Back to results

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

Primary Purpose

Ehlers-Danlos Syndrome, Low Back Pain, Sacroiliac Instability

Status

Not yet recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Dextrose 50% Intravenous Solution

Lidocaine 1% Injectable Solution

About this trial

This is an interventional treatment trial for Ehlers-Danlos Syndrome focused on measuring Prolotherapy, Dextrose, Ultrasound

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Tulane Hospital and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prolotherapy

Control

Arm Description

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

10mL of 1% Lidocaine (Control)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

The change in low back pain will be measured by the number rating scale, which is a scale from 1 to 10 measuring low back pain. The higher the score the more severe the pain is in the low back.

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

Inflammation will be measured by Doppler ultrasound to determine the degree of inflammation in the area of interest which is measured as Pixel Ration (PR) to show if there is a change or decrease of inflammation with prolotherapy treatment.

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

Ligament Integrity will be measured by ultrasound, which will be used to evaluate the quality of ligamentous structures before and after prolotherapy treatment to determine if prolotherapy has the ability to promote tissue regeneration.

Full Information

NCT ID

NCT05279937

First Posted

March 4, 2022

Last Updated

July 20, 2023

Sponsor

Tulane University

1. Study Identification

Unique Protocol Identification Number

NCT05279937

Brief Title

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

Official Title

The Use of Ultrasound-Guided Dextrose Prolotherapy in Low Back Pain in Patients With Hypermobile-Type, Ehlers-Danlos Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 1, 2023 (Anticipated)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tulane University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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 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). 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ehlers-Danlos Syndrome, Low Back Pain, Sacroiliac Instability

Keywords

Prolotherapy, Dextrose, Ultrasound

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigator

Masking Description

Double blinded randomized

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prolotherapy

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Active Comparator

Arm Description

10mL of 1% Lidocaine (Control)

Intervention Type

Drug

Intervention Name(s)

Dextrose 50% Intravenous Solution

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Lidocaine 1% Injectable Solution

Intervention Description

10mL of 1% Lidocaine (Control)

Primary Outcome Measure Information:

Title

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

Description

Time Frame

12 Months

Secondary Outcome Measure Information:

Title

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

Description

The change in low back pain will be measured by the number rating scale, which is a scale from 1 to 10 measuring low back pain. The higher the score the more severe the pain is in the low back.

Time Frame

12 Months

Title

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

Description

Time Frame

12 Months

Title

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

Description

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Taylor Johnson

Phone

504-988-0100

tjohnson2@tulane.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Admin Email

Phone

504-988-0100

admin@fasciainstitute.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacques Courseault, MD

Organizational Affiliation

Tulane University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tulane Hospital and Clinics

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70118

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Hodo, MD, MS

Phone

404-408-7234

thodo@tulane.edu

First Name & Middle Initial & Last Name & Degree

Wendell Cole, MD

Phone

3106923669

wcole@tulane.edu

First Name & Middle Initial & Last Name & Degree

Jacques Courseault, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs