chronische neuropathische pijn als gevolg van Failed Back Surgery Syndrome Low Back Pain after low back sugery
Conditions
Interventions
Patients will receive a standard SCS treatment targeting to relief leg and back
pain. The study group consists of patients having a pain reduction of >=50% in
the leg but less than 50% back pain rel
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male/female >= 18 and = 5 scored separately for leg and back . Insufficient pain reduction after medication, invasive pain therapy, TENS, etc. • Willing to provide informed consent
Exclusion criteria
Exclusion criteria: • Presence of any other clinically significant or disabling chronic pain condition • Expected inability of patients to properly operate the neurostimulation system • History of coagulation disorders, lupus erythematosus, diabetes mellitus, rheumatoid arthritis or morbus Bechterew • Active malignancy • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with SCS plus SubQ and SCS alone having 50% or more pain relief (responder rate) in back after 3 months of stimulation, assessed with the VAS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of SCS plus SubQ or SCS alone after 3, 6 and 12 months on: • Mean reduction in pain intensity for leg and back pain separately, assessed by the VAS • Responder rate of SCS on leg pain assessed by the VAS • Responder rate of SubQ on back pain assessed by the VAS (after 6 and 12 months) • Quality of life assessed by Short Form 36 (SF-36) • Quality of life as assessed by EuroQuol (EQ-5D) • Function assessed by the Oswestry disability index • Patient satisfaction assessed by the Global Impression of Change (GPIC) • Pain assessed by the McGill questionnaire • Concomitant drug treatment for relief of pain • Concomitant need for physical therapy or other non-drug treatment. • Employment status • Frequency and nature of adverse events And in addition after 12 months of stimulation, on: • Cost-utility • Preferred stimulation settings | — |
Countries
Netherlands
Outcome results
None listed