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

Background.

The data available supported the possible effectiveness of NRT intervention in the treatment of back pain. Back pain is one of the main causes of medical consultation and occupational absenteeism in industrialized countries. It is estimated that its public cost amounts to 1.7% of the gross national product.

Additionally, the outcome of the available treatments was unsatisfactory, especially for patients with chronic pain. It was thus especially important to evaluate accurately the possible efficacy of treatment using NRT intervention. It was therefore necessary to conduct a controlled, randomized, double blind clinical trial.

Objective.

To assess the efficacy of NRT intervention in the treatment of back pain.

Methodology.

Controlled, randomized, double blind clinical trial.

The patients screened in this study were subjects with low -lumbar- back pain of more than 7 days' duration, despite the pharmacological treatment received, with no signs of need for urgent surgery, and with no signs of serious illnesses. NRT intervention was performed at the Kovacs Back Unit in Palma de Majorca, but patients were originally recruited in the Primary Care Centers of the Health Public System in Majorca. All patients gave their voluntary consent prior to their participation in the trial.

Patients were randomly assigned to two treatment groups. The active treatment group underwent a correct NRT intervention. The placebo - or control - group was implanted the same number of surgical elements but at a distance of from 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 30 days later. Those patients that were well at day 30 were also evaluated at day 180.

Due to ethical reasons, patients whose pain persisted at day 30 were excluded from the study. Patients who had been assigned to the placebo group were offered a true NRT intervention free of charge.

Evaluation was performed for pain, capacity of movement daily activity, taking of medications, number of days on sick leave, and medical and labor costs generated by patients during the study period.

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

Kovacs Back Units in Palma de Majorca. National Health Institute of the Ministry of Health, the following Primary Care Centers in Majorca: Son Serra/La Vileta, Camp Redó, Coll d'en Rebassa, El Arenal, Marratxi, Son Gotleu, Calviá, Inca, Son Ferriol, Escola Graduada, Esporlas, Son Cladera, Emili Darder, Son Sardina, Algaida, Pont d'Inca, Campanet, Santanyi.

Co-financed by the Kovacs Foundation, the ONCE Foundation, the Spanish Red Cross and the Health Research Fund of the Spanish Ministry of Health.

Results.

Published in the journal Medicina Clínica (Efficacy of NRT intervention in the treatment of low back pain: a controlled, randomized, double blind clinical trial. Med Clin (Barc) 1993; 101:570-5). In summary results show that: