current status of this study is unclear.

Study design
This interventional study plans to enroll 40 participants. It compares two different injection treatments to understand their effects.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months to measure the functionality of their lumbar spine.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05279937

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

Not Yet Recruiting
PHASE3Ages 18–75InterventionalTreatment
Tulane University
~40 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:Dextrose 50% Intravenous SolutionLidocaine 1% Injectable Solution

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measuring the functionality of the lumbar spine by using Oswestry Low Back Pain Disability Questionnaire in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS)
Measured over 12 Months

Conditions

Ehlers-Danlos Syndrome
Low Back Pain
Sacroiliac Instability

Explore related trials

Ehlers-Danlos SyndromeLower Back PainSomatic dysfunction of sacroiliac joint

Where it's being run

1 sites across 1 states
Louisiana1

Study leadership

  • Jacques Courseault, MD · PRINCIPAL_INVESTIGATOR · Tulane University

Who to contact

Orsula Staka, MBA
[email protected]
628-800-4354
Email the study team

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Eligibility criteria

Inclusion

Men and women between the ages of 18-75
Subjects who resent to Tulane Institute of Sports Medicine and Tulane Lakeside with low back pain that is diagnosed as chronic (\>3 months) SI dysfunction or myofascial lumbar pain with a diagnosis of hEDS per The International Consortium on Ehlers-Danlos Syndrome and Related Disorders diagnostic criteria.
Diagnosis will include but not be limited to physical exam findings consistent with tenderness to palpation over the sacroiliac joint (SIJ) or posterior superior iliac crest, and upper outer quadrant of the gluteus maximus.
Diagnosis will also include US-guided tenderness to palpation of the thoracolumbar facial complex insertion into the posterior superior iliac spine (PSIS), SI, or gluteus maximus.
Further testing will include US evaluation using a General Electric Logiq E ultrasound machine to look for any evidence of structural abnormality or reactive hyperemia of the TLFC, LPSL, multifidus or gluteus maximus.

Exclusion

Patients \>75 and \< 18 years old.
Any patient with evidence of lumbar radiculopathy, acute lower back pain, pregnancy, prior lumbosacral surgery, opiate use within the last 6 months, steroid exposure within 6 weeks, NSAID exposure within 2 weeks.
Patients who are unwilling to stop taking or admit to receiving NSAIDs or any form of corticosteroids during the study.
Patients with a history of bleeding disorders, severe thrombocytopenia, immunodeficiency disorder, and hypersensitivity of local anesthetics of amide type will be excluded along with any patient who actively has systemic bacterial infection with fever, skin infection over the injection site, or takes anti-platelet/anti-coagulant medication.
Patients with comorbidities such as diabetes mellitus, rheumatoid arthritis, lupus, or any other condition that increases risk of infection may be excluded from the study pending severity and current treatment of their condition.
Patients receiving workers compensation, disability or who are involved in litigation will also be excluded due to risk of secondary gain.
Physical exam findings, X-rays, and US imaging will be utilized to determine eligibility.

What this trial measures

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

    The functionality of the lumbar spine will be measured by Oswestry Low Back Pain Disability Questionnaire, which is a tool to measure a patient's permanent functional disability. Each patient uses the questioner the first time they are in clinic and then in each of the follow up visits post treatment until the study completion. The questioner determines if the patient has sustained clinical improvement. The higher the score the more severe low back pain is.