EN- PENS for chronic neuropathic pain (version 1)
Research type
Research Study
Full title
A randomised patient-assessor blinded controlled trial of External\nnon-invasive peripheral nerve stimulation for chronic neuropathic pain\nfollowing peripheral nerve injury (EN-PENS trial).
IRAS ID
197139
Contact name
Selina Johnson
Contact email
Sponsor organisation
The Walton Centre Foundation NHS Trust
ISRCTN Number
ISRCTN53432663
Duration of Study in the UK
3 years, 0 months, 5 days
Research summary
Eight percent of people in the United Kingdom are estimated to have persistent (chronic) neuropathic pain and for many there is no effective treatment. Medications are the most common treatment method but often have limited benefit or unwanted side effects. Surgical treatments such as spinal cord stimulation are then often considered. External non-invasive peripheral nerve stimulation (EN-PNS) is a form of electrical stimulation that involves placing a pen shaped electrode onto the skin, which can be easily self-administered by patients. We have found that EN-PNS can provide significant pain relief for people with localised neuropathic pain, however there is currently no evidence from controlled studies, to support its use within the National Health Service (NHS). \n\nThe study aims to establish whether EN-PNS is effective in reducing pain for people with long-standing neuropathic pain following peripheral nerve injury.\n\nFurther aims are to:\n• assess the benefits to other commonly affected areas such as quality of life and function,\n• assess treatment impact on; mood and symptom report.\n• understand the working mechanisms of EN-PNS\n• assess health economic impact, and whether treatment can help reduce medications and/or avoid surgical interventions\n\nThis is a randomized, controlled trial of EN-PNS. Patients will randomly receive one of two forms of EN-PENS treatment. They will be trained to deliver their own treatment and then continue treatment for 3 months at home. Outcomes will be taken at the start and end of treatment. At the end of treatment phase participants will be offered a 3 month optional treatment extension or switch to the alternative treatment. \nPersons with neuropathic pain have helped develop the study and will also support study management.\nA positive study outcome will be taken forward to support the use of EN-PNS for persons with neuropathic pain within the NHS providing patients with a tool to help manage their pain independently.\n
REC name
North West - Preston Research Ethics Committee
REC reference
16/NW/0273
Date of REC Opinion
29 Apr 2016
REC opinion
Further Information Favourable Opinion