Lower Back Pain, Facets Joints Osteoarthritis Clinical Trial
Official title:
Safety and Efficacy of ExAblate MR Guided Focused Ultrasound for the Treatment of Low Back Pain Related to Facet Joint Osteoarthritis
Chronic pain affects an estimated 50 to 65 million individuals in the US, and its incidence
and prevalence is steadily on the rise in correspondence with the increasing longevity of
the population. Spinal pain, encompassing lower back, thoracic and neck pain, is a very
common type of chronic pain that can greatly reduce quality of life. Facet joint pain is
most often associated with facet arthropathy or degenerative arthritis of the joint. This
condition develops due to progressive wear and tear caused by the small but repetitive
strain of the joints throughout a lifetime. Strain and inflammation can induce fluid
distention of the joints which in turn can result in compression of the nerve roots of the
joint - the origin of the chronic pain.
Current treatments for facet arthropathy and pain include oral medications, intra-articular
injections of anesthetic or steroid medications, energy ablation (e.g. radiofrequency
ablation) for denervation, and in some severe cases facet rhizotomy (surgical severing of
the nerves).
The ExAblate magnetic resonance guided focused ultrasound system enables noninvasive focal
ablation of tissue. Results from feasibility studies, including those from the FDA approved
feasibility study (IDE # G050177) have shown the palliative effect of the ExAblate for
patients with bone metastases. It is reasonable to assume that this palliative effect of
MRgFUS could also translate to the alleviation of facet pain if focused ultrasound beams are
directed to the facet joints. The highly-target focal ablation could also diminish the risk
of complications that are often associated with other less selective denervation techniques.
The objective of this trial is to evaluate the safety and effectiveness of the ExAblate
system and the treatment of pain resulting from facet joint osteoarthritis.
This is a prospective, non-randomized, single-arm, phase I study to evaluate the safety and
effectiveness of using ExAblate MRgFUS in the treatment of pain resulting from facet joint
osteoarthritis.
Patients with chronic LBP associated with one or more lumbar zygapophysial joints that meet
all eligibility requirements and have given their written informed consent will be enrolled
to the study.
All patients will be treated and followed for 12-months post treatment. A total of 50
patients will be enrolled at up to two clinical sites.
The primary objective of this study is to evaluate incidence and severity of adverse events
associated with the ExAblate MRgFUS system used for the treatment of pain resulting from
facet joint osteoarthritis
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment