TRIUMPH

• Research type

  Research Study

• Full title

  MulTi-center pRospectIve stUdy deterMining the sustainability of Pain relief and psychosocial and functional responses wHen utilizing a multiple waveform enabled neurostimulator

• IRAS ID

  221636

• Contact name

  Abdul Lalkhen

• Contact email

  abdul.lalkhen@srft.nhs.uk

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  This study is for implantable medical device treatment of patients with pain of the trunk and/or limbs. It will study the effects of electrical stimulation of the spine to suppress pain.
  The sponsor is interested in collecting data to evaluate stimulators that can stimulate with a tonic or Burst waveform (multiple waveform enabled stimulators). The goal is to collect data on pain relief, patient pain feelings, patient daily activities, the settings that their physician has programmed and how the patients use the device. With these data, the sponsor will be able to evaluate the quality and the performance of the device and it will give a better understanding of chronic pain.

  Some of the actions/data collection that will be done in this study are part of the normal care and would be done even if the patient were not in the study.

  The study will last 4 years - two years inclusion period and two years follow-up.

  Enrolment will stop when 267 participants have received devices.

  The patient visits will be enrolment, implant, 3, 6, 12, 18 and 24 month follow-ups.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  17/YH/0085

• Date of REC Opinion

  3 Jul 2017

• REC opinion

  Further Information Favourable Opinion