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Dextrose Prolotherapy for Lower Back Pain in Ehlers-Danlos Syndrome
Study Summary
This trial is testing the safety and efficacy of prolotherapy injections to treat chronic sacroiliac and myofascial lumbar pain. The injections will be guided by ultrasound, and the goal is to reduce pain and inflammation while also reducing the overall cost of care for patients with this condition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have chronic lower back pain diagnosed as SI dysfunction or myofascial pain and meet the criteria for hEDS.I have pain in my lower back and upper buttock area.We will use physical exams, X-rays, and ultrasound images to decide if you can join the study.Additional testing will use an ultrasound machine to look for any signs of structural issues or increased blood flow in certain muscles.I am between 18 and 75 years old.I am between 18 and 75 years old.I have pain in my lower back and upper buttock area.I have chronic low back pain diagnosed as SI dysfunction or myofascial pain and have been diagnosed with hEDS.My diagnosis includes pain in my lower back or buttock area confirmed by a US-guided exam.Additional testing will involve using a specific ultrasound machine to look for any abnormalities or increased blood flow in certain muscles.My diagnosis includes pain in my lower back or buttock area confirmed by a special ultrasound.I have pain in my lower back or buttock diagnosed with an ultrasound.I have pain when pressure is applied to my lower back or buttock area.I do not have a fever from an infection, skin infection over the injection site, or take blood-thinning medication.The diagnosis will also involve checking for tenderness in certain areas of the back and hips using ultrasound guidance.You have a history of severe bleeding problems, very low platelet count, weak immune system, or allergic reaction to certain local anesthetics.I am willing to stop taking NSAIDs and corticosteroids during the study.I have taken NSAIDs in the last 2 weeks.I am between 18 and 75 years old.I have lower back pain or sciatica.I have a condition like diabetes or lupus that might increase my risk of infection.I have had surgery on my lower back or pelvis before.You are currently receiving workers compensation, disability, or are involved in a lawsuit.I have been diagnosed with hEDS and have chronic SI or lumbar pain.I have used opiates in the last 6 months or steroids in the last 6 weeks.I am between 18 and 75 years old.I have chronic low back pain diagnosed as SI dysfunction or myofascial pain and have been diagnosed with hEDS.You will have an ultrasound to check for any problems in certain muscles of your lower back and buttocks.I have pain in my lower back and upper buttock area.
Frequently Asked Questions
Might I be able to join this experiment?
"This study is seeking 40 individuals aged 18-75 that have ehlers-danlos syndrome. Eligible patients will exhibit US-guided tenderness to palpation of the thoracolumbar facial complex insertion into the posterior superior iliac spine (PSIS), SI, or gluteus maximus. both men and women are encouraged to apply. 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"
Is Dextrose 50% Intravenous Solution cleared by the FDA?
"Dextrose 50% Intravenous Solution is considered safe based on prior clinical trials and data, and thus received a score of 3."
Are octogenarians welcome in this research project?
"The investigators leading this study are looking for participants who are under 75 years old and have already celebrated their 18th birthday."
Are there any current openings for new participants in this research?
"This particular study, as evidenced by clinicaltrials.gov, is not currently looking for participants. The listing for this trial was created on October 1st, 2022 and was last updated on August 25th, 2022. Even though this study is not accepting patients, there are 1,779 other trials that are."
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