Benefits in pain perception, ability function and health-related quality of life in patients with failed back surgery syndrome undergoing spinal cord stimulation in a clinical practice setting

Abstract

BackgroundFailed back surgery syndrome (FBSS) represents one main cause of chronic neuropathic or mixed pain, functional disability and reduced Health Related Quality of Life (HRQoL). Spinal Cord Stimulation (SCS) can be a value for money option to treat patients refractory to conventional medical management (CMM).We estimated from real-world data: 1) the amount of reduced levels of HRQoL of target patients compared to general population, 2) the relationship between pain intensity, functional disability, and overall HRQoL, and 3) the improvement of patients’ health from SCS intervention, and 4) we give some insights and make some suggestions on the selection of a battery of patients’ reported health instruments for use in routine clinical practice.MethodsAt recruitment (before SCS) and every 6 months for 2 years after SCS a battery of questionnaires/tests were completed: the generic EQ-5D and SF-36 for HRQoL, the specific Numerical Rating Scale (NRS) to measure pain intensity, and Oswestry Disability Index (ODI) to measure functional disability. We conducted multilevel regression analyses to investigate the association of HRQoL with the NRS and ODI indexes; multiple regression analyses to compare EQ-5D data with those of the general population adjusted for age, sex and education, and statistical tests to compare the changes of HRQoL, NRS and ODI estimates at baseline with those measured during the follow-up.ResultsEighty patients (40% male, mean age = 58 years) participated. HRQoL was significantly worse in the patients than in the corresponding general population. Pain, functional disability and HRQoL significantly related each other during follow-up, Significant improvements (p < 0.001) in pain intensity, functional capability and HRQoL were reached after 6 months from SCS and generally remained stable during follow-up. Specific instruments provided detailed information on disability and pain, while generic instruments assessed the overall HRQoL and allowed a comparison with the general population’s one.ConclusionsSCS + CMM treatment reaches a statistically significant and probably a clinically relevant improvement in pain perception, functional disability and HRQoL in patients with FBSS refractory to CMM. An appropriate selection of instruments for use in clinical practice is crucial for a routine assessment of health perception in patients, aimed to guide decisions for optimal treatment.

Spinal Cord Stimulation for Refractary Neuropathic Pain and Its Action on the Neurovegetative Systems

“…Importantly, the evolution of patients after SCS related to routine activities improved dramatically after the 3-month, and kept constant during all 12-month period evaluation. Although in the present study the improvement of functional capability was demonstrated after the 3-month, Scalone L et al (2018) described that pain, functional disability and Health Related Quality of Life significantly reached improvement after 6 months from SCS and generally remained stable during the 2-year follow-up [12]. In contrast, our population in this actual study demonstrated an improvement of pain after 1 month, improvement of functional disability after the 3-month.…”

The Added Value of High Dose Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome after Conversion from Standard Spinal Cord Stimulation

“…The EQ VAS of FBSS patients before salvation is 51.1 (±20.3) in this study. This is significantly higher than the novo SCS patients, as reported in the study of Scalone et al with an EQ VAS of 37.4 [ 32 ]. EQ VAS comparison between our baseline results (51.1(±20.3)) and the results of Scalone et al at 12 months of SCS (55) only indicates a small difference although patient satisfaction with SCS was highly incomparable.…”

“…FBSS patients, prior to SCS implantation, report pain and limited capabilities as the greatest impairments of their quality of life. In a recent study by Scalone et al, 65% of FBSS patients reported on the EQ5D-3L extreme problems on the subdomain of “pain”, whereas 41.3% reported extreme problems on the subdomain of “usual activities” [ 32 ].…”

Real‐World Analysis: Long‐Term Effect of Spinal Cord Stimulation With Different Waveforms for Patients With Failed Back Surgery Syndrome

“…In a comparative study between SCS and repeat surgery, the effect of SCS was superior to surgery for the alleviation of nerve root compression 3 . After the compelling randomized controlled study of North et al, 3 several studies confirmed the reduction of pain scores with SCS 1,4–6 …”

“…Chronic pain caused by failed back surgery syndrome (FBSS) is associated with a higher pain score, lower health‐related quality of life (HRQoL), and higher functional disability when compared with the general population 1 . Compared to patients suffering from other chronic pain (eg, complex regional pain syndrome, rheumatoid arthritis, osteoarthritis, and fibromyalgia), patients with FBSS have higher pain scores and a lower HRQoL 2 …”