Local and remote sustained trigger point therapy for exacerbations of chronic low back pain. A randomized, double-blind, controlled, multicenter trial. [Neuro-reflexotherapy intervention in the treatment of non specified low back pain: a randomized, controlled, double-blind clinical trial]. Effectiveness and cost-effectiveness analysis of neuroreflexotherapy for subacute and chronic low back pain in routine general practice: a cluster randomized, controlled trial.
A randomized, double-blind, controlled, multicenter trial was conducted.
                To assess the efficacy of neuroreflexotherapy in the management of low back pain.
                Neuroreflexotherapy consists of temporary implantation of epidermal devices in trigger points in the back and referred tender points in the ear.
                The rheumatology and rehabilitation departments of three teaching hospitals in Madrid recruited 78 patients with chronic low back pain. These patients were randomly assigned to the control group (37 patients) or to the treatment group (41 patients). Patients in the treatment group underwent one neuroreflexotherapeutic intervention. The control group received sham treatment consisting of placement of the same number of epidermal devices within a 5-cm radius of the target zones. Patients from both groups were allowed to continue drug treatment as previously prescribed. The use of medications during the trial was recorded.
                Patients underwent clinical evaluations on three occasions: within 5 minutes before intervention, within 5 minutes after intervention, and 45 days later. The preintervention assessment was carried out by the physician from each hospital department who included the patient in the study. Each of the two follow-up assessments were carried out independently by two of three physicians who had no connection with the research team. Patients in the treatment group showed immediate lessening of pain compared with the results in patients in the control group. The pain relief was clinically relevant and statistically significant, and it persisted up to the end of the trial.
                Neuroreflexotherapy intervention seems to be a simple and effective treatment for rapid amelioration of pain episodes in patients with chronic low back pain. At this time, the duration of pain relief beyond 45 days has not been evaluated. 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. 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.