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

40 Participants Needed

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.

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.

What data supports the effectiveness of the treatment Ultrasound-Guided Dextrose Prolotherapy for lower back pain in Ehlers-Danlos Syndrome?

Some studies suggest that dextrose prolotherapy may help with chronic musculoskeletal pain, including low back pain, by promoting healing in ligaments and tendons. However, the evidence is not conclusive, and more research is needed to confirm its effectiveness. ^{1 2 3 4 5}

Is dextrose prolotherapy safe for humans?

Dextrose prolotherapy is generally considered a safe treatment for chronic musculoskeletal pain, with studies indicating it is cost-effective and has a good safety profile. ^{3 4 5 6 7}

How is the treatment of dextrose prolotherapy unique for lower back pain in Ehlers-Danlos Syndrome?

Dextrose prolotherapy is unique because it involves injecting a sugar solution (dextrose) to stimulate the healing of ligaments and tendons, which may help reduce chronic pain. This approach is different from standard pain treatments as it aims to promote tissue repair rather than just alleviate symptoms. ^{3 4 5 8 9}

Research Team

Jacques Courseault, MD

Principal Investigator

Tulane University

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.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Dextrose Prolotherapy Versus Control Injections in Painful Rotator Cuff Tendinopathy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Prolotherapy for the Thoracolumbar Myofascial System. [2018]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Prolotherapy for the patients with chronic musculoskeletal pain: systematic review and meta-analysis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Retrospective case series on patients with chronic spinal pain treated with dextrose prolotherapy. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Critical review of prolotherapy for osteoarthritis, low back pain, and other musculoskeletal conditions: a physiatric perspective. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Side effects and adverse events related to intraligamentous injection of sclerosing solutions (prolotherapy) for back and neck pain: A survey of practitioners. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Dextrose Prolotherapy for Rotator Cuff Tendinopathy: A Systematic Review. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Dextrose prolotherapy for recalcitrant coccygodynia. [2022]