Neuropathic lower limb pain Effect of stimulation on neuropathic (nerve) foot pain
Conditions
Interventions
Patients will be randomised to one of the two existing treatments.
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Subject is appropriate for SCS implantation according to standard criteria from the Dutch Neuromodulation Society 2) Subject is 18 to 75 years old 3) Subject is able and willing to comply with the follow-up schedule and protocol 4) Subject has chronic (> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain 5) Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain 6) Subject is able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Subject has no other exclusion criteria for SCS implantation according to standard criteria from the Dutch Neuromodulation Society 2) Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days 3) Subject has had radiofrequency treatment of an intended target DRG within the past 3 months 4) Subject has participated in another clinical study within 30 days 5) Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to compare subject experiences of SCS with the two different therapies. We have defined 4 separate assessment tools, which combined, evaluate the primary endpoint of this study: • Change in perceived stimulation intensity during normal changes in body posture (Standing/Sitting and Lying) • Average number of device activations per day • Assessment (%) of how much of a subject*s painful area is covered by the stimulation induced paraesthesia • Assessment (%) of how much of a subjects non-painful area is also covered by the stimulation induced paraesthesia | — |
Secondary
| Measure | Time frame |
|---|---|
| • Validation of the Paraesthesia Intensity Numerical Rating Scale (PI-NRS) • Foot / Lower Limb Pain Relief (Visual Analogue Scale) • Quality of life (EQ-5D-3L) • Physical functioning (BPI) • Sleep quality (Bespoke scale created specifically for pain patients treated with neurostimulation, currently being validated in other on going studies) • Subject satisfaction (7 Point Likert Scale) • Device safety by monitoring events according to MEDDEV 2.12-1, rev 8 • Pain medication utilisation (Simple notation of current usage through study period) | — |
Countries
Netherlands
Outcome results
None listed