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Diabetic PEripheral Neuropathy Treatment with dorsAl Root GangliON Stimulation – a Randomised Controlled Trial.

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Summary 

Participants are patients with medication-resistant severe pain due to peripheral diabetic neuropathy (PDN) affecting the feet.

Background 

  • Painful diabetic neuropathy (PDN) is a common clinical problem.
  • Around 50% of diabetics have PDN with 11-30% experiencing neuropathic pain.
  • Medication such as tricyclic antidepressants, SSRIs, anticonvulsants and opiates are the usual treatment. For a large number this is unsatisfactory due to inadequate pain relief and/or severe side effects.
  • However the pain in some patients may respond to neuromodulation.
  • Two RCTs of Spinal Cord Stimulation (SCS) for PDN have found responder rates (i.e. the proportion of patients whose pain is reduced by 50% or more) of 60%. Despite this its use has not become widespread.
  • Painful diabetic neuropathy (PDN) is a common clinical problem.
  • Around 50% of diabetics have PDN with 11-30% experiencing neuropathic pain.
  • Medication such as tricyclic antidepressants, SSRIs, anticonvulsants and opiates are the usual treatment. For a large number this is unsatisfactory due to inadequate pain relief and/or severe side effects.
  • However the pain in some patients may respond to neuromodulation.
  • Two RCTs of Spinal Cord Stimulation (SCS) for PDN have found responder rates (i.e. the proportion of patients whose pain is reduced by 50% or more) of 60%. Despite this its use has not become widespread.

Aims and objectives

Primary outcome measure:

  • To establish the efficacy of DRGS for pain relief in Painful Diabetic Neuropathy of the feet. Percentage of patients obtaining at least 50% reduction in pain visual analogue scale (VAS) score at 30 weeks post randomisation, compared to baseline pre-randomisation values.

Secondary outcomes include:

  • Quality of life
  • Healthcare Economic Effects 
  • Medication use
  • Physiological effects (sub-study)
  • Safety

Measures are all PROMS via the use of a resource use diary and Questionnaires at Baseline, 8,18 and 30 weeks.

Study design

  • Randomised open label, multi-centre, two-arm trial of Dorsal Root Ganglion Stimulation (DRGS) versus continued medical management (CMM)
  • DRGS device is CE marked
  • Planned Sample Size 56 randomised (28 in surgery arm and 28 in continued medical management arm (CMM)) 20-24 of the patients in the main trial (10-12 DRGS and 10-12 CMM) at the lead centre will additionally be recruited into a sub study examining the physiological effects of DRGS in this patient population.