ADjuST study

• Research type

  Research Study

• Full title

  Analgesic efficacy of high density spinal cord stimulation at 1 KHz

• IRAS ID

  179280

• Contact name

  Sam Eldabe

• Contact email

  sam.eldabe@stees.nhs.uk

• Sponsor organisation

  South Tees Hospitals NHS Foundation Trust

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  Spinal Cord Stimulation (SCS) – the electrical stimulation of the spinal cord is a NICE approved therapy due to its documented effectiveness in the relief of neuropathic pain. Conventional SCS produces a pins and needles sensation (paraesthesia) in the painful area of the subject.
  
  Eliciting paraesthesia in the lower back is often challenging and the reliable delivery of ideal stimulation producing paraesthesia coverage of the entire pain area is still difficult to achieve which has led to researchers investigating the advantages and usefulness of providing paraesthesia free pain relief.

  Studies have shown that pain relief can be achieved by using a higher frequency stimulation setting which does not produce paraesthesia. However recent studies seem to indicate that the total amount of charge is more crucial than high frequency alone.

  This 2 phase pilot study is looking to discover if SCS set to high density sub threshold current at 1Khz and 200µ second pulse width can deliver effective pain relief without paraesthesia and improve quality of life of patients with back and/or leg pain.
  
  Phase I: Subjects will be trialled with SCS for 7(+/-4) days. If the subject has a successful trial (>50% pain relief), a full SCS system will be implanted and programmed to deliver a high charge density at sub threshold stimulation. The response will be tested for 14 weeks.

  Phase II: Pulse Width will be reduced by 20% while keeping the current amplitude (1KHz) stable at original setting every 2 weeks until end of study or a point at which the subject declares failure of therapy. At this point the subject’s stimulator will be reverted to the last successful setting at which they reported ≥50% pain relief.

• REC name

  North East - York Research Ethics Committee

• REC reference

  15/NE/0163

• Date of REC Opinion

  22 May 2015

• REC opinion

  Further Information Favourable Opinion