MSCS in BURSTDR Patients

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.

Basics of SCS Spinal cord stimulation (SCS) was developed at the end of 1960 for the treatment of chronic, untreatable pain and has since been used to treat various pain syndromes (PSPS, CRPS, ischemic pain, phantom pain, etc.). The pathophysiological basis for the development of SCS was the gate control theory, which states that stimulation of the mechanosensitive Aβ fibers suppresses the transmission of pain stimuli via the pain-sensitive C fibers to the brain in the spinal cord. Conventional SCS consists of regularly emitted tonic pulses with a frequency between 30 and 120 Hz. During implantation, the electrodes are placed in the epidural space in such a way that the paresthesia caused by the nerve stimulation covers the painful area (dermatome) and thus relieves the pain. The frequency, amplitude and pulse width can be varied to maximize pain relief. Kuechmann et al were able to show that many patients experience unpleasant stimulation when changing position and therefore have to adapt the stimulation program accordingly. BurstDRTM-Stimulation In 2010, De Ridder et al. published the first study on a new stimulation method for SCS - BurstDR stimulation. Here, bursts of high-frequency pulses are delivered at certain intervals (bursts at a frequency of 40 Hz with 5 pulse peaks of 500 Hz per burst). According to current knowledge, this mode of signal transmission also exists in human neurons in the thalamus. Based on animal studies, it is assumed that these burst volleys have a greater effect on the cortex in the sense of a wake-up call. BurstDR has been the subject of numerous studies comparing its effectiveness with conventional SCS. A significant difference is the absence of paraesthesia in most cases and the more effective pain relief in some cases. In addition, BurstDR stimulation is thought to modulate the medial pain pathway, which can result in a change in the emotional and attention-related assessment of pain. The problem of chronic back pain Chronic back pain is difficult to treat adequately. Physiotherapy and therapeutic exercises are usually the first treatment methods used. Medication is also administered. If there is no improvement, many patients are advised to undergo surgery on the lumbar spine. The results here are generally good. However, there is a not inconsiderable percentage (5-25%) who do not benefit from surgery or even repeated operations. These patients usually receive pain therapy. If there is no improvement here either, there is the option of a neuromodulatory procedure to relieve the pain. The most common procedure currently used for back pain is spinal cord stimulation (SCS). However, there are problems with the use of SCS that repeatedly impair the results of this treatment for chronic back pain. Problems of treating chronic back pain with SCS stimulation The first problem is the large number of different types of tissue in the back, all of which can cause pain: Bones (e.g. collapsed vertebral bodies), joints (f trial.show_full_description

Inclusion Criteria: * Patients with PSPS type 2 * Patients with predominant back pain * Patients with SCS(BurstDR) stimulation in situ with \>50% pain relief. Patients have to be satisfied with their existing SCS therapy and predominantly use a BurstDR stimulation program. ) (Only responders to that therapy should be included, not patients who have not responded to their therapy so far.) * Patient must be willing and able to provide written informed consent before any clinical investigation-related procedure * Age ≥18 y * Low back pain baseline score of ≥6 on NRS before spinal cord stimulation therapy and a MCID (Minimal clinically important difference) of \>30% with SCS(BurstDR) stimulation. * Willing and able to comply with the instructions for use, operate the study device, and comply with this clinical investigation plan Exclusion Criteria: * Pathology seen on imaging tests that is clearly identified and is likely the cause of the CLBP, that can be addressed with surgery, or related to these origins: * vascular causes (eg, aortic aneurysm) * spinal infection (eg, osteomyelitis) * inflammation or damage to the spinal cord (eg, arachnoiditis or syringomyelia) * tumor or spinal metastases * Severe scoliotic deformity (\>11◦ in thoracic or lumbar spine) * Primary symptom of leg pain, or leg pain is greater than back pain * Has widespread pain (eg, fibromyalgia) or pain in other area(s), not intended to be treated in this study (eg, neck pain, shoulder pain) * Patient has used a morphine equivalent daily dose of \>50 MME in the last 30 d * Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma) * Known allergic reaction to implanted materials * Patient has a history of or existing intrathecal drug pump * Patient has previous experience with neuromodulation devices, including a failed trial * BMI \>40 * Patient is enrolled, or intends to participate, in another clinical drug and/or device study or registry that may interfere with the results of this study. * Presence of other anatomic or comorbid conditions, or other medical, social, or psychologic conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results * Failed psychologic evaluation * Suspicion or evidence of untreated mental illness, substance abuse, or drug-seeking behavior * Patient is in current litigation for back pain/injury, or is currently receiving worker's compensation * Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.