Injections of FloGraft Therapy, Autologous Stem Cells, or Platelet Rich Plasma for the Treatment of Degenerative Joint Pain
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|ClinicalTrials.gov Identifier: NCT01978639|
Recruitment Status : Active, not recruiting
First Posted : November 7, 2013
Last Update Posted : May 25, 2017
|Condition or disease|
|Osteoarthritis Rheumatoid Arthritis|
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:
- A single injection of Applied Biologics' FloGraftTM.
- A single injection of autologous bone marrow derived stem cells.
- 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|
|Estimated Enrollment :||300 participants|
|Official Title:||Outcomes of Single Injections of FloGraft Therapy, Autologous Stem Cells, or Platelet Rich Plasma for the Treatment of Pain in the Lumbar Facet Joints, Sacroiliac Joints, Upper Extremity Joints, and Lower Extremity Joints|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||June 2017|
- Numerical Pain Rating Scale [ Time Frame: 24 week follow up ]Worst pain in the past 24 hours, from 0 (no pain) to 10 (pain as bad as you can imagine).
- Oswestry Disability Index [ Time Frame: 24 week follow up ]Total score from the Oswestry Disability Index
- SF-36 [ Time Frame: 24 week follow up ]Total score from the SF-36
- Pain Medications survey [ Time Frame: 24 week follow up ]Reduction in reported pain medication usage.
- Global Pain Scale [ Time Frame: 24 week follow up ]Levels of pain, emotional health, quality of life, and activities of daily living.
- Adverse Events [ Time Frame: 24 week follow up ]Any adverse events between the study procedure and the 24 week follow up will be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978639
|United States, Arizona|
|Arizona Pain Specialists|
|Scottsdale, Arizona, United States, 85258|
|Principal Investigator:||Tory McJunkin, MD||Arizona Pain Specialists|