CompletedEarly Phase 1

Platelet-Rich Plasma (PRP) for Treatment of Symptomatic Lumbar Facet Syndrome of the Spine

United States5 participantsStarted 2021-02-19

Plain-language summary

The purpose of this study is to investigate the feasibility of standardized autologous platelet rich plasma injections into osteoarthritic lumbar facet joints to treat back pain and improve patient function.

Who can participate

Age range

18 Years – 95 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Suspicion of z-joint mediated low back pain * Pain rating of ≥4/10 on a VAS scale * Symptom duration of 3 or more months * Failed conservative therapy (minimum of PT and pain medications) * Have diagnosis of lumbar facet syndrome after MRI, X-ray, or CT imaging of any severity and a medial branch block with local anesthetic that confirms lumbar facet pathology. Exclusion Criteria: * Inability to undergo fluoroscopically guided procedures * Current pregnancy * Prior spinal surgery with hardware * Intolerance to local anesthesia, contrast medium, or blood derivatives * Local or systemic infection or spinal infection * Irreversible coagulopathy * Patients that require strict anticoagulation and cannot be off antiplatelet medication for at least a week * Less than 18 years of age * Corticosteroid shot within last 3 months into affected lumbar facet joint because of concern of damage to cartilage in the joint in that time period. * Patients with workman compensation related back pain * Patients with rheumatic cause of lumbar facet arthritis. * Patients who have had a radiofrequency neurotomy of the nerves innervating their affected facet joints within the last year

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in pain Visual Analog Score with back flexion and at rest from baseline after intervention over time.

Timeframe: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention

PROMIS Survey for Low Back Pain Function (PROMIS-29)

Timeframe: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention

Trial details

NCT IDNCT04522674

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-28

View on ClinicalTrials.gov More Platelet-Rich Plasma trials

Who can participate

Age range

18 Years – 95 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in pain Visual Analog Score with back flexion and at rest from baseline after intervention over time.

Timeframe: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention

PROMIS Survey for Low Back Pain Function (PROMIS-29)

Timeframe: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention