Investigation of efficacy of different spinal cord stimulation paradigms for the treatment of chronic neuropathic pai

Not Applicable

Recruiting

Conditions: M54.4
Lumbago with sciatica

Registration Number: DRKS00018929

Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

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

• 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)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-assessment of pain perception measured on the Visual Analogue Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
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)