Intradiscal Platelet Rich Plasma

• Status: Recruiting
• Trial end date: 2024-07-30
• Target enrollment: 0
• Participant gender: All

Summary

To assess changes in pain and function in patients with discogenic low back pain after a standard of care intradiscal injection of Platelet-Rich Plasma (PRP).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah

Criteria

Inclusion Criteria:

1. Age greater than 18 years of age at day of enrollment.

2. Clinical diagnosis of refractory discogenic low back pain for >3 months.

3. Magnetic resonance imaging pathology consistent with clinical symptoms/signs or positive lumbar provocative discography according to SIS/IASP standards at one or two levels.

4. Back pain greater than leg pain with an intensity of at least 4/10 or higher using the Numerical Rating Scale (NRS).

5. Pain duration of more than 12 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care) for 2 months.

Exclusion Criteria:

1. Refusal to participate, provide consent, or provide follow-up information for the 24-month duration of the study.

2. Contraindications to intradiscal injection of PRP (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to iodinated contrast, penicillin or clindamycin and pregnancy or breastfeeding).

3. More than 2 levels of clinical or discogram proven pain.

4. Non-discogenic source of low back pain as identified by separate diagnostic blocks.

5. Negative lumbar provocation discography.

6. Active moderate to severe lumbar radiculopathy.

7. Intradural disc herniation.

8. Spinal fracture within the past 6 months.

9. Steroid injection in the spine within the last 30 days.

10. Any intradiscal injection other than contrast dye or anesthetic in the last 30 days.

11. Prior fusion at level considered to be the source of the pain.

12. Prior lumbar spine surgery within the last 6 months.

13. AP diameter of spinal canal less than or equal to 9mm at level to be treated.

14. Severe uncontrolled medical condition.

15. Moderate to severe hepatic dysfunction.

16. Severe psychological illness.

17. History of Inflammatory arthritis.

18. Malignancy within past 5 years except basal cell or squamous cell skin cancer.

19. Current use of equal to greater than 30mg morphine-equivalent per day of opioid use.

20. A history of alcohol or drug abuse within past 5 years.

21. Use of any investigational drug within past 30 days.

22. A known allergy or sensitivity to citrate (used for processing PRP).

23. Severe anaphylactic/anaphylactoid reaction to any medications used.

24. Pending litigation involving subject's back pain.

25. No insurance coverage for any subsequent tests or procedures.

26. Disc protrusion greater than 5mm from base of vertebral body.

27. Greater than 50% disc height loss at involved level(s).

28. Inability or unwillingness to continue rehabilitation protocols.