NCT01726608

RFN for SIJ Disease Study

A Sham, Controlled, Randomised Trial to Investigate the Effects of Radiofrequency Neurotomy Using Simplicity III® on Patients With Sacroiliac Joint Pain.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Barts & The London NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sacro Iliac Joint Pain

Interventions

Type	Name	Description
PROCEDURE	Comparison of active versus sham radiofrequency neurotomy with Simplicity III

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-11-15
• Last updated: 2024-11-05

Locations

1 site across 1 country: United Kingdom