Clinical trial NCT01978639: Injections of FloGraft Therapy, Autologous Stem Cells, or Platelet Rich Plasma for the Treatment of Degenerative Joint Pain
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Rheumatoid Arthritis
Lead sponsor: Arizona Pain Specialists
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults age 18 or older

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older,
* Ability to complete follow-up visits,
* Able to understand the study protocol and provide consent,
* Significant pain (average pain in the past month greater than or equal to 5, from 0-10),
* Pain lasting at least 3 months,
* Pain associated with one of the following conditions: lumbar facet degeneration, - OR -degenerative condition causing upper extremity joint pain, - OR - degenerative condition causing lower extremity joint pain.

Exclusion Criteria:

* Current litigation or worker's compensation claim,
* Unstable pain medication dosage,
* Previous surgery at the affected site,
* Injections at the affected site within the past 6 months,
* Uncontrolled psychiatric condition,
* Pregnancy or lactating in women,
* History of adverse reactions to local anesthetic

Primary outcomes:
measure: Numerical Pain Rating Scale
timeFrame: 24 week follow up
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: 24 week follow up
measure: SF-36
timeFrame: 24 week follow up
measure: Pain Medications survey
timeFrame: 24 week follow up
measure: Global Pain Scale
timeFrame: 24 week follow up
measure: Adverse Events
timeFrame: 24 week follow up
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Pain Specialists
state: Arizona
Study officials:
affiliation: Arizona Pain Specialists
name: Tory McJunkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Sampson S, Reed M, Silvers H, Meng M, Mandelbaum B. Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. Am J Phys Med Rehabil. 2010 Dec;89(12):961-9. doi: 10.1097/PHM.0b013e3181fc7edf.
citation: Filardo G, Kon E, Buda R, Timoncini A, Di Martino A, Cenacchi A, Fornasari PM, Giannini S, Marcacci M. Platelet-rich plasma intra-articular knee injections for the treatment of degenerative cartilage lesions and osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2011 Apr;19(4):528-35. doi: 10.1007/s00167-010-1238-6. Epub 2010 Aug 26.