Sacro Iliac Joint Pain Clinical Trial
Official title:
A Sham, Controlled, Randomised Trial to Investigate the Effects of Radiofrequency Neurotomy Using Simplicity III® on Patients With Sacroiliac Joint Pain.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment