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

Launched by TULANE UNIVERSITY · Mar 4, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called dextrose prolotherapy for patients with Ehlers-Danlos Syndrome (hEDS) who experience chronic low back pain, specifically from sacroiliac joint issues or muscle pain in the lower back. The goal of the study is to see if this injection therapy, guided by ultrasound, can safely reduce pain and inflammation, while also cutting down on the need for other medical treatments, like physical therapy or medications.

To be eligible for the trial, participants must be between 18 and 75 years old and have been diagnosed with chronic low back pain related to their hEDS. They will undergo assessments, including physical exams and ultrasound imaging, to confirm their condition. The study has not yet started recruiting participants, but those who join can expect to receive targeted treatment aimed at easing their pain and improving their quality of life. Keep in mind that certain health conditions and medications may disqualify some individuals from participating in the trial.

Gender

ALL

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.