A feasibility study regarding physical activity in Spinal Cord Stimulation for patients with Failed Back Surgery Syndrome

Patients who suffer from Failed Back Surgery Syndrome (FBSS) experience chronic pain in the low back region and/or lower extremity, often resulting in diminished physical activity. It is known that FBSS affects all domains of life, although these impairments remain difficult to quantify even when they receive Spinal Cord Stimulation (SCS).
Currently, the evaluation of the clinical outcomes of SCS therapy in patients with FBSS is mostly done by standardized pain and quality of life measurements instruments, which hardly account for personal feelings and needs regarding physical activity.
The Intellis AdaptiveStim™ SCS system has an accelerometer to collect objective data of the body positions, while a smartwatch gives objective data of the bodily functions.
To use both tools, we aim to get new insights into the physical activity of FBSS patients before and after the implantation of the SCS.

We hypothesize that collecting objective data from 1) the AdaptiveStim™ SCS system and 2) a smartwatch contribute to evaluating the physical activity of FBSS patients. We also hypothesize that qualitative semi-structured interviews based on the six dimensions of the Positive Health model of Huber et al. contribute to the evaluation of patients experiences, objectives and future aims regarding SCS therapy of FBSS patients.

T= -21 days before SCS implant
T= end trial period
T= 3 month FU

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), EuroQol 5D (EQ-5D), Medical Outcome Study-Short Form-36 (MOS- SF 36), Mc Gill Pain Questionnaire, Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), Oswestry) + medication list
- Diagram of Positive Health and perform a face to face in-depth interview

T= end of trial period. Collecting data:
- Smartwatch
- VAS and medication list.
- Diagram of Positive Health

T= 0 implant Intellis AdaptiveStim™ in the left buttock at the same location where the unsterile battery was located.

T= FU 3 month SCS: Collecting data:
- Intellis AdaptiveStim™ + smartwatch
- Self-supporting questionnaires (Visual Analogue Scale (VAS), EuroQol 5D (EQ-5D), Medical Outcome Study-Short Form-36 (MOS- SF 36), McGill Pain
Questionnaire, Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), Oswestry + medication list
- Diagram of Positive Health and perform a face to face in-depth interview
- Evaluation form for patients and clinicians