Is the Self-Reporting of Failed Back Surgery Syndrome Patients Treated With Spinal Cord Stimulation in Line With Objective Measurements? (original) (raw)
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Health and quality of life outcomes, 2018
Failed 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. At 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 Disabil...
The Egyptian Journal of Neurology, Psychiatry and Neurosurgery
Background Failed back surgery syndrome (FBSS) is a common problem affecting 20–40% of cases undergoing spine surgeries. Spinal cord stimulation (SCS) has been shown to be an efficient and relatively safe treatment in managing many intractable chronic pain syndromes. Objectives This study compares the efficacy and safety of MR-compatible sensor driven-position adaptive SCS and conventional SCS in treating FBSS. Methods This is a retrospective case series of 120 consecutive FBSS patients who underwent SCS between February 2011 and March 2018. Pain levels, analgesic/opioid use, and sleep problems were assessed before and 3 months after the procedure in patients who received either conventional SCS (group 1; n = 62) or sensor-driven position adaptive SCS (group 2; n = 34). The degree of patient satisfaction, the change in the activities of daily living (ADLs) together with the rate of complications were compared in both treatment groups. Results The two treatment groups were homogenous...
Pain Medicine, 2017
Objectives. Spinal cord stimulation (SCS) for patients with failed back surgery syndrome (FBSS) show variable results and limited to moderate evidence. In the last years the stimulation of high frequency (HF) has been considered as a better alternative in this pathology for its supposed benefits compared to the stimulation with conventional frequency (CF). To compare in one year follow-up, the efficacy of high-frequency SCS (HF) versus conventional frequency SCS (CF) on the patients with FBSS. Design. Prospective, Randomized blind trial. Setting. Academic University Pain Medicine Center. Subject. Seventy eight patients with FBSS diagnosis based on internationally recognized criteria, and refractory to conservative therapy for at least 6 months, have been initially recruited, and Methods. Sixty subjects met the eligibility criteria and were randomized and scheduled for the trial phase.The patients were randomly assigned in either, one of the two groups: CF SCS or HF SCS. Within the study methods, special attention was paid to standardizing patient programming, so that these parameters would not impact the results.The trial period was considered successful if there was ? 50% reduction in the NRS from baseline. Results. A total of 55 subjects successfully completed all assessments during one year follow-up. Change patterns in scores do not differ based on high versus conventional frequency, with significant global average reduction at 1year similarly for both groups. Among all the items included in the Short Form-12 questionnaire (SF-12), only the variations in the social function score between the instants t1 and t2 are somewhat higher in the high frequency group. Conclusion. The evolutionary pattern of the different parameters studied in our patients with FBSS does not differ according to their treatment by spinal stimulation, with conventional or high frequency, in one year follow-up.
European Journal of Pain, 2012
The aim of this review was to determine the impact of spinal cord stimulation (SCS) on physical function and sleep quality in individuals with failed back surgery syndrome (FBSS). This review comprised three phases: an electronic database search (PubMed, Cinahl Plus, EMBASE, PsychInfo, Pedro, Cochrane Library) identified potential papers; these were screened for inclusion criteria, with extraction of data from accepted papers and rating of internal validity by two independent reviewers using the Effective Public Health Practice Project quality assessment tool, a tool designed to assess non-RCTs (randomized controlled trials) as well as RCTs. Strength of the evidence was rated using the Agency for Health Care Policy and Research guidelines. The search generated 13 quantitative papers that fulfilled the inclusion criteria; all 13 studies investigated the impact of SCS on physical function, and nine studies investigated the impact of SCS on sleep quality. Consistent evidence (level C) found that SCS positively affected physical function, with improvements in participation in activities of daily living, leisure, social and work-related activities. Similarly, consistent evidence (level C) found improvements in sleep quality following SCS. Improvements in sleep quantity, a reduction in awakenings and a decrease in sleep medication use were also noted (level D). The impact of SCS on cognitive function, i.e., memory and concentration, was also assessed using the same search strategy, no papers fulfilled the inclusion criteria for this study. Spinal cord stimulation effectively addressed many physical function and sleep problems associated with FBSS; however, there is a need for further high-quality objective investigations to support this.
Psychological Variables Associated With Outcome of Spinal Cord Stimulation Trials
Neuromodulation: Technology at the Neural Interface, 1998
Study Design. Thi s is a prospective study designed to identify psychological factors associated with response to spinal cord stimulation (SCS) trial. Summury of Background Data. In most centers, implantation of a permanent SCS system is preceded by a trial of a temporary stimulating electrode. Yet, even among those who report greater than 50% pain reduction during trial. a significant number of these patients fall to receive long-term pain relief from the permanent system. Because mood disorders can alter pain report, we hypothesized that refined definition of the psychological factors associated with SCS success could result in improved selection of candidates for SCS trial. Methods-The study sample consisted of 43 chronic pain patients (72% failed back surgery syndrome, 77% with radiating low back pain) who were referred for implantable pain management. Following psychological evaluation, patients were admitted for a three-day inpatient trial of SCS. Report of at least 50% pain relief during trial was considered a success and resulted in implantation of the permanent stimulator, Patients were retrospectively divided into two groups: those whose pretrial pain was relieved by at least 50% ("success") and those whose paln was relieved by l ess than 50% ("failure"). Resuns. Univariate t-test or chi-square analyzes of group means of an extensive psychological battery followed Reprint requests to Kern A. Olson. Ph.D.. Paln Management Center, Ore
Neuromodulation: Technology at …, 2007
Background. Spinal cord stimulation (SCS) is effective in reducing pain from a number of differing medical conditions that are refractory to other, more conservative treatments. Much is written in the literature regarding efficacy and safety of SCS; however, no one to our knowledge has compared and reported safety and efficacy of SCS when using differing manufactured SCS devices. We undertook such a preliminary evaluation. Methods. Charts from the years 2001-2005 of our clinic's patients who had undergone trials and placement of permanent SCS systems were selected for review. All patients who had received either an Advanced Bionics SCS system (Advanced Bionics, Valencia, CA, USA), an Advanced Neuromodulation Systems (ANS) SCS system (ANS, Plano, TX, USA), or a Medtronic SCS system (Medtronic, Inc., Minneapolis, MN, USA) were given a survey to complete for data analysis. Patients were categorized into three groups: those patients having received a Medtronic (Mdt) SCS system, those patients having received an Advance Bionics (ABi) SCS system, and those patients having received an Advance Neuromodulation Systems (ANS) SCS system. Data, limited to volunteers, who gave their written consent, were analyzed for efficacy and complications. Differences in outcomes and safety were analyzed overall and according to manufacturer. Results. Eighty surveys were mailed out to 80 patients and 30 surveys were completed and returned, a return and completion rate of 37.5%. All patients showed improvement in all aspects including pain relief, sleep, functional activities, and medication use for pain control. When comparing outcomes of SCS from the three different companies, there was no significant statistical difference in average percentage pain relief, sleep improvement, and medication needed for pain control. However, there was a statistically different less change in functional improvement in the ABi group when compared to patients in the Mdt and ANS groups. Conclusions. Spinal cord stimulation improves pain, sleep, and function in patients with intractable pain. Because of the low number of patients evaluable in this study, we believe that conclusions should not be made regarding the effect of technology on outcomes or safety. We believe that an analysis of this type in larger populations is warranted to understand the role, if any, that present-day technology has on outcomes of SCS.
Neurosurgery, 1997
Departm ents of Neurosurgery (RBN , D H K , RLW) and C lin ic a l Psychology (DE), The Johns H o p kin s U niversity School of M edicine, Baltimore, M aryland OBJECTIVE: Associations between psychological and physical states are understood to exist, and the development of standardized psychological tests has allowed quantitative evaluation of this relationship. We tested whether associations exist between psychological test instruments and patients selected for therapeutic trials of spinal cord stimulation (SCS) for chronic, intractable pain. METHODS: Fifty-eight patients selected for SCS were tested prospectively with a battery of standardized psycho logical tests: Minnesota Multiphasic Personality Inventory with Wiggins content scales, Symptom Check List-90, and Derogatis Affects Balance Scale. Associations between treatment outcomes and preoperative test scores and clinical variables were tested by univariate and multivariate statistical analyses, in which the dependent variables were as follows: 1) the outcome of a therapeutic trial of stimulation (whether the patient derived sufficient reported pain relief with a temporary electrode to proceed with a permanent implant), and 2) long-term outcome of treatment with the permanent implant, as determined by disinterested third-party interview. RESULTS: Significant associations (P < 0.01) were observed between the outcome of the therapeutic trial of stimulation and psychological test results; patients with low "anxiety" scores on the Derogatis Affects Balance Scale and with high "organic symptoms" scores on the Wiggins test were significantly more likely to proceed to permanent implants, as determined by multivariate statistical models. There was an elevation in the Minnesota Multiphasic Personality Inventory hypochondriasis scale in these patients by univariate (P = 0.02), but not by multivariate, models. The multivariate model also identified young age, reproduction of leg pain by straight leg raising, and bilateral leg pain as favorable prognostic factors. The only association with favorable long-term outcome of implantation of a permanent device, by univariate analysis, was an elevated "joy" score on the Derogatis Affects Balance Scale. Multivariate analysis revealed no statistically significant predictors of long-term outcome. CO N CLU SIO N : Because our study population was selected on the basis of recognized prognostic factors and long clinical experience, it may not be possible to generalize our findings to the overall pain clinic referral population. In the subpopulation we have chosen for SCS trials, psychological testing is of modest value and explains little of the observed variance in outcome. We find little evidence for selecting patients for SCS on the basis of psychological testing. Because self-reported outcome measures may themselves reflect the patient's psychological state, these findings should be considered carefully, in overall clinical context. A prospective study with additional objective outcome measures is underway, which will address some of these issues. (N eu rosu rg ery 3 9 : 3 0 1-3 1 1 , 1 9 9 6) Key w o rd s : C h r o n ic p a in , E le c tr ic a l s tim u la tio n , P s y c h o lo g ic a l te s tin g , S p in a l c o r d s tim u la tio n S election of patients for spinal cord stim ulator im planta-ion ultim ately will fail treatm ent. A nu m ber of additional, tion for the m anagem en t of chronic, intractable pain potential prognostic factors have been reported; these have routinely involves a therapeutic trial with a tem porary included technical aspects of treatm ent and patient characterpercutaneous electrode. A lthough this em ulates long-term istics, both physical and psychological (7, 25, 43, 47, 48). therapy closely, it pred icts long-term results im perfectly; be-Physicians have long observed associations betw een psytween one-third and on e-h alf of patients selected in this fash-chological and physical states. The d evelopm en t of sensitive,