Osteoarthritis, Rheumatoid Arthritis
Conditions
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.
Interventions
None listed
Sponsors
Arizona Pain Specialists
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Rating Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index | 24 week follow up | Total score from the Oswestry Disability Index |
| SF-36 | 24 week follow up | Total score from the SF-36 |
| Pain Medications survey | 24 week follow up | Reduction in reported pain medication usage. |
| Global Pain Scale | 24 week follow up | Levels of pain, emotional health, quality of life, and activities of daily living. |
| Adverse Events | 24 week follow up | Any adverse events between the study procedure and the 24 week follow up will be assessed. |
Countries
United States
Outcome results
None listed