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 range18 Years
SexALL
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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
✕. Unresolved neck or back pain from a previous cervical, thoracic or lumbar surgery at any level.
✕. Any contraindication for discography or surgery
✕. Significant signs or symptoms of root or cord compression at treatment levels.
✕. Any diagnosis of a concurrent pain disorder or other concurrent cause of disability.