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Could amniotic fluid beat steroids for spinal stenosis pain?
NCT ID NCT04537026
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested whether an injection of amniotic fluid, a natural anti-inflammatory, works better than a standard steroid injection for chronic back and leg pain caused by spinal stenosis. Sixty-one adults who had not improved with other treatments were randomly assigned to receive either the amniotic fluid or a steroid. The goal was to see if the amniotic fluid could reduce pain and disability with fewer side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- amniotic fluid allograft
- What this could lead to
- If it works, this could offer a safer, longer-lasting option for chronic back and leg pain from spinal stenosis, helping people avoid surgery.
- What could go wrong
- This is an early-phase trial with only 61 people, so results may not apply widely. The amniotic fluid treatment might not be more effective than the standard steroid injection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
61 people
The number who actually took part.
- Started
-
Jun 2021
- Finished
-
Jul 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients who are ≥ 18 years old 2. Pain in the low back and lower extremity (pain NRS \>4) with buttock/leg pain \> back pain. 3. Radicular distribution of leg pain based on history and correlation with advancing imaging. Radicular pain may be fixed or claudicatory in nature. 4. Pain resistant to a trial of conservative therapy (i.e. oral steroids, NSAIDs, opioids, muscle relaxants, physical therapy, chiropractic or other non-invasive care) for at least 3 months. 5. Mild-moderate-severe lumbar foraminal or subarticular zone stenosis, and/or mild-moderate central canal spinal stenosis identified by MRI or CT scan according to radiologic criteria (Boden 1996). 6. Ability to read English and complete the assessment questionnaires. 7. Must have been 90 days since last steroid injection. Exclusion Criteria: 1. Patients in the opinion of the treating investigator who are unwilling or unable to comply with study procedures. 2. Systemic infection or local infection over planned injection site. 3. Bleeding disorder, current use of anticoagulants or anti-platelet medications. 4. Intrinsic spinal cord lesions. 5. History of central neurologic, cerebrovascular, demyelinating or muscular disease. 6. Severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction (within the last 6 months). 7. Allergy to medications being used for injection procedures. 8. Women who are pregnant, breastfeeding, or plan to become pregnant while participating in the study. If of child-bearing potential, unwillingness to use effective birth control while participating in the study. 9. Cognitive deficit or motor neuron disease. 10. Spinal instability requiring surgery. 11. History of spinal fusion surgery 12. Metastatic cancer. 13. Concordant pain with internal rotation of the hip (or known hip joint pathology)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108, United States
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