Injections of FloGraft Therapy, Autologous Stem Cells, or Platelet Rich Plasma for the Treatment of Degenerative Joint Pain
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
2 other identifiers
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 7, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedMay 25, 2017
May 1, 2017
3.4 years
November 1, 2013
May 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Numerical Pain Rating Scale
Worst pain in the past 24 hours, from 0 (no pain) to 10 (pain as bad as you can imagine).
24 week follow up
Secondary Outcomes (5)
Oswestry Disability Index
24 week follow up
SF-36
24 week follow up
Pain Medications survey
24 week follow up
Global Pain Scale
24 week follow up
Adverse Events
24 week follow up
Eligibility Criteria
Adults age 18 or older
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arizona Pain Specialists
Scottsdale, Arizona, 85258, United States
Related Publications (7)
Mobasheri A, Csaki C, Clutterbuck AL, Rahmanzadeh M, Shakibaei M. Mesenchymal stem cells in connective tissue engineering and regenerative medicine: applications in cartilage repair and osteoarthritis therapy. Histol Histopathol. 2009 Mar;24(3):347-66. doi: 10.14670/HH-24.347.
PMID: 19130405BACKGROUNDDiaz-Prado S, Rendal-Vazquez ME, Muinos-Lopez E, Hermida-Gomez T, Rodriguez-Cabarcos M, Fuentes-Boquete I, de Toro FJ, Blanco FJ. Potential use of the human amniotic membrane as a scaffold in human articular cartilage repair. Cell Tissue Bank. 2010 May;11(2):183-95. doi: 10.1007/s10561-009-9144-1. Epub 2010 Apr 13.
PMID: 20386989BACKGROUNDPittenger MF, Mackay AM, Beck SC, Jaiswal RK, Douglas R, Mosca JD, Moorman MA, Simonetti DW, Craig S, Marshak DR. Multilineage potential of adult human mesenchymal stem cells. Science. 1999 Apr 2;284(5411):143-7. doi: 10.1126/science.284.5411.143.
PMID: 10102814BACKGROUNDLee KB, Hui JH, Song IC, Ardany L, Lee EH. Injectable mesenchymal stem cell therapy for large cartilage defects--a porcine model. Stem Cells. 2007 Nov;25(11):2964-71. doi: 10.1634/stemcells.2006-0311. Epub 2007 Jul 26.
PMID: 17656639BACKGROUNDWakitani S, Imoto K, Yamamoto T, Saito M, Murata N, Yoneda M. Human autologous culture expanded bone marrow mesenchymal cell transplantation for repair of cartilage defects in osteoarthritic knees. Osteoarthritis Cartilage. 2002 Mar;10(3):199-206. doi: 10.1053/joca.2001.0504.
PMID: 11869080BACKGROUNDSampson 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.
PMID: 21403592BACKGROUNDFilardo 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.
PMID: 20740273BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tory McJunkin, MD
Arizona Pain Specialists
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2013
First Posted
November 7, 2013
Study Start
January 1, 2014
Primary Completion
June 1, 2017
Last Updated
May 25, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share