Clinical Trial: RFN for SIJ Disease Study

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.


Detailed Summary:
Sponsor: Barts & The London NHS Trust

Current Primary Outcome: Pain Intensity [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain Intensity [ Time Frame: 6 months ]
  • Quality of pain [ Time Frame: 3 and 6 months ]
    Short Form Mcgill Pain Questionnaire
  • Health related Quality of life [ Time Frame: 3 and 6 months ]
    Short form health survey
  • Anxiety and Depression [ Time Frame: 3 and 6 months ]
    Hospital and Depression Scale
  • Functional Disability [ Time Frame: 3 and 6 months ]
    Oswestry Low Back Pain Disability Questionnaire
  • Health related quality of life and quality-adjusted life years [ Time Frame: 3 and 6 months ]
    Euro Quol EQ-5D scale
  • Portion of patients randomised to sham requiring rescue therapy with RFN [ Time Frame: 3 and 6 months ]


Original Secondary Outcome: Same as current

Information By: Barts & The London NHS Trust

Dates:
Date Received: November 11, 2012
Date Started: November 2012
Date Completion:
Last Updated: January 28, 2013
Last Verified: January 2013