Effect of Pulsed RF treatment of dorsal root ganglion on fMRI

• Research type

  Research Study

• Full title

  Assessing the effect of 'pulsed radiofrequency(PRF) treatment of dorsal root ganglion on functional magnetic resonance imaging(fMRI)' in patients with chronic sciatica

• IRAS ID

  132422

• Contact name

  Sam Eldabe

• Contact email

  seldabe@mac.com

• Sponsor organisation

  South Tees Hospitals NHS Foundation Trust

• Research summary

  The incidence of continuing back and leg pain following spinal surgery (Failed Back Surgery Syndrome - FBSS)is 10-40% with more often no clear surgical solution. Conventional management of chronic leg pain includes medication, physiotherapy epidural steroid injections. Epidural steroid injections are not very effective and not without risk. Pulsed Radio Frequency (PRF) is used in this condition to provide pain relief which may be more effective with fewer side effects and a less invasive alternative to surgical intervention which may involve significant morbidity.
  This study aims to find the effect of pain relief on areas of the brain handling thought and sensation using functional magnetic resonance imaging (fMRI), a non-invasive medical test. fMRI uses magnetic resonance imaging to measure the tiny metabolic changes that take place in an active part of the brain. fMRI is becoming the diagnostic method of choice for learning how a normal, diseased or injured brain is working.

  After initial assessment we will recruit 16 male patients in the age group of 18-65years with FBSS and pain lasting 2-5 years with no contraindication for magnetic resonance imaging. Informed consent for PRF treatment and fMRI will be obtained from the selected participants. Participants will undergo two pre procedure fMRI scans - one mock fMRI at Durham University and one active fMRI at James Cook University Hospital (JCUH). Following this, they will undergo PRF treatment at day surgery unit at JCUH. Further visit will be arranged two weeks post procedure for post procedure fMRI and assessment of pain relief.

  Outcomes measure:
  Primary- Correlation of changed pain rating with changes in affective and sensory pain components in the brain as evidence by fMRI.
  Secondary – Pain reduction assessed with Visual Analogue Score and quality of life (EQ-5D) questionnaire.

• REC name

  North East - York Research Ethics Committee

• REC reference

  13/NE/0234

• Date of REC Opinion

  27 Sep 2013

• REC opinion

  Further Information Favourable Opinion