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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05279937
Recruitment Status : Not yet recruiting
First Posted : March 15, 2022
Last Update Posted : July 21, 2023
Sponsor:
Information provided by (Responsible Party):
Tulane University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ehlers-Danlos Syndrome Low Back Pain Sacroiliac Instability Drug: Dextrose 50% Intravenous Solution Drug: Lidocaine 1% Injectable Solution Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 10mL of 1% Lidocaine (Control) or 5mL of 50% Dextrose + 5mL of 1% Lidocaine (Prolotherapy).
Masking: Double (Participant, Investigator)
Masking Description: Double blinded randomized
Primary Purpose: Treatment
Official Title: The Use of Ultrasound-Guided Dextrose Prolotherapy in Low Back Pain in Patients With Hypermobile-Type, Ehlers-Danlos Syndrome
Estimated Study Start Date : August 1, 2023
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Prolotherapy
5mL of 50% Dextrose + 5mL of 1% Lidocaine (Prolotherapy).
 Drug: Dextrose 50% Intravenous Solution
5mL of 50% Dextrose + 5mL of 1% Lidocaine (Prolotherapy).
Active Comparator: Control
10mL of 1% Lidocaine (Control)
 Drug: Lidocaine 1% Injectable Solution
10mL of 1% Lidocaine (Control)


Outcome Measures
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Primary Outcome Measures :
  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) [ Time Frame: 12 Months ]
    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 :
  1. Measuring the change of low back pain via the number rating scale in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS) [ Time Frame: 12 Months ]
    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.

  2. The measure of soft tissue inflammation via ultrasound in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS) [ Time Frame: 12 Months ]
    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.

  3. The measure of ligament integrity via ultrasound in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS) [ Time Frame: 12 Months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05279937


Contacts
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Contact: Taylor Johnson 504-988-0100 tjohnson2@tulane.edu
Contact: Admin Email 504-988-0100 admin@fasciainstitute.org

Locations
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United States, Louisiana
Tulane Hospital and Clinics
New Orleans, Louisiana, United States, 70118
Contact: Thomas Hodo, MD, MS    404-408-7234    thodo@tulane.edu   
Contact: Wendell Cole, MD    3106923669    wcole@tulane.edu   
Principal Investigator: Jacques Courseault, MD         
Sponsors and Collaborators
Tulane University
Investigators
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Principal Investigator: Jacques Courseault, MD Tulane University
More Information
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Responsible Party: Tulane University
ClinicalTrials.gov Identifier: NCT05279937    
Other Study ID Numbers: 2021-380
First Posted: March 15, 2022    Key Record Dates
Last Update Posted: July 21, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tulane University:
Prolotherapy
Dextrose
Ultrasound
Additional relevant MeSH terms:
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Ehlers-Danlos Syndrome
Syndrome
Back Pain
Low Back Pain
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
 Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases
Lidocaine
Pharmaceutical Solutions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers