Platelet-Rich Plasma (PRP) for Treatment of Symptomatic Lumbar Facet Syndrome of the Spine

Platelet-Rich Plasma Clinical Trial

Official title:

A Pilot Trial Evaluating the Feasibility of Using Platelet-Rich Plasma (PRP) for Treatment of Symptomatic Osteoarthritis of the Lumbar Facet Joint(s) of the Spine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04522674
• Other study ID #: 19-3066
• Status: Completed
• Phase: Early Phase 1
• Start date: February 19, 2021
• Est. completion date: April 28, 2022

Study information

• Verified date: May 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the feasibility of standardized autologous platelet rich plasma injections into osteoarthritic lumbar facet joints to treat back pain and improve patient function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 28, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Suspicion of z-joint mediated low back pain

• Pain rating of =4/10 on a VAS scale

• Symptom duration of 3 or more months

• Failed conservative therapy (minimum of PT and pain medications)

• Have diagnosis of lumbar facet syndrome after MRI, X-ray, or CT imaging of any severity and a medial branch block with local anesthetic that confirms lumbar facet pathology.

Exclusion Criteria:

• Inability to undergo fluoroscopically guided procedures

• Current pregnancy

• Prior spinal surgery with hardware

• Intolerance to local anesthesia, contrast medium, or blood derivatives

• Local or systemic infection or spinal infection

• Irreversible coagulopathy

• Patients that require strict anticoagulation and cannot be off antiplatelet medication for at least a week

• Less than 18 years of age

• Corticosteroid shot within last 3 months into affected lumbar facet joint because of concern of damage to cartilage in the joint in that time period.

• Patients with workman compensation related back pain

• Patients with rheumatic cause of lumbar facet arthritis.

• Patients who have had a radiofrequency neurotomy of the nerves innervating their affected facet joints within the last year

Related Conditions & MeSH terms

• Platelet-Rich Plasma

Intervention

Biological:
• Autologous platelet rich plasma
0.5 mL autologous platelet rich plasma into a symptomatic osteoarthritic lumbar facet to treat back pain caused by lumbar facet syndrome

Locations

Country	Name	City	State
United States	University of Colorado School of Medicine Spine Center	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain Visual Analog Score with back flexion and at rest from baseline after intervention over time.	Pain as assessed from 0-10. Where 10 is severe pain and 0 is no pain. Improvement of pain by 50% after intervention is defined as treatment success	Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention
Primary	PROMIS Survey for Low Back Pain Function (PROMIS-29)	NIH validated PROMIS score for physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, pain interference, and pain intensity (PROMIS- 29 Profile v2.0). A higher PROMIS T-score represents more of the concept being measured.For negatively-worded concepts like Anxiety,a T-score of 60 is one SD worse than average.By comparison,an Anxiety T-score of 40 is one SD better than average.However,for positively-worded concepts like Physical Function-Mobility,a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average.	Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention
Secondary	Length of enrollment of 10 patients and attrition rate	Determine percentage of patients who enroll in the study, how long it takes to enroll 10 patients, and attrition rate of patients in a 3 month time period	3 months
Secondary	Safety as measured by number of subjects with at least one adverse event	Monitoring of adverse events such as bleeding, infection, allergy, neurologic deficits, and injection-related complications.	3 months
Secondary	Degree of improvement in pain and function based on severity of lumbar facet OA.	Using the surveys from the primary outcome, the investigators plan to perform a subgroup analysis depending on the severity of lumbar facet OA as seen by imaging	3 months