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More info
You can access this
clinical trial
if you have
Sacro Iliac Joint Pain
and you are
between 18 and 80
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The purpose

The purpose of the study is to investigate if a technique called Simplicity III® Radiofrequency Neurotomy is effective in improving the management of sacroiliac joint pain. Currently there are a variety of treatments for managing this pain but there is still some doubt as to which treatments are the most effective. Simplicity III® is one such treatment for sacroiliac joint pain and has been used in the NHS for many years. It uses electrical current to generate heat around the tip of the needle placed close to the nerves that supply the sacro-iliac joint. This heat ablates the specific nerves supplying the joint and improves pain. The traditional method used to treat this type of pain uses multiple injections to target the nerves supplying the joint. This method is however both time consuming and the results are variable depending upon the number of injections. Therefore a new electrode, called the Simplicity III®, was developed to allow the treatment to be undertaken using fewer injections. Although this treatment has received formal approval, undergone conformity assessment and is available in certain specialist NHS centres for clinical use, there is presently limited evidence with regards to its clinical efficacy. We wish to test the effectiveness of this new device in treating sacroiliac joint pain. The best way to prove the clinical effectiveness is to compare Simplicity III® against an identical procedure where the electrode is not switched on and neither the patient nor the doctor is aware whether it was switched on. Once pain has been assessed at 3 months, those patients not receiving active treatment and remaining in pain will be offered the active treatment.

Provided treatments

  • Procedure: Comparison of active versus sham radiofrequency neurotomy with Simplicity III

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01726608. The sponsor of the trial is Barts & The London NHS Trust and it is looking for 30 volunteers for the current phase.
Official trial title:
A Sham, Controlled, Randomised Trial to Investigate the Effects of Radiofrequency Neurotomy Using Simplicity III® on Patients With Sacroiliac Joint Pain.