This study will assess the outcomes of three currently available regenerative treatments (FloGraft, autologous stem cell therapy, platelet rich plasma therapy) for painful degenerative conditions of the joints. Patients receiving one these treatments will be assessed before the treatment procedure and followed up at four points over the six months after their procedure. Patients' pain, quality of life, and pain medication use at follow up will be compared to baseline levels. The investigators hypothesize that all three treatments will be effective in reducing pain, improving quality of life, and reducing pain medication usage.
This is an open-label, non-randomized study assessing the efficacy of three potentially regenerative treatments for degenerative conditions of the joints of the lower back (facet, sacroiliac), upper extremities (e.g., shoulder), and lower extremities (e.g., hip, knee). These treatments are: 1. A single injection of Applied Biologics' FloGraftTM. 2. A single injection of autologous bone marrow derived stem cells. 3. A single injection of platelet rich plasma. Subjects will be assessed prior to treatment for their level of pain, quality of life, and pain medication usage. Subjects will be followed up at 4 weeks, 8 weeks, 12 weeks, and 24 weeks after treatment. At each of these follow up visits, pain, quality of life, and pain medication usage will be assessed. The investigators hypothesize that all three treatment groups will experience reduced pain, improved quality of life, and reduced pain medication usage at follow up.
Study Type
OBSERVATIONAL
Enrollment
300
Arizona Pain Specialists
Scottsdale, Arizona, United States
Numerical Pain Rating Scale
Worst pain in the past 24 hours, from 0 (no pain) to 10 (pain as bad as you can imagine).
Time frame: 24 week follow up
Oswestry Disability Index
Total score from the Oswestry Disability Index
Time frame: 24 week follow up
SF-36
Total score from the SF-36
Time frame: 24 week follow up
Pain Medications survey
Reduction in reported pain medication usage.
Time frame: 24 week follow up
Global Pain Scale
Levels of pain, emotional health, quality of life, and activities of daily living.
Time frame: 24 week follow up
Adverse Events
Any adverse events between the study procedure and the 24 week follow up will be assessed.
Time frame: 24 week follow up
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