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.