Dextrose Prolotherapy for Lower Back Pain in Ehlers-Danlos Syndrome

Overseen By Orsula Staka, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Tulane University

Must not be taking: Opiates, Steroids, NSAIDs, Anticoagulants

Disqualifiers: Lumbar radiculopathy, Diabetes, Lupus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called dextrose prolotherapy to determine its safety and effectiveness in reducing chronic lower back pain in individuals with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS). The treatment involves an ultrasound-guided injection targeting specific pain areas in the lower back. Participants will receive either the prolotherapy treatment or a control injection with lidocaine, a common numbing medication. Individuals with chronic lower back pain for over three months due to sacroiliac or myofascial issues and diagnosed with hEDS are suitable candidates for the trial. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants an opportunity to contribute to the validation of a promising treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking NSAIDs (non-steroidal anti-inflammatory drugs) and corticosteroids during the study. If you are currently using these medications, you will need to discontinue them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dextrose prolotherapy, which uses a sugar solution, is generally well-tolerated. Studies on this treatment for chronic muscle and joint pain have found it effective and safe. Clinics, especially those treating individuals with Ehlers-Danlos Syndrome (EDS), use dextrose prolotherapy without major safety concerns. Reports highlight its particular benefit for patients with joint hypermobility, such as those with EDS, and note few side effects. This suggests the treatment is safe for use in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lower back pain in Ehlers-Danlos Syndrome?

Unlike the standard care options for lower back pain in Ehlers-Danlos Syndrome, such as physical therapy, pain medications, or surgery, dextrose prolotherapy uses a unique approach. This treatment involves injecting a solution of concentrated dextrose and lidocaine directly into the affected area under ultrasound guidance. The excitement around this method stems from its potential to stimulate the body's natural healing process, promoting tissue repair and reducing pain over time. Researchers are particularly interested in its ability to offer a less invasive and potentially more sustainable option for managing chronic pain.

What evidence suggests that ultrasound-guided dextrose prolotherapy is effective for lower back pain in Ehlers-Danlos Syndrome?

Studies have shown that dextrose prolotherapy can greatly reduce pain in people with long-term back pain, especially those with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS). Specifically, patients who received this treatment reported significant pain relief three months later. In this trial, participants in the experimental arm will receive prolotherapy, which involves injecting a sugar solution to help the body heal itself, potentially repairing damaged tissues and reducing swelling. This treatment has proven particularly effective for individuals with joint flexibility issues like hEDS. Ultrasound assists doctors in accurately targeting the painful areas with the injections. ^{1 3 4 5 6}

Who Is on the Research Team?

Jacques Courseault, MD

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ultrasound-guided dextrose prolotherapy injections for chronic low back pain

12 months

Regular visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up visits for assessments using ultrasound and questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound-Guided Dextrose Prolotherapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Prolotherapy Experimental Treatment 1 Intervention

5mL of 50% Dextrose + 5mL of 1% Lidocaine (Prolotherapy).

Group II: Control Active Control 1 Intervention

10mL of 1% Lidocaine (Control)

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05279937

The Ultrasound-Guided Dextrose Prolotherapy in Ehlers ... The goal of this research project is to prove that ultrasound-guided prolotherapy is a cost effective and curative treatment option for chronic low back pain in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12472176/

Prolotherapy as a Regenerative Treatment in the ... At the three-month follow-up, patients from the prolotherapy group had a significant improvement regarding the pain, with significantly lower ...

3. withpower.com withpower.com/trial/phase-3-ehlers-danlos-syndrome-4-2022-c010c

Dextrose Prolotherapy for Lower Back Pain in Ehlers ... This trial aims to show that prolotherapy using a sugar solution can effectively reduce chronic back pain in patients with hEDS.

4. fasciainstitute.org fasciainstitute.org/dextrose-prolotherapy-review-lower-extremity-injuries/

Dextrose Prolotherapy Review for Lower Extremity Injuries In our clinic, dextrose prolotherapy is particularly effective in patients who are hypermobile or have Ehlers-Danlos syndrome. This review ...

5. trials.arthritis.org trials.arthritis.org/trials/NCT05279937

The Ultrasound-Guided Dextrose Prolotherapy in Ehlers ... Ultrasound-guided prolotherapy is a cost effective and curative treatment option for chronic low back pain in Hypermobile-Type Ehlers-Danlos Syndrome (hEDS).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4938120/

A Systematic Review of Dextrose Prolotherapy for Chronic ... The aim of this study was to systematically review dextrose (d-glucose) prolotherapy efficacy in the treatment of chronic musculoskeletal pain.