Status:
COMPLETED
Safety and Efficacy of PRP for Treatment of Disc Pain
Lead Sponsor:
Neurological Associates of West Los Angeles
Collaborating Sponsors:
EmCyte Corporation
BioRich Medical
Conditions:
Discogenic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, thora...
Detailed Description
The study will recruit 180 subjects: 60 suffering from lumbar discogenic pain, 60 suffering from thoracic discogenic pain and 60 suffering from cervical discogenic pain. In each arm 40 study subjects ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 17 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2019
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04064866
Start Date
May 17 2016
End Date
February 18 2019
Last Update
December 4 2019
Active Locations (7)
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1
Comprehensive Spine and Sports Center
Campbell, California, United States, 89148
2
Neurological Associates of West LA
Santa Monica, California, United States, 90403
3
The Spine Institute: Center for Spinal Restoration
Santa Monica, California, United States, 90403
4
Thrive Treatment
Santa Monica, California, United States, 90405