EFFICACY OF NEUROREFLEXOTHERAPY IN THE HOSPITAL SETTING
Title.
Efficacy of neuroreflexotherapy (NRT) in
the treatment of non-specific low back pain in the hospitals
of the Spanish National Health System; a controlled, randomized,
double blind clinical trial.
Background.
Back pain represents one of the leading causes
for doctor consultations and work absenteeism in industrialized
countries. It is estimated that the cost it represents to
the public coffers equals approximately 1.7% of the Gross
Domestic Product.
Many procedures are used to treat it, but few have been rigorously
evaluated and only a small part of them have been shown to
be effective, especially in those cases in which the pain
is prolonged. In fact, acute cases have a good prognosis and
tend to cure themselves spontaneously, but chronic cases (in
which the pain lasts more than 90 days) have a poor prognosis
and while they represent a minority of patients, they generate
the immense majority of the costs derived from these ailments.
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 electric and radioactive characteristics
that define them.
A controlled, randomized, double blind clinical trial has
been carried out in Primary Care, which showed the efficacy
of this technology for the treatment of subacute and chronic
cases of mechanical pathologies of the spine (see page 42).
However, the standards of the international scientific community
for a stricter evaluation of the efficacy of a treatment indicate
the advisability of repeating the first clinical trial in
a different setting and with a different research team in
order to check their results.
Therefore, to confirm the efficacy of NRT in the treatment
of these ailments and to meet the most rigorous standards
of scientific evaluation, it was necessary to carry out a
second controlled, randomized and double blind clinical trial
in a different setting.
In addition, the occasion was also used to test the procedure
under the most adverse conditions, including:
-
To evaluate its efficacy in the treatment of the most
chronic patients, who have the worst prognoses.
-
To extend the follow-up period 50% longer in order to
determine whether the improvement caused by the intervention
ends after a certain time.
-
To carry out the study, not in an experimental and controlled
center, as was done previously, but rather under normal
conditions in the teaching hospitals of the National Health
System, with all of the organizational distortions that
entails.
-
To ensure that each patient's situation after the intervention
was assessed on each occasion by more than one doctor,
separately and independently, and to evaluate the concurrence
of these different evaluations so as to ensure an impartial
and objective assessment of the patient's evolution. Additionally,
as in all controlled, double blind clinical trials, these
doctors did not know whether the patient had received
real NRT or the placebo.
Objective.
To confirm the efficacy that neuroreflexotherapy
(NRT) has demonstrated in the treatment of back pain.
Methodology.
It was a controlled, randomized, double blind
clinical trial with a 45-day follow-up. The study included
patients with low back pain lasting more than 12 weeks despite
the treatments received, in whom the periods of pain were
greater than those without during the past 3 years and in
whom there were no signs indicating immediate surgery or any
other serious illnesses.
The study was carried out in four Rheumatology and Rehabilitation
Centers in three university hospitals of the Public Health
System in Madrid. The patients were recruited in these centers
and their participation was voluntary and free.
The patients were randomly assigned to two groups. In the
study group, correct neuroreflexotherapy (NRT) was performed.
In the placebo or control group, the same number of surgical
devices were implanted, but at a distance of 2 to 5 cm from
the place where they should have been. The patients were evaluated
immediately after the intervention, at five minutes and 45
days afterwards.
Pain, mobility-especially the ability to bend forward-which
is most limited in patients with low back pain, the evolution
of quality of life and the administration of medications were
appraised.
Participants, along with the Foundation's
Science Department.
General Office of Research Training and Diffusion
of the Spanish Ministry of Health and Consumer Services. Division
of Epidemiology at the Emory School of Public Health, Department
of Rheumatology of the Ramón y Cajal Hospital, Department
of Rheumatology of the 12 de Octubre Hospital, Department
of Rheumatology of the La Paz Health Complex and Department
of Rehabilitation of the Ramón y Cajal Hospital.
Co-funded by the Kovacs Foundation and the Fund for Health
Research of the Spanish Ministry of Health and Consumer Services.
Status.
The study has been concluded and its results
published. Spine 1997;22:786-797.
To summarize its results:
-
They confirm the efficacy of NRT to improve pain, mobility
and quality of life in patients with chronic low back
pain in whom conservative treatment had previously failed
and in whom there are no indications for immediate surgery.
Significant differences in regard to quality of life were
not objectified, most likely because the measuring instrument
was not very sensitive in noting the differences due to
improvement in back pain.
-
They demonstrate that the effect of NRT is maintained
to the end of the study period (45 days).
-
They reflect that the efficacy demonstrated by NRT in
a primary care setting can be extrapolated to patients
treated in a hospital setting.
Thus, in brief, the results of this second trial are consistent
with those of the first, despite having been repeated by a
different team in a different setting. It should be noted
that very few treatments for chronic back pain have passed
a similar evaluation.
|
Home
