EFFICACY OF NEUROREFLEXOTHERAPY IN PRIMARY CARE
Title.
The efficacy of neuroreflexotherapy (NRT)
in the treatment of non-specific low back pain in Primary
Care of the Spanish National Health System; a controlled,
randomized and 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.
Available data suggest that this technology was safe and
could be effective in treatment (see page 40, section 3.17)
so that it was necessary to carry out a controlled clinical
trial to evaluate that possibility.
Objective.
To evaluate the efficacy of NRT in the treatment
of back pain.
Methodology.
It was a controlled, randomized, double blind
clinical trial. For this study, patients were selected who
had suffered low back pain for more than 7 days despite having
already received pharmacological treatment and in whom there
were no signs indicating the need for emergency surgery or
reflecting the presence of other serious illnesses such as
cancer or infection. Patients were recruited for the study
from Primary Care centers of the Public Health System of Mallorca
and were referred to the Kovacs Back Unit at Palma de Mallorca
where they were treated. Their participation was voluntary
and free.
The patients were randomly assigned to two groups. In the
study group, correct NRT was carried out. In the placebo,
or control group, the same number of surgical devices were
implanted, but at a distance of 1 to 5 cm from the target
points where they should have been placed. The patients were
evaluated immediately before the intervention, five minutes
after completion and 30 and 180 days later.
For ethical reasons, at 30 days, those patients who continued
with pain were excluded and those who had been assigned to
the placebo group were offered real NRT treatment free of
charge.
Pain, movement, daily activity, medication use, the number
of days on sick leave and the medical and labor costs generated
by the patients during the period of the study were appraised.
Participants, along with the Science Department
of the Kovacs Foundation.
Kovacs Back Unit of Palma de Mallorca, National
Institute of Health (INSALUD), Spanish Red Cross, Ministry
of health and Consumer Protection and the following Health
Centers in Mallorca: Son Serra/La Vileta, Camp Redó,
Coll d'en Rebassa, El Arenal, Marratxí, Son Gotleu,
Calviá, Inca, Son Ferriol, Escola Graduada, Esporlas,
Son Cladera, Emili Darder, Son Sardina, Algaida, Pont d'Inca,
Campanet y Santanyí.
Co-funded by the Kovacs Foundation, ONCE Foundation, Spanish
Red Cross, and the Fund for Health Research of the Spanish
Ministry of Health and Consumer Protection.
Status.
The study was concluded and its results published
(Kovacs FM, Abraira V, López Abente G. Eficacia de
la intervención NRT en el tratamiento de la lumbalgia
inespecífica: un ensayo clínico controlado,
aleatorizado, a doble ciego. Med Clin (Barc) 1993;101:570-5).
To summarize, they show that:
-
NRT is effective in improving the evolution of patients
with back pain resistant to medication and in whom there
are no criteria for emergency surgery.
-
The intervention's effect appears rapidly, usually within
minutes and lasts until the end of the study period.
-
This is true, despite the fact that the patients included
were very chronic and therefore had very bad prognoses.
While the study design established that the patients had
to have pain for more than 7 days, the patients in the
study had suffered pain an average of more than 18 months.
-
Contrasted data could not be obtained on the duration
of the effect 6 months after the intervention. The reason
was that all of the patients from the control group continued
to feel pain when evaluated on day 30, so that they were
all excluded. Thus, only the patients from the study group
were included in the follow-up 6 months after the intervention.
In general, they continued to show significant improvement,
but conclusive data could not be gathered because there
was no control group with which to compare their evolution.
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