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Amniotic Fluid Injection for Spinal Stenosis
Study Summary
This trial is testing a new treatment, hAF, for lumbosacral radicular pain due to spinal stenosis, to see if it is more effective than the current treatment, dexamethasone injection.
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 am allergic to the medications used in injection procedures.I have had spinal fusion surgery.I experience pain when rotating my hip inward.My pain hasn't improved after 3 months of standard treatments.You have problems with thinking or memory, or you have a disease that affects your ability to control your muscles.I have severe lower back and leg pain, with the leg pain being worse than the back pain.It has been over 90 days since my last steroid injection.My scans show I have a narrowing in my lower back's spinal canal.I do not have severe heart or lung disease that limits my walking.I have a bleeding disorder or am currently on blood thinners.I do not have any infections, especially near where I might get an injection.I have a history of brain, nerve, or muscle diseases.I have leg pain that matches my scan results.I have a tumor inside my spinal cord.My cancer has spread to other parts of my body.I am 18 years old or older.I need surgery for my unstable spine.
- Group 1: Transforaminal epidural Amniotic Fluid injection
- Group 2: Transforaminal epidural dexamethasone injection
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
For what medical purposes is Amniotic Fluid Allograft often employed?
"Amniotic Fluid Allograft is a medical treatment used to ameliorate ophthalmia, sympathetic. It has also shown efficacy in treating other conditions such as branch retinal vein occlusion and macular edema."
How many subjects are included in this clinical investigation?
"That is correct. As of December 9th, 2021, the study detailed on clinicaltrials.gov is still looking for 112 participants across 1 location."
Does this clinical trial have open enrollment at the moment?
"Yes, this clinical trial is still open and actively recruiting participants. The listing was first posted on June 16th, 2021 and the 12/9/2021 update indicates that they are still looking for candidates."
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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