Chronic pain leg pain sciatica
Conditions
Interventions
All subjects will be stimulated with both standard forms of spinal cord
stimulation: Low Frequency (LF-SCS) at 30Hz and High Frequency (HF-SCS) at
1000Hz, with the same SCS device, for 9 (+3) days a
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: *Subjects are male/ female, 18 years to 70 years *Chronic, persistent, refractory, unilateral neuropathic limb pain, as a result of spinal surgery *Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and minimally interventional pain procedures for chronic pain *Pain radiating in the leg, following segments L4 and/or L5 and/or S1 for at least 6 months *Minimum baseline pain intensity as assessed by VAS of * 50mm on 100mm scale in the primary pain area *Subject is able and willing to provide informed consent *Subject is able and willing to comply with the protocol and follow-up schedule *Subject has been included for implantation according to standard criteria from the Dutch Neuromodulation Society
Exclusion criteria
Exclusion criteria: *Back pain component of more than 20% or VAS > 40mm on 100mm scale *Bilateral limb pain *Subjects with a previous SCS implantation. *Changes in pain medication in the 2 months preceding the trial period; *Expected inability of subjects to correctly operate the neurostimulation system *Presence of any other clinically significant or disabling chronic pain condition e.g. hip arthrosis, rheumatoid arthritis, fibromyalgia, etc. *History of coagulation disorders, lupus erythematosus, diabetes mellitus, or morbus Bechterew *Symptoms or proof of any malignant disease *Current use of medicines affecting coagulation which cannot be temporarily stopped *Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator *Life expectancy of less than 1 year *Existing or planned pregnancy in the trial period *BMI 35 * a maximum and minimum BMI limit are imposed due to the technical difficulties and risk of complications in underweight or morbidly obese subjects. *Participation in another clinical study in the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to compare pain suppression in two groups of subjects with unilateral neuropathic limb pain, due to FBSS. Two parameter settings will be tested i.e. Low Frequency and High Frequency Spinal Cord Stimulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Energy use of the battery at different frequencies *Percentage of subjects with 50% reduction in pain according to the Dutch Neuromodulation Society criteria *Use of rescue medication in the trial and post-operative period *Number of amplitude adjustments in trial period *Discomfort due to stimulation *Improvement in disability *Subject satisfaction *Change in employment status *Change in sleep pattern *Monitoring of adverse events to both stimulation types | — |
Countries
Netherlands
Outcome results
None listed