What side effects are associated with this type of intervention?

Dextrose prolotherapy, used to treat chronic pain and promote healing in Ehlers-Danlos Syndrome, is generally well-tolerated with minimal side effects. Common side effects may include temporary pain or swelling at the injection site. Other treatments for EDS, such as physical therapy and pain management medications, can have side effects like muscle soreness, gastrointestinal issues, and potential dependency on pain medications. Overall, dextrose prolotherapy appears to be a safe option with fewer side effects compared to more invasive treatments.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs for the treatment of Ehlers-Danlos Syndrome (EDS). Management of EDS typically focuses on symptomatic relief and supportive care, including physical therapy, pain management, and sometimes surgical interventions. Dextrose prolotherapy, which is being studied for its potential to promote inflammation and healing of ligaments and tissues, is not yet FDA-approved for EDS but is being explored as a treatment option for chronic pain and joint instability associated with the condition.

What other types of research exist?

One promising alternative to dextrose prolotherapy for Ehlers-Danlos Syndrome patients is polydeoxyribonucleotide (PDRN) injections. PDRN has shown greater improvement in tendon healing and functional scores in patients with lateral epicondylitis, which suggests its potential for promoting ligament and tissue healing in EDS patients.

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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

Must not have

Patients with systemic bacterial infection with fever, skin infection over the injection site, or taking anti-platelet/anti-coagulant medication

Patients unwilling to stop taking or admit to receiving NSAIDs or any form of corticosteroids during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am willing to stop taking NSAIDs and corticosteroids during the study.

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I am between 18 and 75 years old.

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I have lower back pain or sciatica.

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I have had surgery on my lower back or pelvis before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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)

0 / 9Eligibility criteria met

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.