Health TrialsbyHealthPanel

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

ConditionsEhlers-Danlos SyndromeLow Back PainSacroiliac Instability
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTulane University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dextrose 50% Intravenous Solution

    Drug

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

  • Lidocaine 1% Injectable Solution

    Drug

    10mL of 1% Lidocaine (Control)

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: ProlotherapyExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

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.

Time frame
12 Months

Secondary outcomes

1

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.

Time frame
12 Months
2

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.

Time frame
12 Months
3

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.

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tulane University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: