Autonomic tone study in painful diabetic neuropathy
Research type
Research Study
Full title
Prospective, open label, single site pilot study to assess the effects of spinal cord stimulation on autonomic function in patients with painful diabetic neuropathy
IRAS ID
324761
Contact name
Sheila Black
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Diabetes mellitus can damage nerves in the body, including those in the feet and legs. Pain can arise when this happens and it is called painful diabetic neuropathy (PDN). It can manifest as a burning, excruciating, stabbing or intractable type of pain or present with tingling or numbness.
In the UK, the National Institute for Health and Care Excellence recommends spinal cord stimulation (SCS) as a treatment for chronic nerve-related pain. SCS is a minimally invasive therapeutic option that involves implanting a device that delivers mild electrical signals to the spinal cord to reduce pain. Recent studies have shown that SCS can reduce pain and improve reflexes, sensation and motor strength in PDN. This pilot study will measure nerve activity, blood flow, pain, quality of life and symptoms in individuals with PDN before and after SCS.
The target sample is 10 participants with PDN with recordable measurements of nerve activity at all four study visits. Participants will attend an initial visit prior to having the device implanted. They will have their heart rate, blood pressure, breathing and nerve activity recorded and be asked to complete a number of questionnaires. They will then return at 3-months, 6-months and 12-months after having the device implanted.
REC name
North of Scotland Research Ethics Committee 1
REC reference
23/NS/0090
Date of REC Opinion
3 Sep 2023
REC opinion
Favourable Opinion