The Ultrasound-Guided Dextrose Prolotherapy in Ehlers-Danlos Syndrome Patients

NCT ID: NCT05279937

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-12-31

Brief Summary

1. Specific Aim: To show the safety and efficacy of prolotherapy injection for chronic sacroiliac and myofascial lumbar pain while standardizing an ultrasound guided injection technique

2. Specific Aim: To demonstrate that dextrose prolotherapy subjectively decreases lumbar back pain (LBP) associated with chronic sacroiliac (SI) and myofascial lumbar back pain/injury in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS).

3. Specific Aim: To use ultrasound (US) guidance to identify SI and myofascial lumbar back pain/injury for targeted dextrose prolotherapy treatment and to provide objective measures of decreasing inflammation via Power Doppler and ligament repair.

4. Specific Aim: To determine if US-guided dextrose prolotherapy decreases the direct costs of care for chronic LBP in contrast to conventional therapies by reducing return visits, specialty referrals, physical therapy, medications, and unnecessary procedures.

Detailed Description

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 Hypermobile-Type Ehlers-Danlos Syndrome (hEDS). Ultrasound (US) will be used to assist in proper evaluation of the thoracolumbar fascial complex (TLFC), long posterior sacroiliac ligament (LPSL), multifidi and gluteus maximus along with precise administration of medication into identified regions of interest. By comparing targeted lidocaine and concentrated dextrose (prolotherapy) injections, placebo effect or therapeutic local trauma created by the needle, like dry needling can be ruled out. The combination of subjective data collection with Owestry Disability Index (ODI) and the Number Rating Scale (NRS) assessments and objective findings on ultrasound imaging such as Pixel Ratio and ligament integrity will provide sufficient information to determine if prolotherapy is effective at reducing inflammation, providing prolonged pain relief, and return to function in patients with hEDS.

Conditions

Ehlers-Danlos Syndrome; Low Back Pain; Sacroiliac Instability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Prolotherapy

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

Group Type: EXPERIMENTAL

Dextrose 50% Intravenous Solution

Intervention Type: DRUG

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

Control

10mL of 1% Lidocaine (Control)

Group Type: ACTIVE_COMPARATOR

Lidocaine 1% Injectable Solution

Intervention Type: DRUG

10mL of 1% Lidocaine (Control)

Interventions

Dextrose 50% Intravenous Solution

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

Intervention Type: DRUG

Lidocaine 1% Injectable Solution

10mL of 1% Lidocaine (Control)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men and women between the ages of 18-75
• 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 will include but not be limited to physical exam findings consistent with tenderness to palpation over the sacroiliac joint (SIJ) or posterior superior iliac crest, and upper outer quadrant of the gluteus maximus.
• Diagnosis will also include US-guided tenderness to palpation of the thoracolumbar facial complex insertion into the posterior superior iliac spine (PSIS), SI, or gluteus maximus.
• Further testing will include US evaluation using a General Electric Logiq E ultrasound machine to look for any evidence of structural abnormality or reactive hyperemia of the TLFC, LPSL, multifidus or gluteus maximus.

Exclusion Criteria

• Patients >75 and < 18 years old.
• Any patient with evidence of lumbar radiculopathy, acute lower back pain, pregnancy, prior lumbosacral surgery, opiate use within the last 6 months, steroid exposure within 6 weeks, NSAID exposure within 2 weeks.
• Patients who are unwilling to stop taking or admit to receiving NSAIDs or any form of corticosteroids during the study.
• Patients with a history of bleeding disorders, severe thrombocytopenia, immunodeficiency disorder, and hypersensitivity of local anesthetics of amide type will be excluded along with any patient who actively has systemic bacterial infection with fever, skin infection over the injection site, or takes anti-platelet/anti-coagulant medication.
• Patients with comorbidities such as diabetes mellitus, rheumatoid arthritis, lupus, or any other condition that increases risk of infection may be excluded from the study pending severity and current treatment of their condition.
• Patients receiving workers compensation, disability or who are involved in litigation will also be excluded due to risk of secondary gain.
• Physical exam findings, X-rays, and US imaging will be utilized to determine eligibility.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tulane University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Courseault, MD

Role: PRINCIPAL_INVESTIGATOR

Tulane University

Locations

Tulane Hospital and Clinics

New Orleans, Louisiana, United States

Countries

United States

Central Contacts

Orsula Staka, MBA

Role: CONTACT

ostaka@tulane.edu

628-800-4354

Facility Contacts

Orsula Staka, MBA

Role: primary

ostaka@tulane.edu

628-800-4354

Other Identifiers

2021-380

Identifier Type: -

Identifier Source: org_study_id