A Study of Platelet Rich Plasma for the Treatment of Degenerative Joint Disease of the Lumbar Spine
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-004062
Sponsor Protocol Number: 15-004062
About this study
The purpose of this study is to determine the effectiveness and safety of using platelet rich plasma in the treatment of degenerative joint disease in the lumbar spine area.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Clinical and radiographic evidence of symptomatic facet arthropathy involving the bilateral L4-5 and L5-S1 facets
- Positive response, defined as greater than or equal to 75% pain improvement to diagnostic differential medial branch blocks, one block with lidocaine and the other with either bupivacaine or ropivacaine
- Baseline pain greater than or equal to 5 (0-10 scale)
Exclusion Criteria
- Recent facet related procedure
- Intraarticular corticosteroid in last 6-months
- Age < 18 years
- Current opioid use of greater than 100 oral morphine equivalents
- No advanced imaging (MRI or CT) of the lumbar spine within the last 6-months
- BMI > 34.99 (WHO class I obesity)
- Active systemic or local infection
- Anticoagulation with Coumadin with INR > 3.0 or Plavix with less than 7 days on hold
- History of unsuccessful intra-articular injection
- Imaging evidence of high likelihood of failure for intra-articular injection to be determined by a board certified staff radiologist’s review of the fluoroscopic images
- Thrombocytopenia (platelet count less than 50,000)
- Undergoing chemotherapy at time of injection
- Pregnancy secondary to risk of ionizing radiation to the fetus
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Matthew Pingree, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available