PENTAGONS
Diabetic PEripheral Neuropathy Treatment with dorsAl Root GangliON Stimulation – a Randomised Controlled Trial.
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.
If you have severe foot pain due to your diabetes that has not responded well to painkillers, you may be eligible to take part. If you would like to be considered please contact pentagons.recruitment@nds.ox.ac.uk. We will go through some simple screening questions with you and can then arrange for you to be seen at your nearest trial centre.