Safety and Efficacy of PRP for Treatment of Disc Pain

Completed · Not applicable · Has a placebo group

Conditions studied: Discogenic Pain

In brief

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.

Key facts

Study ID

NCT04064866

Run by

Neurological Associates of West Los Angeles

People needed

27

Starts

2016-05-17

Expected to finish

2019-02-18

Last updated by the study team

2019-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.
• Daily opioid requirements of greater than180 mg oral morphine equivalent
• (OME) per day.
• Current active systemic infection, or history of disc infection.
• Untreated disabling thought or mood disorder.
• Inability to provide informed consent including subjects in a socially compromised condition such as prisoners.

Where it is running

• Comprehensive Spine and Sports Center — Campbell, California, United States
• Neurological Associates of West LA — Santa Monica, California, United States
• The Spine Institute: Center for Spinal Restoration — Santa Monica, California, United States
• Thrive Treatment — Santa Monica, California, United States
• Georgia Pain and Spine — Peachtree City, Georgia, United States
• Millenium Pain Center — Chicago, Illinois, United States
• Precision Spine Care — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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