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Could amniotic fluid beat steroids for spinal stenosis pain?

NCT ID NCT04537026

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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