The patients included in this study have already undergone the process of probe implantation and adjustment to their individually suitable stimulation pattern. Patients will be selected if the probe was implanted 0 - 5 years ago. Patients with implanted percutaneous electrodes (octrodes) and plate electrodes (surgical lead group) will be included in the study. The aim of this study is to investigate whether additional muscle stimulation can optimize the current pain therapy. After being informed about the study and providing informed consent, the questionnaires (baseline) are completed before the start of the study. Then, in addition to the existing BurstDR stimulation, additional muscle stimulation is started twice a day for 30 minutes and continued for 3 months. During this time, the pain values are also determined every 4 weeks using the visual analog scale (VAS), Oswestry Disabillity Index (ODI), EQ5D-5L, Pain Catastrophizing Scale (PCS), Pain Disability Index (PDI), Patient Global Impression of Change (PGIC). At the end of 3 months, the questionnaires are completed again. The VAS values and the values from the questionnaires are compared with the baseline values. In addition, possible side effects and adverse reactions that could be triggered by the stimulation are recorded at this time. This study makes it possible to investigate the combination of pain treatment with BurstDR and simultaneous muscle stimulation with an Octrodes and pentaleads for chronic back pain in a prospective study.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
visual Analogue SCALE (VAS)
Timeframe: 4 weeks, 8 weeks and 12 weeks