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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Barts Health NHS Trust
London, United Kingdom
Pain Intensity
Time frame: 3 months
Pain Intensity
Time frame: 6 months
Quality of pain
Short Form Mcgill Pain Questionnaire
Time frame: 3 and 6 months
Health related Quality of life
Short form health survey
Time frame: 3 and 6 months
Anxiety and Depression
Hospital and Depression Scale
Time frame: 3 and 6 months
Functional Disability
Oswestry Low Back Pain Disability Questionnaire
Time frame: 3 and 6 months
Health related quality of life and quality-adjusted life years
Euro Quol EQ-5D scale
Time frame: 3 and 6 months
Portion of patients randomised to sham requiring rescue therapy with RFN
Time frame: 3 and 6 months
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