Safety and Efficacy of PRP for Treatment of Disc Pain (NCT04064866) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of PRP for Treatment of Disc Pain
United States27 participantsStarted 2016-05-17
Plain-language summary
This is a multi-center, randomized, controlled, double-blind clinical trial comparing hemocyte autograft (platelet rich plasma) to control injection (placebo) in subjects with reported cervical, thoracic or lumbar pain for at least 3 months with Pfirrmann grade changes at 7 or less and who are being considered for discography in order to identify pain generator discs in evaluation of potential surgical candidates.
Who can participate
Age range
18 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
. Male or Female at least 18 years of age.
. Clinically suspected discogenic pain in the cervical, thoracic or lumbar spine.
. Bring considered for discography in order to identify source of pain in the evaluation of potential surgical candidates.
. History of neck pain or mid or low back pain for at least 3 months.
. Failed to respond to conservative therapies that include physical therapy and analgesics.
. Documented Pfirrmann grade changes of 7 or less at each treatment level as represented by an MRI no more than 12 months old (extravasation not excluded).
Exclusion criteria
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
1
Patient Specific Functional Scale (PSFS)
Timeframe: 8 weeks from baseline
2
Adverse Event Reporting
Timeframe: Baseline to 26 weeks
Trial details
NCT IDNCT04064866
SponsorNeurological Associates of West Los Angeles