High Frequency Ultrasound (HiFU) Study
Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain (ClinicalTrials.gov Identifier: NCT05154448)
The Ainsworth Institute is participating in a Phase III Clinical Trial studying the safety and potential efficacy of using high-frequency ultrasound (HiFU) to treat chronic low back pain. There are many potential causes for low back pain, one of the most common causes is the facet joint – the joint hear and feel when we crack our backs. The facet joint can become arthritic like any other joint in the body and lose cartilage causing the bony surfaces to grind…thus causing inflammation and pain. This study will examine using high frequency ultrasound to treat low back pain caused by damaged/painful facets.
Low Back Pain
Nine out of 10 Americans will experience back pain in their lives and it is the 5th most common cause for a visit to the doctor. Severe back pain can become so debilitating that simple tasks such as bending down to pick something up or walking to the store can become next to impossible. Luckily, there are many treatment options available to help you get back to feeling more like you.
The joints of the spine are called “facets” – these are what you hear popping when you crack your back or neck. These joints can develop arthritis like any other joint in the body. This is an extremely common cause for back pain and is completely irreversible. Patients with facet-related pain will typically have back pain that gets worse with standing up, is centered across the low back and does not shoot down the leg.
Traditionally, there are only a handful of treatments for facet-related pain:
Once a facet becomes damaged or arthritic, it will stay that way…indefinitely. Currently, the most effective treatment for low back pain coming from damaged/arthritic facets is an RFA: using radio wave-energy from the tip of special needles to stun the nerves of the facet to block the pain signals. As effective as this treatment is, it doesn’t last forever as the nerves will grow back after 6-18 months, and along with that comes the pain. That means the procedure needs to be repeated periodically.
But what if the procedure could be performed WITHOUT the use of a needle? What if the nerves could be ablated using focused ultrasound energy instead of needing a needle? That way, whenever the nerves grow back, you could get the procedure repeated in much less invasive way. Well, that is exactly what this clinical trial is studying: focusing high frequency ultrasound energy at the facet nerves (aka medial branches) to ablated them…similar to the idea of a gamma knife.
This clinical trial is a prospective, multi center study focusing on whether or not high frequency ultrasound is an effective means of treating low back pain coming from damaged/arthritic facets.
This study is registered with ClinicalTrials.gov.
THIS STUDY IS ACTIVELY RECRUITING PATIENTS AS OF September 1st, 2022
Details of the Study
Patients who qualify for the study will be randomized to receive either High Intensity Focused Ultrasound Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XR High Intensity Focused Ultrasound device or a sham procedure. All costs for the study are covered by the study sponsor.
Study Enrollment Form
Official Protocol Name: Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain
Get Answers to Your Questions at the Ainsworth Institute
The key to finding the proper treatment for any type of pain is getting a proper diagnosis. Not all types of pain respond to the same treatments and the window for improvement can be limited. The experts at Ainsworth Institute offer the most advanced pain management treatments available today, including advanced clinical trials that aren’t yet available to the general public. Call us today for an appointment so we can get you started on your road to recovery.