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SAFETY OF NEUROREFLEXOTHERAPY

Title.

Preliminary results on the safety and effectiveness of neuroreflexotherapy neuroreflexotherapy in the treatment of chronic mechanical illnesses of the vertebral spine.

Background.

Neuroreflexotherapy (NRT) consists of the very superficial implantation of surgical material on the nerve endings of the skin without breaking it. This stimulation prompts a neurological mechanism that could improve certain illnesses. All of the surgical material is sterile and used only once and is left implanted between 14 and 90 days. Its implantation is practically painless, does not require anesthesia and is performed on an outpatient basis.

It should be pointed out that, while this kind of treatment is often confused with acupuncture, available scientific studies show that they are not related. The territories stimulated in NRT are defined exclusively by the nerve fibers found in them. They do not coincide with the locations of the acupuncture points nor do they reveal the the electric and radioactive characteristics that define them.

When this study was proposed, there were already scientific studies of a basic kind that helped to define the mechanism that could explain the possible efficacy of this kind of treatment. In accordance with them, in most cases of back disorders, the persistence of pain over a long enough period of time prompted the activation of a neurological mechanism that conditions its chronification and at the same time the appearance of or an aggravation of neurogenic inflammation and muscle contraction that characterize back pains. In NRT, the continuous stimulation of certain nerve fibers in the skin activates specific cells in the spinal medulla. When activated, these cells release a substance capable of deactivating the neurons implicated in the persistence of the pain, neurogenic inflammation and muscle contraction.

The way to prove the supposed efficacy of a treatment consists of carrying out a randomized, controlled, double blind clinical trial.This method of research allows one to quantify the intrinsic effect of a treatment, apart from suggestion or other factors that could influence it. However, a controlled clinical trial is a complex method which requires a substantial investment in time, resources and effort, and according to the Foundation's work system, it makes no sense to begin one without first exploring whether or not the initial results the technology obtains justify it, by using simpler and less costly systems of evaluation. Thus, before carrying out a controlled clinical trial to evaluate the efficacy of neuroreflexotherapy for the treatment of back disorders, it was necessary to explore its clinical effect.

Additionally, before beginning a possible line of study on this technology, it was essential to collect data on its safety.

Objective.

To determine the safety of neuroreflexotherapy (NRT) and to collect initial data on its effectiveness in the treatment of back pain in order to assess the advisability of carrying out clinical trials evaluating its efficacy.

Methodology.

A prospective cohort study with a 6-month follow-up was made.

Clinical data was collected from 2,751 patients with back pain due to some some mechanical pathology of the spine, in which the pain was present for more than 24 months. The period with pain had to be greater than that without pain; the discomfort had to be resistant to medication, and there were no indications for urgent surgery.

The patients were recruited at the Kovacs Back Unit in Asturias. Their participation was voluntary and free.

All patients received neuroreflexotherapy. Their clinical status was evaluated immediately before the therapy and during the next 6 months. The evolution of their pain was assessed, as well as their daily activity (including work) and the use of medications and rehabilitation.

Participants, along with the Foundation's Science Department.

Kovacs Back Unit of Asturias.

The study was funded entirely by the Kovacs Foundation.

Status.

The study was concluded and its results published in the review Medicina del Trabajo 1992; 1:433-443.

In short, the results show that NRT is safe and suggest its effectiveness in the treatment of mechanical pathologies of the spine that are resistant to other conservative treatments. They also recommend carrying out clinical trials to evaluate its efficacy.