Physician-Related Variability in the Outcomes of an Invasive Treatment for Neck and Back Pain: A Multi-Level Analysis of Data Gathered in Routine Clinical Practice.

Neuro-reflexotherapy (NRT) is a proven effective, invasive treatment for neck and back pain. To assess physician-related variability in results, data from post-implementation surveillance of 9023 patients treated within the Spanish National Health Service by 12 physicians were analyzed. Separate multi-level logistic regression models were developed for spinal pain (SP), referred pain (RP), and disability. The models included all patient-related variables predicting response to NRT and physician-related variables. The Intraclass Correlation Coefficient (ICC) and the Median Odds Ratio (MOR) were calculated. Adjusted MOR (95% CI) was 1.70 (1.47; 2.09) for SP, 1.60 (1.38; 1.99) for RP, and 1.65 (1.42; 2.03) for disability. Adjusted ICC (95%CI) values were 0.08 (0.05; 0.15) for SP, 0.07 (0.03; 0.14) for RP, and 0.08 (0.04; 0.14) for disability. In the sensitivity analysis, in which the 6920 patients treated during the physicians' training period were excluded, adjusted MOR was 1.38 (1.17; 1.98) for SP, 1.37 (1.12; 2.31) for RP, and 1.25 (1.09; 1.79) for disability, while ICCs were 0.03 (0.01; 0.14) for SP, 0.03 (0.00; 0.19) for RP, and 0.02 (0.00; 0.10) for disability. In conclusion, the variability in results obtained by different NRT-certified specialists is reasonable. This suggests that current training standards are appropriate.

Validation of the NCCN-IPI for diffuse large B-cell lymphoma (DLBCL): the addition of ß2 -microglobulin yields a more accurate GELTAMO-IPI.

The study included 1848 diffuse large B-cell lymphoma (DLBCL)patients treated with chemotherapy/rituximab. The aims were to validate the National Comprehensive Cancer Network International Prognostic Index (NCCN-IPI) and explore the effect of adding high Beta-2 microglobulin (ß2M), primary extranodal presentation and intense treatment to the NCCN-IPI variables in order to develop an improved index. Comparing survival curves, NCCN-IPI discriminated better than IPI, separating four risk groups with 5-year overall survival rates of 93%, 83%, 67% and 49%, but failing to identify a true high-risk population. For the second aim the series was split into training and validation cohorts: in the former the multivariate model identified age, lactate dehydrogenase, Eastern Cooperative Oncology Group performance status, Stage III-IV, and ß2M as independently significant, whereas the NCCN-IPI-selected extranodal sites, primary extranodal presentation and intense treatments were not. These results were confirmed in the validation cohort. The Grupo Español de Linfomas/Trasplante de Médula ósea (GELTAMO)-IPI developed here, with 7 points, significantly separated four risk groups (0, 1-3, 4 or ≥5 points) with 11%, 58%, 17% and 14% of patients, and 5-year overall survival rates of 93%, 79%, 66% and 39%, respectively. In the comparison GELTAMO IPI discriminated better than the NCCN-IPI. In conclusion, GELTAMO-IPI is more accurate than the NCCN-IPI and has statistical and practical advantages in that the better discrimination identifies an authentic high-risk group and is not influenced by primary extranodal presentation or treatments of different intensity.

Predicting outcomes of neuroreflexotherapy in patients with subacute or chronic neck or low back pain.

BACKGROUND CONTEXT: 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. PURPOSE: 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. STUDY DESIGN AND SETTING: Analysis of data from a prospective registry in routine practice. PATIENT SAMPLE: All patients who had been discharged after receiving a conservative treatment within the Spanish National Health Service (SNHS) (n=8,778). OUTCOME MEASURES: Spinal pain, referred pain, and disability were assessed before the conservative treatment and at discharge by the use of previously validated methods. 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. RESULTS: 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. CONCLUSIONS: 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.

Neuro-reflexotherapy for the management of myofascial temporomandibular joint pain: a double-blind, placebo-controlled, randomized clinical trial.

PURPOSE: To assess the efficacy of neuro-reflexotherapy intervention (NRT) for treating temporomandibular joint dysfunction attributed to myofascial pain. Neuro-reflexotherapy intervention consists of the temporary implantation of epidermal devices in trigger points in the back and ear. It has shown efficacy, effectiveness, and cost-effectiveness in treating subacute and chronic common back pain. No study, however, has explored its efficacy in treating myofascial temporomandibular joint pain (MF/TMJP). PATIENTS AND METHODS: This was a randomized, double-blind, placebo-controlled trial. Patients with MF/TMJP for more than 3 months in spite of conservative treatment, and with no evidence of major structural damage in the joint, were recruited at the Maxillofacial Department of the Hospital Clínico Universitario, a teaching hospital in Madrid, Spain. Patients were randomly assigned to an intervention group and to a control group. Patients in the treated group underwent 2 NRTs, immediately after baseline assessment and 45 days later. Sham interventions in the control group consisted of placement of the same number of epidermal devices within a 5-cm radius of the target zones. In both groups, conservative treatment during follow-up was allowed and recorded. Patients underwent clinical evaluations on 4 occasions: 5 minutes before intervention, 5 minutes after intervention, and 45 and 90 days later. The preintervention assessment was performed by the physician at the hospital service who included the patient in the study. The 3 follow-up assessments were performed independently by 1 of 2 physicians who had no connection with the research team, and who were blinded to patients' assignments. The primary outcome variable was level of pain severity during jaw movements at the last assessment (90 days), and the key comparison of interest was change in pain over time (pain levels at baseline and at 90 days). Level of pain was measured using a visual analog scale (VAS). RESULTS: Fifty-one patients with MF/TMJP were recruited into the study. Random assignment allocated 27 patients to the intervention group, and 24 to the control group. Differences in pain severity in favor of the intervention group appeared immediately after the intervention, persisted for 45 days, and increased after the second intervention. Differences at last follow-up were highly clinically and statistically significant (4 to 5 points on the VAS, P = .000), allowing for patients in the intervention group to cease drug treatment (P = .005). There were no differences in the evolution of crepitus or clicking in the joint. There were no clinically relevant side effects associated with the intervention. CONCLUSIONS: For patients in whom conservative treatment has failed, NRT improves the chronic pain associated with MF/TMJP syndrome.

Prognostic factors for neuroreflexotherapy in the treatment of subacute and chronic neck and back pain: a study of predictors of clinical outcome in routine practice of the Spanish National Health Service.

STUDY DESIGN: Prospective cohort follow-up study. OBJECTIVES: 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. SUMMARY OF BACKGROUND DATA: 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. PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Effectiveness and cost-effectiveness analysis of neuroreflexotherapy for subacute and chronic low back pain in routine general practice: a cluster randomized, controlled trial.

STUDY DESIGN: A cluster randomized, controlled trial was performed. OBJECTIVES: 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. SUMMARY OF BACKGROUND DATA: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Referral to neuroreflexotherapy intervention improves the effectiveness and cost-effectiveness of the management of nonspecific low back pain.