M54.4
Conditions
Interventions
Group 1: SCS device with SCS paradigm "burst"
Group 2: SCS device with SCS paradigm 1 kHz
Group 3: SCS device with SCS paradigm 1.499 kHz
Group 4: SCS device with SCS paradigm placebo-stimulation
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients suffering from intractable neuropathic pain, who have been considered for SCS therapy according to current German treatment guidelines and, within 48 of study enrolment, were already implanted with a wireless SCS device (Stimwave®) • Placement of the distal tip of the electrode between upper level of Th8 and lower level of Th12 • leg pain > back pain • age of patient = 18 Jahre • Written consent • Duration of pain history >6 months and < 5 years
Exclusion criteria
Exclusion criteria: • Covering of the pain area with the SCS stimulation device (Stimwave®) <90% • Ischemic pain (i.e. Peripheral artery disease, angioma) • Chronic primary pain • Implantation of several SCS electrodes • Coagulopathy • Any planned changes in existing pain medication for the duration of trial participation (period of 35 days) • Pregnancy • Neurodegenerative disease • Lack of understanding of the trial and the individual consequences of participating in the trial • Expected lack of compliance (i.e. patient is not able to complete the trial questionnaires)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-assessment of pain perception measured on the Visual Analogue Scale (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-assessment of pain quality (as determined by Pain Detect Questionnaire), quality of life (as determined by Quality of Life EQ-5D-5L Questionnaire), anxiety perception (as determined by the Hospital Anxiety and Depression Scale) and physical restriction (as determined by the Oswestry Disability Index) | — |
Countries
Germany
Contacts
Public ContactRezvan Ahmadi
Neurochirurgische UniversitätsklinikUniversitätsklinikum Heidelberg
Outcome results
None listed