PROCO

• Research type

  Research Study

• Full title

  Evaluation of Stimulation Pulse Rate on Clinical Outcomes in Patients whose Pain is Controlled by 10KHz Frequency – A Feasibility Study

• IRAS ID

  156681

• Contact name

  Simon Thomson

• Contact email

  simon.thomson@btuh.nhs.uk

• Sponsor organisation

  Basildon & Thurrock University Hospital NHS Trust

• Clinicaltrials.gov Identifier

  CCT-NAPN-24893, ISRCTN

• Duration of Study in the UK

  0 years, 11 months, 30 days

• Research summary

  The study is a multi-center, randomized feasibility study. In this design, eligible subjects with good response to 10KHz Spinal Cord Stimulation will receive randomized rates of 500Hz, 1KHz, 5KHz and 10KHz.
  It is designed to identify if the stimulation frequency (within the above range) has any effect on the clinical outcomes of Spinal Cord Stimulation (SCS) and if so, predict the optimal lower stimulation frequency in patients whose pain is successfully treated by 10Khz stimulation as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.
  Boson Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology will be used for the study.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  14/EE/1138

• Date of REC Opinion

  21 Apr 2015

• REC opinion

  Further Information Favourable Opinion