The efficacy of NRT intervention in the Hospitals.

Título.

The efficacy of NRT intervention in the treatment of low back pain within the hospitals of the Spanish National Health System; a controlled randomized, double blind clinical trial.

Background.

NRT intervention has shown to be efficacious in the treatment of back pain. The first clinical trial that proved its efficacy was performed in the primary care setting.

The international scientific community standards for the evaluation of the efficacy of a treatment with the greatest degree of strictness establish the convenience of performing two controlled, randomized and double blind clinical trials, in different settings.

Therefore, in order to confirm the efficacy of NRT intervention in the treatment of these disorders and to fulfill the strictest scientific evaluation standards, it was necessary to perform a second controlled, randomized, double blind clinical trial in a different setting.

Also, the occasion was utilized to evaluate the procedure in the most adverse conditions, such as:

a) Assess its efficacy in the treatment of the most chronic patients, who have the worst prognosis.

b) To extend the period of follow-up by 50% in order to determine if after this time the improvement effect of the intervention has faded.

c) Not to conduct the study in an experimental and controlled Center, as in the previous study, but under normal conditions in teaching hospitals of the National Health System, with all the operative distortions that this entails.

d) After the intervention, each patient had to be assessed by more than one physician on each evaluation visit, in a separate and independent manner. The consistency of these different evaluations was assessed in order to ensure an impartial and objective of the patients' evolution. Also, as in any controlled double-blind trial, these physicians ignored which patient had received a true NRT intervention or placebo.

Objective.

To confirm the efficacy of NRT intervention demonstrated in previous trials, for the treatment of back pain.

Methodology.

Controlled, randomized, double blind clinical trial.

Patients selected for this study were subjects with low -lumbar- back pain, of 12 or more weeks duration despite the applied treatments, who had experienced, in the preceding 3 years, greater periods with pain than without it, and who had no need of urgent surgery and had no severe illnesses.

The study was carried out in five Departments of Rheumatology and Rehabilitation of three teaching hospitals belonging to the Public Health System in Madrid. Patients were recruited in these Departments and their participation was voluntary.

Patients were randomly assigned to two groups. A correct NRT intervention was performed in the active group. The placebo -or control- group was implanted the same number of surgical elements but at a distance of 2 to 5 cm from the site where implantation was indicated. Patients were evaluated immediately before the intervention, in the 5 minutes following the intervention, and 45 days later.

Pain, the ability of forward flexion, the improvement in quality of life and administration of drugs were assessed.

Participating Centers, jointly with the Foundation's Scientific Department.

The General Deputy office of Research Training and Diffusion, of the Spanish Ministry of Health; Division of Epidemiology, Emory School of Public Health; Rheumatology Departments, Hospital Ramón y Cajal, Hospital 12 de Octubre, Ciudad Sanitaria La Paz; and the Rehabilitation Department, Hospital Ramón y Cajal.

Co-financed by the Kovacs Foundation and the Health Research Fund of the Spanish Ministry of Health.

Results.

Published in the journal Spine (Kovacs FM, Abraira V, Pozo F, Kleinbaum D, Beltrán J, Mateo I, Pérez de Ayala C, Peña A, Zea A, González-Lanza M, Morillas L. Local and remote sustained trigger point therapy for exacerbation of chronic low back pain: A randomized, double-blind, controlled, multicenter trial, Spine 1997; 22:786-797).

This study has also been presented in the following Congresses:

Kovacs FM, Gestoso M, Mufraggi N, and Gil del Real MT. Neuroreflexotherapy for Low Back Pain: Clinical Evidence and Biological Substrate, Sindromi Lombalgiche e Lombosciatalgiche, Mestre, Italy, 1998. Published in "Lombalgie e Lumboscialtagie". F. Ceccerelli, A. Ricciardi, editors. Edizioni Librería Cortina, Turin, 1998.

Kovacs FM. Neuroreflexotherapy Intervention for Exacerbation of Chronic Low Back Pain: Clinical Evidence and Biological Substrate. Third Interdisciplinary World Congress on Low Back Pain, Vienna, Austria, 1998. Published in Vleeming A, Mooney V, Tilscher H, Dorman T, Snijders editors.: 3rd Interdisciplinary World Congress on Low Back and Pelvic Pain. Vienna, 19 - 21 Nov 1998:83.

In summary:

a) Results confirm the efficacy of NRT intervention to improve pain, mobility and quality of life in chronic patients with back pain in whom previous conservative treatments have failed and who have no indication for urgent surgery.

b) They show that the effect of NRT intervention is maintained throughout the end of the study period (45 days).

c) They reveal that the efficacy of NRT intervention proven in the primary care setting is extrapolated to patients seen in a hospital setting.