Naturepulse™ (previously PBK) Therapy in Failed Back Surgery Syndrome (FBSS): a case report.

Introduction

Failed back surgery syndrome, (FBSS), is a secondary, persistent or recurrent chronic pain to one or more surgical procedures to the lumbosacral spine. Commonly one refers to it as FBSS like a persistent fixed pain, frequently localized to the lower limbs, sciatica, caused by an insufficient functioning of the spine (1). The phenomenon manifests itself in varying cases, including between 10% and 50% of surgical procedures for hernia of the disc (2). The first and main cause of the surgical failure is the inadequate pre-surgical attention of the patient, therefore the lack of suitable preoperative planning. The second cause of the syndrome is the result of anatomic-surgical factors around the area of the lumbosacral region. The most common of the etiopathogenic mechanisms that influence bad prognosis is the entrapment of the nervous system and eventual intertwining of the fibrous post-surgical scars with the nerves. These alterations develop into a condition of nervous ischaemia, and successive occurrences of neurite and severe radicular (3) pain. The neuro inflammatory origin of the process, however, imposes a strict appraisal of the patient with FBSS. In patients with persistent and painful symptoms, it would be better to first assess the surgical outcomes and to consider if the new condition, can be, unequivocally, related to the previous surgery, to a new problem of the vertebrae, or to a new painful idiopathic syndrome. FBSS can in effect be seen with a certain type of heterogeneity in clinical tests. It can be secondary to a recidivism of the hernia of the disc in the same area or in another area, to a fibrous epidural type, an arachnoiditis, a syndrome of the articular facets, to a spinal iatrogenic stenosis, to instability spondylitis or spondylodiscitis (4).

Clinical history

A 53-year-old woman came to our attention with recurring lumbosacral pain, from obvious spinal origin, that radiated from the spine to the inferior limbs, mostly to the one on the right. The patient reported having had a discectomy, approximately two years before the present algological visit was performed. She was under a rehabilitation programme for a year post operatively, because she had serious functional restriction in moving and deambulation. The secondary consequence of these serious painful symptoms, on the lumbosacral spine and the lower limbs, severely limited autonomy, quality of life and emotional well being of the patient. The pain was not relieved with “conventional” analgesic treatments. The level of pain intensity was equal to a VAS score of 7, at rest, in the visual analogical scale, from 0=no pain to 10= insupportable pain. Characteristically the pain was chronic, continuous, dormant, dull, burdening but with acute episodes which correlated to physical activity. In relation to deambulation, as an example, the VAS score was 10. The pain symptomatology was accompanied by burning sensation, tingling, and paraesthesia to the lower limbs and hyposthenia. The unbiased neurological examination discovered: rigidity of the lumbosacral spine, with pain encouraged by the digitopression of the spinal cord, spasms of the paravertebral muscles, loss of the physiological curvature of the spine, weakness of the bending of the plantar, loss of the reflex to the right Achilles heal, Carpal Tunnel in areas L5-S1, bilaterally. Deambulation was autonomous, but the postural transition from lying down, to sitting, to standing position, became difficult due to strong pain. Also observed was a neurogenic movement due to stenosis of the spinal cord. The patient undertook a recent MRI, undertaken approximately one month before the algological visit. The MRI reported the post-operative pathological modifications which were right partial laminectomies, anomalies of paraspinal soft-tissue in the posterior region, mass of soft-tissue to the level of epidural, thought probably to be scar tissue, since it turned out to be hypointense in the sequences T1-weighed and hyperintense in the images T2-weighed, if compared to the muscular tissue in the area L5-S1. Other similar tissue, of a fibrous nature, was visible previously and was qualified as a relapsed hernia, fibrous perineural tissues, connection between the nervous system or expanded radicular girdles of the nervous system.

Treatment

The conservative treatment via analgesics in patients with FBSS is currently difficult and a possible challenge with methodologies and drugs at the disposal of doctors. The therapeutic approach must be multidisciplinary and aimed at the interruption of the mechanisms responsible for the chronic pain. In this light opioid was prescribed to the patient, Tramadol, 100mg every eight hours, in slow release tablets, an antiepileptic, Gabapentina, in doses up to 2400 mg/day, a tricyclic antidepressant, 10mg in the evening.

After being informed and with prior agreement, we suggested to the patient to undergo two complete treatments Naturepulse™ (PBK-2C) the following month, including 20 sessions of approximately 20 minutes each, 5 days a week, administered in a clinic. The therapy was made up of 3 components to stimulate, performed in sequence and named "decontracting", "antiphlogistic", "microcircle". The positive surface electrodes (red) were positioned at the level of the metamerism corresponding to the painful root, L5-S1, while the negative ones (black) were placed about 10-15 cm away, to enclose an area of at least equal to the area in pain on the surface. The patient was required to indicate to the examiner the threshold level of stimulation, when the feeling of the paresthesia surface was pleasant and relaxing. Where it was felt a reduction in the intensity of the impulse, after a few minutes at the beginning of the procedure, we increased the level of stimulation, until the patient stated that she had reached the previous level of feeling. In addition, two samples were taken of blood to determine the serum for the VEGF, at the beginning and end of the cycle of application (T0-T1) of the Naturepulse™ . A sample of venous blood was taken from a peripheral access. The samples were immediately centrifuged in the laboratory for 10 min at 3000 rpm. The supernatant liquid was stored in a refrigerator at - 40 ° C. The level of serum VEGF was determined by an ELISA test, widely commercially available (R & D Systems, Wiesbaden, Germany). The test is calibrated with VEGF165, human recombinant, highly purified, the largest and most active isoform of the VEGF. The test is able to detect VEGF free, unbound, with a rate of accuracy and sensitivity that approaches 100% in serum.

Outcome

The patient was carefully observed for the whole period of treatment, 30 days, recording in the case folder the change in VAS score (T0-T1). It was considered a therapeutic success and a reliable decrease in this parameter at least by 50% at follow-up. We recorded in the case folder the final base serum values (T0-T1) of the VEGF, according to the method reported above. We used a 5 point scale, from the first visit, evaluating the muscular strength and the range of movement (ROM), to recommend again at the end of the therapeutic sessions electroanalgesis (T0-T1). We questioned further the patient about the main factors affecting the quality of life, repeating the detailed analysis at T0 and T1. These were the quality of sleep in terms of hours of sleep at night, the level of mood, assessing qualitatively between zero = bad, a = low, medium = two, three = sufficient, four = Good and five= excellent, the grade of satisfaction relative to the treatment. All the functional levels observed had significant improvement, in 1 month.

Conclusions

The clinical case reported above shows an effective and safe new treatment method, Naturepulse™, allowing us to achieve positive results, analgesia and functional rehabilitation in difficult cases known as failed back surgery syndrome (FBSS).