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Dextrose Prolotherapy for Lower Back Pain in Ehlers-Danlos Syndrome

Phase 3
Waitlist Available
Led By Jacques Courseault, MD
Research Sponsored by Tulane University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 to include US-guided tenderness to palpation of the thoracolumbar facial complex insertion into the posterior superior iliac spine (PSIS), SI, or gluteus maximus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing the safety and efficacy of prolotherapy injections to treat chronic sacroiliac and myofascial lumbar pain. The injections will be guided by ultrasound, and the goal is to reduce pain and inflammation while also reducing the overall cost of care for patients with this condition.

Who is the study for?
This trial is for adults aged 18-75 with chronic sacroiliac or myofascial lumbar pain diagnosed as Hypermobile-Type Ehlers-Danlos Syndrome (hEDS). Participants must have specific tenderness in the lower back and be willing to stop NSAIDs and steroids. Excluded are those with bleeding disorders, severe allergies to local anesthetics, infections, certain comorbidities like diabetes or lupus, recent opiate or steroid use, previous lumbosacral surgery, or involved in litigation.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of ultrasound-guided dextrose prolotherapy injections for reducing lower back pain from sacroiliac instability in hEDS patients. It aims to standardize injection techniques while assessing cost-effectiveness compared to conventional therapies.See study design
What are the potential side effects?
Possible side effects include discomfort at the injection site, allergic reactions to lidocaine used during treatment, increased inflammation temporarily following the procedure, and potential bruising or bleeding especially if there's a pre-existing clotting disorder.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have chronic low back pain diagnosed as SI dysfunction or myofascial pain and have been diagnosed with hEDS.
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I have pain in my lower back or buttock diagnosed with an ultrasound.
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I have pain when pressure is applied to my lower back or buttock area.
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I have been diagnosed with hEDS and have chronic SI or lumbar pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome 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)
Secondary outcome measures
Measuring the change of low back pain via the number rating scale in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS)
The measure of ligament integrity via ultrasound in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS)
The measure of soft tissue inflammation via ultrasound in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ProlotherapyExperimental Treatment1 Intervention
5mL of 50% Dextrose + 5mL of 1% Lidocaine (Prolotherapy).
Group II: ControlActive Control1 Intervention
10mL of 1% Lidocaine (Control)

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Dextrose prolotherapy is a common treatment for Ehlers-Danlos Syndrome (EDS) that involves injecting a dextrose solution into ligaments and tissues to promote inflammation and subsequent healing. This treatment works by stimulating the body's natural healing processes, leading to the repair and strengthening of weakened connective tissues, which are a hallmark of EDS. This is particularly important for EDS patients, as their connective tissues are often fragile and prone to injury, causing chronic pain and joint instability. By enhancing tissue repair and reducing pain, dextrose prolotherapy can improve the quality of life for individuals with EDS.
Application of ultrasound in a case of eosinophilic fasciitis mimicking stiff-person syndrome.Extracorporeal Shock Wave Therapy for Achilles Tendinopathy.Dextrose prolotherapy versus radial extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis: A randomized, controlled clinical trial.

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Who is running the clinical trial?

Tulane UniversityLead Sponsor
117 Previous Clinical Trials
237,585 Total Patients Enrolled
Jacques Courseault, MDPrincipal InvestigatorTulane University

Media Library

Ultrasound-Guided Dextrose Prolotherapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05279937 — Phase 3
~27 spots leftby Sep 2025
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