Have you experienced moderate to severe lower back pain due to Osteoarthritis?
We are currently enrolling patients in a new clinical study for lower back pain due to facet joint osteoarthritis. In this study, a tiny amount of an injectable treatment is placed in the facet joint, which may help reduce pain associated with facet joint osteoarthritis.
If you have inadequate pain relief from simpler treatments, please reach out to us in Napa at Neurovations Research. We are the region’s most experienced clinical research facility for pain.
If accepted for this study, you will receive free study-related medical care.
To see if you qualify, call Neurovations at 707-252-9606 or click on the link below to email us.
Neurovations Research, founded in 2010, is at the forefront of innovation in the field of pain and neuromodulation. CEO and founder Dr. Eric Grigsby has led clinical trials with more than fifty companies, partnering with industry leaders and early-stage companies in medical device (Phase I-IV) and pharmaceutical trials (Phase II-IV), including first-in-man medical device trials, double-blinded and placebo-controlled trials.
Our patient-centered approach creates success in rapid enrollment and quality trial management. Our investigator training facility helps us provide an unparalleled synergy of clinical research capabilities for pain management and neuroscience trials.
What is facet joint osteoarthritis?
Facet joint osteoarthritis is the breakdown of cartilage between the facet joints. When the joints move, the lack of cartilage causes pain as well as loss of motion and stiffness. If you are experiencing lower back pain from osteoarthritis, continue reading to see if you qualify for the study.
Do I qualify for this study?
Are you:
- Experiencing lower back pain due to Osteoarthritis with moderate to severe symptoms?
- Between the ages of 18 & 90?
- Finding your lower back pain is made worse by activity or movement?
How long will the study take?
If you agree to take part, and you meet the study requirements, your participation in the study is expected to last up to approximately 7 months.
This includes:
- A screening visit (scheduled 30 days before dosing visit)
- 1 study dosing visit (approx 8 hours)
- 8 follow-up visits at the same study site
Osteoarthritis is a common degenerative joint disease that can cause severe pain and disability in adults. Due to the breakdown of cartilage between the facet joints, there is increased friction between joints. This makes movement of these joints painful, causing the following symptoms:
- Stiffness
- Loss of motion
- Muscle spasms
- Tingling
- Numbness
- Lower back pain
Currently, facet joint pain can be treated with an injection of lignocaine/lidocaine directly into the joint and known as a facet block. Facet block is done to relieve pain and may also help determine if the facet joints are the source of the individual’s pain. Physical therapy, topical anti-inflammatory medication, and corticosteroid injection can also be used to treat joint pain.
Who is unable to take part in this study?
Unfortunately, if you meet any of the following, this study is not the right fit for you:
- People who are allergic to lidocaine/lignocaine
- People who have a scheduled surgery to joints in the next 6 months
- People who are currently being treated with an immunosuppressant such as prednisone (greater than 10mg/day), anticoagulants, antibiotics or antivirals
- People who are currently receiving chemotherapy
What is the purpose of this study?
This research project is investigating a potential new treatment that will evaluate an experimental treatment product called XT-150, which may eventually be used for the treatment of pain caused by facet joint osteoarthritis. The main purpose of this study is to assess the safety, tolerability, and efficacy of the experimental treatment.