Patients suffering FBSS with low back pain and/ or leg pain
Conditions
Interventions
T= -21 days before the implant of the SCS. Collecting data:
- Unsterile Intellis AdaptiveStim™ placed on the left buttock + smartwatch
- Self-supporting questionnaires (Visual Analogue Scale (VAS), Eu
Sponsors
Radboudumc, Nijmegen, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: - Age between 18 and 75 years - Diagnosed with a Failed Back Surgery Syndrome with low back pain and leg pain. Pain radiating in lumbar segments L4, L5 and S1 - Experienced chronic pain for = six months with a pain score = 5 for the weighted Visual Analogue Scale (VAS) - No option for further surgical intervention - Previous pain treatments have been unsuccessful (insufficient pain relief or unacceptable side effects) - Psychological screened- - Willing to provide informed consent
Exclusion criteria
Exclusion criteria: - Presence of any other clinically significant or disabling chronic pain condition - The expected inability of the patients to properly operate the neurostimulation system - An SCS procedure in the history - Addiction to drugs, alcohol (= 5 E / day) or medication - Insufficient cooperation (little motivation, understanding) - History of coagulation disorders, lupus erythematosus, diabetes mellitus, rheumatoid arthritis or Morbus Bechterew - Current use of medication affecting coagulation which cannot be temporarily stopped - Unable to speak or understand the Dutch language - Life expectancy < 1 year - Pacemaker - Local infection or other skin problems in the operation area - Existing or planned pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - The feasibility of collecting objective data of the AdaptiveStim™, externally located on the left buttock and internally placed in the left buttock, measured physical activity in different body positions. - The feasibility of collecting objective data of the smartwatch measured physical activities and bodily functions before and after SCS implant. - Overview of the self-supporting questionnaires before and after SCS implant. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Overview of the diagram of Positive Health before and after SCS implant. - Codes and themes derived from face to face in-depth interviews guided by the diagram of Positive Health by Huber et al. - Overview of the evaluation forms from patients and clinicians | — |
Contacts
Public ContactTanja Hamm-Faber
Albert Schweitzer Hospital, Department of Pain Medicine
Outcome results
None listed