Chronic neuropathic pain Nervous System Diseases Disorders of autonomic nervous system
Conditions
Interventions
Three 5-minute treatment sessions of external peripheral neuromodulation at 2 Hz (or sham stimulation) at weekly intervals. Follow-up to 7 days after the last session, i.e. 21 days.
Sponsors
Guy's and St Thomas' NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient age is 18 years or older, either sex 2. Patient has chronic neuropathic (or predominantly neuropathic) intractable pain 3. Patient has an area of pain with a typical dermatomal distribution that can be expected to be covered with a single episode of local stimulation 5. In the opinion of the Investigator and the patient's consultant, all standard medical options have been tried without sufficient improvement in pain control (including opioids, nerve blocks, etc.) 6. Patient has a Visual Analogue Scale (VAS) pain score of 5 cm (or greater) on a 10 cm line
Exclusion criteria
Exclusion criteria: 1. Patient has a history of substance abuse or substance dependency in the past 6 months prior to baseline data collection 2. Patient is currently participating in another clinical study 3. Patient lacks capacity for informed consent to the trial in the view of person taking consent and/or investigators 4. Pregnancy - if the painful area lies within 50 cm of the gravid uterus 5. Patient has difficulties in adequate understanding of English for consent, clinical review and self-completion questionnaires 6. Patient does not permit notification to General Practitioner of enrolment in the study 7. Patient has previous experience of peripheral neuromodulation. Note that prior transcutaneous electrical nerve stimulation (TENS) experience is permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Score (VAS) of pain severity one week following third (final) neuromodulation session. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. VAS of pain severity immediately after treatment and at 7 day intervals to end of study (i.e., days 7, 14 and 21) 2. VAS of pain severity at shorter intervals of less than a week 3. Numerical rating scores (NRS) of: 3.1. Sleep quality 3.2. Functional impact 3.3. Emotional impact Measured at 7 days following third (final) neuromodulation session. 4. Numerical rating scores on Pain Self-Efficacy Questionnaire (PSEQ) at 7 days following third (final) neuromodulation session 5. Changes in medication usage 6. Change in size of painful area on pain/paraesthesiae map | — |
Countries
United Kingdom
Outcome results
None listed