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Sciatica treatment trial fizzles out after just 2 patients

NCT ID NCT06924853

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This small study tested whether an injection made from a patient's own blood (platelet lysate) could reduce leg pain from sciatica better than a saltwater injection. Only 2 people took part before the study was stopped early, so we cannot draw any firm conclusions. The approach remains experimental.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
platelet lysate
What this could lead to
If it worked, this could point toward a treatment for sciatica using a patient's own blood components.
What could go wrong
The trial was terminated early with only 2 participants, so we have almost no reliable data. It is unclear if platelet lysate helps more than a placebo.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

2 people

The number who actually took part.

Started

Jul 2025

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

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. Must be 18-65 years of age, inclusive, at time of signing informed consent 2. At least moderate pain at screening using Patient Global Impression of Severity (PGIS) 3. Diagnosis of lumbosacral radiculopathy (LSR) radiating to or below the knee in a single dermatomal pattern (L4, L5, or S1) with onset of clinical symptoms less than 2 year prior to screening visit 4. Presence of one of the following: a radicular pattern (L4, L5, or S1) of sensory, reflex or strength changes 5. Presence of persistent unilateral radicular pain. Have significant leg pain, numbness, or tingling that causes the patient to alter or change activities. 6. LSR pain with inadequate response to conservative care (non-operative); participants must have tried at least one anti-inflammatory or analgesic medication (for at least 2 weeks at adequate doses) and at least one of the following: Physical therapy, bed rest, chiropractic manipulations, home directed lumbar and/or exercise programs. 7. Lumbar spine MRI images are available after the onset of clinical symptoms and correlate with localization of clinical symptoms. CT is acceptable for patients with contraindication for MRI. 8. Is independent, ambulatory, and can comply with post-treatment evaluations and visits. 9. Voluntary signature of the IRB approved Informed Consent Exclusion Criteria: 1. Untreated underlying psychological conditions (e.g. depression, chronic pain syndrome, etc.) as a contributor of pain 2. Bleeding disorders 3. Currently taking anticoagulant or immunosuppressive medication 4. Evidence on MRI or CT of recent vertebral fracture or segmental instability (spondylolisthesis) 5. Inflammatory or auto-immune based pathology (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudogout, etc.) 6. Co-existing hip or knee pain localized to the joint structures that may interfere with the participant's ability to participate in the study or interfere with pain assessments 7. Any central canal stenosis with neurogenic claudication (not including foraminal stenosis) with pain present mostly during walking and signs of lumbar stenosis on lumbar spine MRI/CT 8. Has undergone a surgical procedure for back pain (e.g. discectomy, artificial disc replacement, fusion, etc) 9. Presence of spinal cord stimulator 10. Received epidural steroid injection or nerve blocks within the last 2 months 11. Use of chronic opioids 12. Documented history of drug abuse within the last 6 months 13. Use of immunosuppressants, oral or intravenous steroids in the last 3 months 14. Is pregnant 15. Allergy or intolerance to study medication (e.g. lidocaine, etc.) 16. Condition represents a worker's comp case and/or is involved in health-related litigation 17. Presence of clinically significant disease that may interfere with the evaluation of safety and other clinical outcomes in the study 18. Any other condition, that in the opinion of the investigator, would preclude the patient from enrollment.

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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

  • Centeno-Schultz Clinic

    Broomfield, Colorado, 80021, United States

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