Dextrose Prolotherapy for Lower Back Pain in Ehlers-Danlos Syndrome

Recruiting in Palo Alto (17 mi)

Overseen byJacques Courseault, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Tulane University

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial aims to show that prolotherapy using a sugar solution can effectively reduce chronic back pain in patients with hEDS. The treatment works by reducing inflammation and repairing tissues, with the help of ultrasound for precise injections.

Eligibility Criteria

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.

Inclusion Criteria

I have pain in my lower back and upper buttock area.

Additional testing will use an ultrasound machine to look for any signs of structural issues or increased blood flow in certain muscles.

I have chronic low back pain diagnosed as SI dysfunction or myofascial pain and have been diagnosed with hEDS.

+6 more

Exclusion Criteria

We will use physical exams, X-rays, and ultrasound images to decide if you can join the study.

I do not have a fever from an infection, skin infection over the injection site, or take blood-thinning medication.

You have a history of severe bleeding problems, very low platelet count, weak immune system, or allergic reaction to certain local anesthetics.

+9 more

Participant Groups

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.

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)