Neuropathic pain following peripheral nerve injury Nervous System Diseases Neuropathic pain following peripheral nerve injury
Conditions
Interventions
Patients will be randomised to receive one of two forms of EN-PENS treatment (xavant stimpod NMS460 or control) by an independent randomisation service via an online system based at the King’s Clinica
this will produce a lower current density/intensity not activating small fibres. The display will appear to allow patients the same freedom to increase stimulation on both machines to 30mA
however the control de
Sponsors
The Walton Centre NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chronic neuropathic pain following peripheral nerve injury, definite or probable: 1.1. Pain with a distinct neuroanatomically plausible distribution 1.2. A history suggestive of a relevant lesion or disease affecting the peripheral or central somatosensory system 1.3. Demonstration of the distinct neuroanatomically plausible distribution by at least one confirmatory test 1.4. Demonstration of the relevant lesion or disease by at least one confirmatory test Grading of certainty for the presence of neuropathic pain: definite neuropathic pain: all (1 to 4); probable neuropathic pain: 1 and 2, plus either 3 or 4 (Treede, Jensen et al. 2008) 2. At least 12 months duration of neuropathic pain symptoms 3. Adults age 18 years or above 4. Moderate to severe pain intensity (Average 24 hour pain intensity over 7-days at baseline of = 5/10 but not dropping below 4 on any single day, on an 11-point (0-10) numerical rating scale (NRS)) 5. Pain localised to the distribution of 1-2 peripheral nerves 6. Distribution of pain that will allow for the nerve to be stimulated proximally from the areas of pain. 7. Discontinuation of numbing pain medications (lidocaine patches 4 weeks prior, Capsaicin 4 months prior) 8. Patients should have trialed first line pharmacotherapy (First-line treatment include either tricyclic antidepressants or serotonin-noradrenaline reuptake inhibitors, pregabalin or gabapentin) 9. Moderate- severe brush stroke allodynia (Defined as pain of = 5/10 on an 11-point (0-10) numerical rating scale (NRS), when brush stroke is applied to the affected area (average of 3 strokes over affected area)) 10. Willing to not commence any new medications/ treatments for their neuropathic pain whilst involved in the trial 11. Women of childbearing potential may participate providing they are using adequate birth control methods for the duration of the trial (including accepted methods of contraception such as; barrier methods, intrauterine device IUD, contraceptive implant, depot injection, oral contraception and abstinence (as part of lifestyle choice))
Exclusion criteria
Exclusion criteria: 1. Absolute numbness within area of pain (suggests sufficient nerve damage to render EN-PNS unlikely to work) 2. Known EN-PNS contraindications (pregnancy and cardiac pacemakers)* 3. Other chronic pains or unstable medical conditions, which in the opinion of the investigator would make the trial unsuitable for the patient 4. Unstable pain intensity or pain medications 6 weeks prior to the study that in the judgement of the PI would interfere with assessment of outcome 5. Persons participating in an interventional trial within the past 3 months 6. Persons participating in a non-interventional trials completed within 2 weeks prior to start of the trial 7. Diagnosed psychiatric or mental health disorder which in the judgment of the PI interferes with successful study participation 8. Inability to comply with the study protocol for the trial-period of 3 months 9. Inability to complete outcome measures 10. Incapacity to understand the information necessary to provide informed consent 11. Other implanted device for the same pain complaints such as spinal cord stimulation (SCS) 12. Phantom Limb pain** *Non pregnancy confirmed by urine test at baseline and at treatment end **Stump pain can be treated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average 24 hour pain intensity recorded on an 11-point (0-10) numerical rating scale, averaged over the last 7 days of the 3 month home-loan period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life is measured using the EuroQOL-5D-5L questionnaire at baseline, 1, 2 and 3 months and end of where applicable end of optional treatment extension/swap (6 months) 2. Physical function will be assessed using the Brief Pain Inventory questionnaire interference subscale at baseline and 3 months Exploratory Outcomes: 1. Emotional functioning is measured on the Hospital Anxiety and Depression Scale questionnaire at baseline and 3 months 2. Perceived control in terms of confidence in being able to perform day to day tasks despite pain is measured using the pain self-efficacy questionnaire at baseline and 3 months 3. Surface area of allodynia is measured in cm2 using a brush to identify the boundaries of the affected area (a washable marker pen will mark an outline of the boundaries and this will be traced onto clear plastic acetate) at baseline and 3 months 4. The intensity of allodynia will be measured on a numerical rating scale (NRS), as the average of 3 strokes across the allodynic area, during study screening 5. Quality of pain is measured using the neuropathic pain symptom inventory (NPSI) questionnaire at baseline and 3 months 6. A specially designed optional sensory test will be conducted for patients who consent to this at 3 months which will help aid understanding of the working mechanisms of treatment 7. Health economic analysis – will be conducted using self-reported measures of health care utilisation and EuroQOL-5D-5L at baseline and 3 months 8. Potential medical suitability for invasive NeuroModulation will be determined by review of case notes and clinic letters by a pain and neuromodulation consultant | — |
Countries
England, United Kingdom
Contacts
Public ContactSelina Johnson
Outcome results
None listed