Chronic Pain Clinical Trial
Official title:
Intradiscal Platelet-Rich Plasma Injection for Chronic Discogenic Low Back Pain
Verified date | December 2023 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 3 |
Est. completion date | July 29, 2022 |
Est. primary completion date | July 29, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah Orthopaedic Center | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numeric Rating Scale for Low Back Pain at 2-Month Follow-up | Proportion of participants with =80% and =50% reductions from baseline in 7-day average low back pain intensity scores on the Numeric Rating Scale (NRS) at the 2-month follow-up assessment. | 2 months | |
Secondary | Median Change in Low Back Pain Numeric Rating Scale (NRS) Score | The Numeric Rating Scale (NRS) was used to quantify low back pain by asking patients to rate their pain intensity on an 11-point scale ranging from 0 to 10, with 0 representing "no pain at all" and 10 representing "the worst pain imaginable". NRS change scores were calculated by subtracting baseline scores from follow-up scores, so that negative change scores correspond to decreases in low back pain. | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months | |
Secondary | Proportion of Patients With =30% Improvement From Baseline on the Oswestry Disability Index (ODI) | The Oswestry Disability Index (ODI) is an instrument used in clinical and research applications to quantify disability due to low back pain as a percentage score based on patients' self-reported level of function in activities of daily living. | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months | |
Secondary | Proportion of Patients With a =6 Score on Patient Global Impression of Change (PGIC) | Patient Global Impression of Change is a scale which measures participant reported satisfaction after an intervention. The outcome was measured as the percent of patients reporting a PGIC score of 6-7 (indicating "much improved" and "very much improved"). | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months | |
Secondary | Proportion of Patients With a Medication Quantification Scale (MQS) III Score Reduction From Baseline of =6.8 Points | A score of 6.8 points on the MQS III is equivalent to approximately 10 daily morphine equivalents | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months | |
Secondary | Oswestry Disability Index (ODI) Change Scores | The Oswestry Disability Index (ODI) is an instrument used in clinical and research applications to quantify disability due to low back pain as a percentage score (0-100%) based on patients' self-reported level of function in activities of daily living, with higher scores indicating greater disability. ODI change scores were calculated by subtracting baseline scores from follow-up scores, so that negative change scores correspond to functional improvements. | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months | |
Secondary | PROMIS PF CAT Change Scores | Patient-Reported Outcomes Measurement Information System Physical Function Computerized Adaptive Testing (PROMIS PF CAT) measures limitations of physical activity on a scale of 0 to 100, with higher scores indicating fewer limitations. PROMIS PF CAT change scores were calculated by subtracting baseline scores from follow-up scores, so that positive change scores represent improvements to functional limitations. | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months | |
Secondary | Pain and Sleep Questionnaire 3-Item Index (PSQ-3) Change Scores | The 3-Item Pain and Sleep Questionnaire is an instrument used in clinical and research applications to measure the impact of pain on sleep in chronic pain populations. A higher total score (range 0 to 300) indicates a greater extent of pain-related sleep interference. PSQ-3 change scores were calculated by subtracting baseline scores from follow-up scores, so that negative change scores correspond to reductions in pain-related sleep interference. | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months | |
Secondary | Patient Satisfaction Scores | The Patient Satisfaction Score represents patient satisfaction with the healthcare received using a five-point Likert scale where 1 = "very dissatisfied"; 2 = "dissatisfied"; 3 = "neither satisfied nor dissatisfied"; 4 = "satisfied"; and 5 = "very satisfied". | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months | |
Secondary | Patient Global Impression of Change (PGIC) Scores | Patient Global Impression of Change (PGIC) scores represent participants' overall satisfaction after an intervention. Participants are asked to rate their perception of change on a scale of 1 to 7, where 1="very much worse", 2="much worse", 3="worse", 4="no change", 5="improved", 6="much improved", and 7="very much improved". | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months | |
Secondary | Opioid Consumption in Daily Morphine Equivalents | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months | ||
Secondary | Proportion of Patients Who Underwent Lumbar Spinal Surgery During the Study Period | 24 months, 36 months |
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