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

NCT05279937 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 2021-380
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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. 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.

Conditions

Low Back Pain; Sacroiliac Instability; Ehlers-Danlos Syndrome

Keywords

Prolotherapy; Dextrose; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Measuring the functionality of the lumbar spine by using Oswestry Low Back Pain Disability Questionnaire in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS)

  The functionality of the lumbar spine will be measured by Oswestry Low Back Pain Disability Questionnaire, which is a tool to measure a patient's permanent functional disability. Each patient uses the questioner the first time they are in clinic and then in each of the follow up visits post treatment until the study completion. The questioner determines if the patient has sustained clinical improvement. The higher the score the more severe low back pain is.

  12 Months

Secondary Outcomes (3)

• Measuring the change of low back pain via the number rating scale in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS)

  12 Months

• The measure of soft tissue inflammation via ultrasound in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS)

  12 Months

• The measure of ligament integrity via ultrasound in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS)

  12 Months

Study Arms (2)

Prolotherapy

EXPERIMENTAL

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

Drug: Dextrose 50% Intravenous Solution

Control

ACTIVE COMPARATOR

10mL of 1% Lidocaine (Control)

Drug: Lidocaine 1% Injectable Solution

Interventions

Dextrose 50% Intravenous Solution DRUG

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

Prolotherapy

Lidocaine 1% Injectable Solution DRUG

10mL of 1% Lidocaine (Control)

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tulane University: lead

Study Sites (1)

Tulane Hospital and Clinics

New Orleans, Louisiana, 70118, United States

Location

MeSH Terms

Conditions

Ehlers-Danlos Syndrome; Low Back Pain

Interventions

Glucose; Lidocaine

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jacques Courseault, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Orsula Staka, MBA

CONTACT

628-800-4354; ostaka@tulane.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded randomized
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 10mL of 1% Lidocaine (Control) or 5mL of 50% Dextrose + 5mL of 1% Lidocaine (Prolotherapy).

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 15, 2022
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (1)