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Completed

NCT Number: NCT04522674

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

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.

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Key information

Conditions

Platelet-Rich Plasma

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Colorado School of Medicine Spine Center

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Platelet Rich Plasma

Biological

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

Primary outcomes

  1. Change in pain Visual Analog Score with back flexion and at rest from baseline after intervention over time.

    Time frame: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention

    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

  2. PROMIS Survey for Low Back Pain Function (PROMIS-29)

    Time frame: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention

    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.

Secondary outcomes

  1. Length of enrollment of 10 patients and attrition rate

    Time frame: 3 months

    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

  2. Safety as measured by number of subjects with at least one adverse event

    Time frame: 3 months

    Monitoring of adverse events such as bleeding, infection, allergy, neurologic deficits, and injection-related complications.

  3. Degree of improvement in pain and function based on severity of lumbar facet OA.

    Time frame: 3 months

    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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 21, 2020
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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