Papers by Francisco Kovacs
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Nonspecific low back pain is a very common disorder for which no completely satisfactory treatmen... more Nonspecific low back pain is a very common disorder for which no completely satisfactory treatment has been established. A randomized, double-blind, controlled clinical trial was design to assess the efficacy of neuro-reflexotherapic intervention in the treatment of this condition. Ninety-one patients with a confirmed diagnosis of nonspecific low back pain were referred for treatment from primary health care facilities in the Spanish National Health System. A total of 43 patients were assigned to the control group and 48 to the treatment group. Patients in the treatment group received a single neuro-reflexotherapic intervention. Patients in the control group underwent a similar procedure, although inappropriate zones were stimulated. Patients in both groups were allowed to continue drug and physiotherapy treatments prescribed by their general practitioners. According to the design the study was ended when statistically significant and clinically evaluable results were obtained in an analysis carried out half way through the study. Participants underwent clinical evaluations on three occasions: immediately prior to intervention, immediately after and on day 30 afterwards. Patients in the treatment group showed immediate clinically and statistically significant improvements (p < 0.0001) in pain, muscular contracture and mobility, allowing them to discontinue pharmacological treatment and keeping them free of symptoms during the study period. According to results of this study, neuro-reflexotherapic intervention has proved to be an effective method for treating low back pain.
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Correlation between variables measured with previously validated instruments. To explore the asso... more Correlation between variables measured with previously validated instruments. To explore the association between catastrophizing and disability in patients treated for subacute or chronic low back pain (LBP) within routine clinical practice in Spain. The influence of psychological variables on LBP-related disability in Southern Europe is different to the one in the Anglo-Saxon and Northern European cultural environments. In Spanish LBP patients, the influence of fear avoidance beliefs on disability is negligible, and catastrophizing does not mediate the improvement of disability caused by active education. The association between catastrophizing and dis-ability is unknown. Thirty-three clinicians working for the Spanish National Health Service in 6 primary care and 8 specialty centers, recruited 1461 patients seeking care for subacute and chronic LBP. Patients were assessed only once. A linear regression model was developed to assess the percentage of the variance of disability explained by gender, age, chronicity status, severity of LBP, severity of referred pain (referred pain down to the leg), catastrophizing, eligible for workers' compensation (yes/no), failed back surgery (yes/no), radiologic findings, and treatments. Correlations among LBP, referred pain down to the leg, disability, and catastrophizing were moderate, but significant. The strongest one was between disability and catastrophizing (r ∇ 0.520). Catastrophizing explained 28% of disability, whereas severity of LBP only 3%. Global adjusted R of the model was 0.387. There was an association between some radiologic findings and treatments, and slightly higher levels of disability. In Southern European subacute and chronic LBP patients, catastrophizing correlates with dis-ability and explains approximately one-fourth of its variance. Further studies should assess its value as a prognostic factor in subacute and chronic patients.
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Spine Journal, 2012
The Spanish National Health Service (SNHS) is a tax-funded public organization that provides free... more The Spanish National Health Service (SNHS) is a tax-funded public organization that provides free health care to every resident in Spain. To develop models for predicting the evolution of low back pain (LBP) in routine clinical practice within SNHS. Analysis of a prospective registry in routine clinical practice, in 17 centers across SNHS. Patient sample includes 4,477 acute and chronic LBP patients treated in primary and hospital care. Pain and disability, measured through validated instruments. Patients treated for LBP were assessed at baseline and 3 months later. Data gathered were the following: sex, age, employment status, duration of pain, severity of LBP, pain down to the leg (LP) and disability, history of lumbar surgery, diagnostic procedures undertaken, imaging findings, and treatments used throughout the study period. Three separate multivariate logistic regression models were developed for predicting a clinically relevant improvement in LBP, LP, and disability at 3 months. In total, 4,261 patients (95.2%) attended follow-up. For all the models, calibration was reasonable and the area under the receiver operating characteristic curve was ≥0.640. For LBP, LP, and disability, factors associated with a higher probability of improvement at 3 months were the following: not having undergone lumbar surgery, higher baseline scores for the corresponding variable, lower ones for the rest, and being treated with neuroreflexotherapy. Additional factors were the following: for LBP, shorter pain duration; for LP, not undergoing electromyography; and for disability, shorter pain duration, not being diagnosed with disc degeneration, and being treated with muscle relaxants and not opioids. A prospective registry can be used for developing predictive models to quantify the odds that a given LBP patient will experience a clinically relevant improvement. This may empower patients for an informed shared decision making.
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International Journal of Technology Assessment in Health Care, 2014
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Revista Espanola De Salud Publica, 2008
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Spine, 2002
A cluster randomized, controlled trial was performed. To assess the clinical effectiveness and co... more A cluster randomized, controlled trial was performed. To assess the clinical effectiveness and cost-effectiveness of adding patients' referral to neuroreflexotherapy intervention to the usual management of subacute and chronic low back pain in routine general practice. Neuroreflexotherapy consists of the temporary implantation of epidermal devices in trigger points in the back and referred tender points in the ear. The efficacy of this procedure for treating subacute and chronic low back pain has been demonstrated in previous randomized, double-blind, controlled clinical trials. Twenty-one primary care physicians working in seven primary care centers of the Spanish National Health Service in Palma de Mallorca, Spain, were randomly assigned to the intervention group (n = 11) or the control group (n = 10). The physicians recruited patients who had low back pain that had lasted for 14 or more days despite drug treatment and who did not meet criteria for surgery. The 45 patients recruited by physicians from the control group were treated according to the standard protocol, whereas the 59 patients recruited by physicians from the intervention group were, in addition, referred to neuroreflexotherapy intervention. The analysis of variables was performed taking into account that physicians, not patients, were randomly assigned. Patients underwent clinical evaluations at baseline and 15, 60, and 365 days later. At baseline, median intensity of pain was higher in patients undergoing neuroreflexotherapy than in control patients (visual analogue scale, 6.07; range, 4.67-8.80 vs. 5.15, range 4.11-8.00) and median duration of pain was also higher (48.1, range 28.4-211.1 vs. 17.5, range 15.0-91.5 days). At the last follow-up visit, patients treated with neuroreflexotherapy showed greater improvement than did control patients in low back pain (visual analogue scale, 5.5; range, 3.7-8.8 vs. 1.9; range, -1.2-3.0; P < 0.001); referred pain (visual analogue scale, 3.6; range, 2.7-7.3 vs. 0.6; range, -1.5-2.0; P = 0.001); and disability (Roland-Morris scale, 8.7; range, 2.0-13.3 vs. 2.0; range, -1.5-6.7; P = 0.007). Moreover, neuroreflexotherapy intervention was associated with a significantly (P < 0.035) lower number of consultations to private or public specialists, fewer indications of radiographs by primary care physicians, lower cost of drug treatment, and less duration of sick leave throughout the follow-up period. There were also differences in favor of neuroreflexotherapy intervention in the cost-effectiveness ratio for pain, disability, and quality of life that persisted in the most optimistic, the most conservative, and the average (break-even case) assumptions. Referral to neuroreflexotherapy intervention improves the effectiveness and cost-effectiveness of the management of nonspecific low back pain.
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JAMA Internal Medicine, 2013
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Spine, 2014
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The Spine Journal, 2011
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The Spine Journal, 2012
Experimental studies suggest that catastrophizing may worsen the prognosis of low back pain (LBP)... more Experimental studies suggest that catastrophizing may worsen the prognosis of low back pain (LBP) and LBP-related disability and increase the risk of chronicity. To assess the prognostic value of baseline catastrophizing for predicting the clinical evolution of LBP patients in routine clinical practice and the association between the evolution of pain and catastrophizing. Prospective study in routine clinical practice of the Spanish National Health Service. One thousand four hundred twenty-two acute and chronic adult LBP patients treated in primary and hospital care. Pain, disability, and catastrophizing measured through validated instruments. Patients were managed according to routine clinical practice. Outcome measures were assessed at baseline and 3 months later. Logistic regression models were developed to estimate the association between baseline catastrophizing score and the improvement of LBP and disability, adjusting for baseline LBP and leg pain (LP) severity, disability, duration of the pain episode, workers' compensation coverage, radiological findings, failed back surgery, and diagnostic procedures and treatments undertaken throughout the study. Another model was developed to estimate the association between the evolution of LBP and the change in catastrophizing, adjusting for the same possible confounders plus the evolution of LP and disability. Models were repeated excluding the treatments undergone after the baseline assessment. Regression models showed that the degree of baseline catastrophizing does not predict the evolution of LBP and disability. Conversely, as the degree of pain improvement increases, so does the odds ratio for improvement in catastrophizing, ranging from three (95% confidence interval [95% CI], 2.00-4.50; p<.001) for improvements in pain between 1.1 and 4 visual analog scale (VAS) points, to 7.3 (95% CI, 3.49-15.36; p<.001) for improvements in pain more than 6.1 VAS points. Similar results were obtained when treatments were excluded from the models. In routine practice, assessing the baseline score for catastrophizing does not help clinicians to predict the evolution of LBP and disability at 3 months.
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The Spine Journal, 2012
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The Spine Journal, 2013
In the context of shared decision-making, a valid estimation of the probability that a given pati... more In the context of shared decision-making, a valid estimation of the probability that a given patient will improve after a specific treatment is valuable. To develop models that predict the improvement of spinal pain, referred pain, and disability in patients with subacute or chronic neck or low back pain undergoing a conservative treatment. Analysis of data from a prospective registry in routine practice. All patients who had been discharged after receiving a conservative treatment within the Spanish National Health Service (SNHS) (n=8,778). Spinal pain, referred pain, and disability were assessed before the conservative treatment and at discharge by the use of previously validated methods. Improvement in spinal pain, referred pain, and disability was defined as a reduction in score greater than the minimal clinically important change. A predictive model that included demographic, clinical, and work-related variables was developed for each outcome using multivariate logistic regression. Missing data were addressed using multiple imputation. Discrimination and calibration were assessed for each model. The models were validated by bootstrap, and nomograms were developed. The following variables showed a predictive value in the three models: baseline scores for pain and disability, pain duration, having undergone X-ray, having undergone spine surgery, and receiving financial assistance for neck or low back pain. Discrimination of the three models ranged from slight to moderate, and calibration was good. A registry in routine practice can be used to develop models that estimate the probability of improvement for each individual patient undergoing a specific form of treatment. Generalizing this approach to other treatments can be valuable for shared decision making.
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Spine, 2007
Prospective cohort follow-up study. To refine the indication criteria for neuroreflexotherapy (NR... more Prospective cohort follow-up study. To refine the indication criteria for neuroreflexotherapy (NRT) in the treatment of subacute and chronic neck (NP), thoracic (TP) and low back pain (LBP) in the Spanish National Health Service (SNHS), by identifying prognostic factors for clinical outcome. NRT consists of the temporary subcutaneous implantation of surgical devices in trigger points. Previous randomized controlled trials have shown its efficacy, effectiveness, and cost-effectiveness for treating subacute and chronic LBP. Clinical audits in routine practice have shown similar results in NP, TP, and LBP patients. All 1514 patients from the SNHS in the Balearic Islands in which a NRT intervention was performed and who were discharged between January 1, 2004, and December 31, 2005, were included in this study. Treatment failure was defined as a baseline score equivalent to or lower than the corresponding one at discharge for local pain, referred pain, or LBP-related disability. Multivariate logistic regression models were developed for each of those variables. Maximal models included reason for referral (NP, TP, or LBP), age, sex, baseline values for each variable, number of days in which the surgical devices used in NRT were left implanted, duration of the current episode, time elapsed since the first episode, and previous failed surgery for the current episode. Calibration of the models was assessed through the Hosmer-Lemeshow test, while discrimination was assessed through the area under the ROC curve and the Nagelkerke R test. When referred to NRT, patients' median (IQR) duration of the episode was 210 (90, 730) days. Failure rates ranged between 9.9% for local pain and 14.5% for disability. Variables associated with a worst prognosis for local pain, referred pain, and disability were surgical devices remaining implanted for a shorter duration and, especially, a longer pain duration. Patients referred for NP were more likely to improve than those referred for TP or LBP. Regarding the evolution of local and referred pain, lesser improvement was observed in the least severe complaint at baseline. Models showed a good calibration. The area under the ROC curve ranged between 0.719 and 0.804, and R ranged between 0.101 and 0.255. A longer duration of the current episode is the worst detected prognostic factor for response to NRT, but prognostic models are inaccurate for predicting the clinical outcome of a given patient. In order to improve the success rate of this technology, these results only support earlier referral for patients complying with current indication criteria.
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Spine, 2010
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Spine, 2011
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Spine, 2011
Cluster randomized controlled trial. To evaluate the effect of a very simple education campaign a... more Cluster randomized controlled trial. To evaluate the effect of a very simple education campaign among community-dwelling 8-year-old schoolchildren. Information has a positive effect on low back pain (LBP) prevention and management. There is sparse evidence on the feasibility and effectiveness of education campaigns focusing on LBP among young schoolchildren. A stratified random sample of 12 schools was randomized to an intervention and a control group. Eight-year-old schoolchildren from these schools were given a questionnaire on LBP prevention and management at baseline, and 15 and 98 days later. On day 8, teachers in the intervention group gave the schoolchildren a Comic Book of the Back, while no intervention was carried out in the control group. After adjusting by possible confounders, generalized estimating equations (GEE) models were developed to calculate the probability of "success" (a score over 80% of the maximum possible one). Six schools (231 children, 46.5%) were assigned to the control group, and 6 (266 children, 53.5%) to the intervention one. At baseline, the percentage of correct answers was above 73% in both groups, with 8 as a median total score in the control group and 7 in the intervention group. GEE showed that the odds ratio for success in the intervention group, when compared with the control group, was 1.61 (95% CI: 1.03-2.52, P = 0.038). The handing out of a Comic Book of the Back slightly improves children's knowledge of appropriate methods for the prevention and management of LBP, and the effect remains significant 3 months after intervention.
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Spine, 2007
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Papers by Francisco Kovacs