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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
Sponsor:
Information provided by (Responsible Party):
Arizona Pain Specialists

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.

Condition or disease
Osteoarthritis Rheumatoid Arthritis

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.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: 24 week follow up ]
    Total score from the Oswestry Disability Index

  2. SF-36 [ Time Frame: 24 week follow up ]
    Total score from the SF-36

  3. Pain Medications survey [ Time Frame: 24 week follow up ]
    Reduction in reported pain medication usage.

  4. Global Pain Scale [ Time Frame: 24 week follow up ]
    Levels of pain, emotional health, quality of life, and activities of daily living.

  5. Adverse Events [ Time Frame: 24 week follow up ]
    Any adverse events between the study procedure and the 24 week follow up will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults age 18 or older
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

Information from the National Library of Medicine

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


Locations
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United States, Arizona
Arizona Pain Specialists
Scottsdale, Arizona, United States, 85258
Sponsors and Collaborators
Arizona Pain Specialists
Investigators
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Principal Investigator: Tory McJunkin, MD Arizona Pain Specialists

Publications:

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Responsible Party: Arizona Pain Specialists
ClinicalTrials.gov Identifier: NCT01978639     History of Changes
Other Study ID Numbers: APS 2013-022
2013-022 ( Other Identifier: Scottsdale Healthcare IRB )
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases