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

• ClinicalTrials.gov Identifier: NCT05279937
• Recruitment Status: Not yet recruiting
• First Posted: March 15, 2022
• Last Update Posted: December 21, 2023
• Sponsor: Tulane University
• Information provided by (Responsible Party): Tulane University

Tracking Information

• First Submitted Date: March 4, 2022
• First Posted Date: March 15, 2022
• Last Update Posted Date: December 21, 2023
• Estimated Study Start Date: September 2024
• Estimated Primary Completion Date: September 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 4, 2022)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 4, 2022)

• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

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

Condition

• Ehlers-Danlos Syndrome
• Low Back Pain
• Sacroiliac Instability

Intervention

• Drug: Dextrose 50% Intravenous Solution
  5mL of 50% Dextrose + 5mL of 1% Lidocaine (Prolotherapy).
• Drug: Lidocaine 1% Injectable Solution
  10mL of 1% Lidocaine (Control)

Study Arms

• Experimental: Prolotherapy
  5mL of 50% Dextrose + 5mL of 1% Lidocaine (Prolotherapy).
  Intervention: Drug: Dextrose 50% Intravenous Solution
• Active Comparator: Control
  10mL of 1% Lidocaine (Control)
  Intervention: Drug: Lidocaine 1% Injectable Solution

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: March 4, 2022): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2025
• Estimated Primary Completion Date: September 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Patrick Bordnick, MS; 713-299-3132; bordnick@tulane.edu

Contact: Taylor Johnson; 504-988-0100; tjohnson2@tulane.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05279937
• Other Study ID Numbers: 2021-380
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Tulane University
• Original Responsible Party: Same as current
• Current Study Sponsor: Tulane University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jacques Courseault, MD; Tulane University

• PRS Account: Tulane University
• Verification Date: December 2023