PENTAGONS
Research type
Research Study
Full title
Diabetic Peripheral Neuropathy Treatment with Dorsal Root Ganglion Stimulation – a Randomised Controlled Trial.
IRAS ID
226499
Contact name
James FitzGerald
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
40062191
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
A common complication of diabetes is damage to the nerves in the limbs, known as diabetic neuropathy. This often causes pain, commonly in the feet. Pain can be severe, and may not be adequately controlled by medication.
This study will evaluate a treatment called Dorsal Root Ganglion Stimulation (DRGS) for painful diabetic neuropathy (PDN) of the feet. In DRGS, we implant a system that delivers small electrical current pulses to stimulate the nerves that are carrying pain signals from the feet at the point where they enter the spine. At this point there is a small swelling on the nerve called the dorsal root ganglion and it is this that is stimulated. DRGS has proved effective for similar types of pain in the lower limbs that is due to other causes.
Implantation is performed in two stages: first, wires are inserted into the low back through hollow needles. Each wire tip is positioned in contact with a dorsal root ganglion. Second, the wires are connected to a pulse generator implanted just under the skin, which contains a battery and electronics to generate stimulus pulses, similar to a heart pacemaker.
People with severe PDN that is not adequately controlled by medication will be invited to participate in this study. After a baseline assessment of pain levels and quality of life, participants will be randomly assigned to either undergo insertion of a dorsal root ganglion stimulator system, or continue on treatment with medication alone. We will reassess the participants' pain levels and quality of life over the following 6 months to see if DRGS is effective in treating PDN.
In a subset of participants we will also perform physiological tests to examine the effects of DRGS on nerve function and blood flow, which are both abnormal in PDN.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
18/SC/0146
Date of REC Opinion
9 May 2018
REC opinion
Further Information Favourable Opinion